|
Kennedy 2019110
Cochrane review
48 studies
Studies conducted in Europe, USA, Hong Kong, New Zealand, Thailand, and Australia
| Participants had to be randomised in trials assessing one of the following comparisons:
Automatically adjusted-CPAP (auto-CPAP including forced oscillation technique) versus fixed CPAP (fixed pressure setting); Bi-level PAP/non-invasive ventilation (NIV) versus fixed CPAP; Humidification plus CPAP versus fixed CPAP;
|
N= 2819 (48 studies) Participants were adults of either sex with a diagnosis of OSA, based on history and results of sleep studies.
The sleep studies were either oximetry studies showing desaturation index (DI) of at least 5 per hour or of respiratory movements and airflow to give an apnoea hypopnoea index (AHI) of at least 5 per hour.
The populations had similar characteristics across the seven comparisons considered by this review. Average age of the study populations ranged between 49 and 55 and average body mass index was between 32 and 35 kg/m2. Baseline sleep disruption as measured by AHI was severe and ESS scores indicated that the study populations had excessive daytime sleepiness (11 to 16). One study recruited people with co-existing sleep apnoea and obesity hypoventilation syndrome (Masa 2015).
Trials assessing interventions in people with central sleep apnoea and where sleep apnoea was related to sleeping position were excluded from the review.
|
Primary outcomes
Usage of CPAP, measured as initial acceptance, where data were available, and subsequent usage as measured by:
counter output that records the cumulative time that power is turned on to a CPAP machine (this does not provide information on actual time of day and duration of CPAP used each 24-hour period); microprocessor and monitor that measures the pressure at the mask; subjective patient reports of the duration of CPAP use.
Data for this outcome could be measured as mean differences in hourly use per participant per night or as the number of participants who used machines for more than 4 hours per night.
Secondary outcomes
Withdrawals Symptom scores, such as the Epworth Sleepiness Scale (ESS), Stanford Sleepiness Score and nasal symptoms. Quality of life or Health Status, such as the Functional Outcomes of Sleep Questionnaire (FOSQ) and Sleep Association Quality of Life Index (SAQLI) scores. We analysed data from the Short Form 36 but we did not use it as the basis for the Summary of Findings tables Apnoea hypopnoea index (AHI). Blood pressure outcomes. Treatment pressure (for auto-CPAP). Adverse events.
For the comparison of humidification and CPAP versus CPAP alone, nasal symptoms were considered as an additional outcome. This was intended to capture the effects of humidity directly where the mechanism of action is targeted
|
Studies that were conducted as short-term laboratory based interventions, since they did not intend to capture the effects of interventions administered on a nightly basis at home. We excluded studies that were less than two weeks in duration because we were primarily interested in the effects of pressure modification in the context of ongoing use of CPAP were excluded from the review.
Average study duration was between 12 and 16 weeks in studies comparing auto-CPAP, Bi-level PAP/non-invasive ventilation with fixed pressure CPAP. Studies comparing additional humidification with fixed pressure CPAP had shorter average durations (8 and 6 weeks respectively).
Note:
We have not included all studies from the Cochrane review as the GC felt that some of the interventions/comparisons were not relevant. Comparisons not included: CPAP with expiratory pressure relief versus fixed CPAP; Auto bi-level PAP versus fixed CPAP; Auto-flex versus fixed CPAP; Bi-level PAP with pressure relief (ABRP-PAP) versus fixed CPAP;CPAP with expiratory pressure relief triggered on wakefulness versus fixed CPAP.
Majority of the studies for each comparison was in people with severe OSAHS (based on mean AHI) hence they have been categorised as severe OSAHS. When moderate OSAHS studies were included in this strata we have downgraded the evidence for indirectness.
|
| Auto-CPAP with fixed CPAP – 36 studies |
|---|
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Berry 201418
Randomised, open label, parallel group, singe centre trial
|
Auto-CPAP versus Home PSG CPAP titration over followed by fixed pressure CPAP treatment.
Study duration: 6 weeks
|
N = 156 participants. Age: 59 years; BMI: 36kg/m2; AHI: 28.5 ESS: 14.8.
Inclusion criteria: AHI ≥ 10/hour; ESS ≥ 8; Living within 200 miles of treatment centre; Age > 18 years
Exclusion criteria: Previous CPAP therapy; shift work; unstable depression/psychosis; non-adherence with medication; COPD; uncontrolled hypertension or restless legs syndrome; narcolepsy; supplemental oxygen use; congestive heart failure; nightly narcotic use; hypoventilation; neuromuscular weakness; regular sleep of < 4 hours per night; low baseline SaO2; central apnea index > 5/hour.
|
|
This study was supported by a research grant from the Res Med Foundation and an unrestricted research grant from Philips Respironics. Both grants were made to the North Florida Foundation for Research and Education.
Study included in the Cochrane review
Moderate OSAHS based on mean AHI
|
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Bloch 201823
Randomised, double-blind, parallel group trial
|
Auto-CPAP v fixed CPAP
Study duration: 2 years
|
N= 208 participants (177 M/31 F). Age 55.5; BMI 32.7kg/m2; AHI 48.4; ESS 13.
Inclusion Criteria: Epworth Sleepiness Score > or = 8; AHI > or = 10/hour; Age 18-75.
Exclusion Criteria: Psychophysiological incapacity to perform questionnaires, other sleep disorders, psychiatric disease, previous CPAP therapy, previous uvulopalatopharyngoplasty, chronic nasal obstruction, cancer, COPD, with FEV1 < 50% predicted, symptomatic cardiovascular disease, previous stroke, cheyne-Stokes respiration, chronic pain syndromes, fibromyalgia, drug or alcohol addiction
|
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The study was supported by the Swiss National Science Foundation, the lung leagues of Zurich, St. Gallen and Thurgau and by unconditional grants from the respironics Foundation and resMed Switzerland. This was an investigator initiated trial, and the commercial companies were not involved in study design, data acquisition and analysis or writing the manuscript.
Study included in the Cochrane review.
Severe OSAHS based on mean AHI
|
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Castronovo 200634
Randomised, cross-over study.
|
Auto-CPAP versus fixed CPAP (RemStar machines set in 2 different modes)
Study duration: 2 × 4 weeks
|
N = 50 participants. 40 completed and analysed. Age: 53 years. No other baseline details reported.
Inclusion criteria: Severe OSA (RDI > 30)
|
|
No details available on funding
Study included in the Cochrane review
No mean AHI available from Cochrane review
|
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Chang 201536
Prospective, randomised, crossover study.
|
AutoCPAP versus Fixed CPAP
Study duration: 12 weeks
|
N = 19 participants. M/F 18/1. Age 46.2; BMI 30.2 kg/m2; AHI 59.7; ESS 9.6 Inclusion criteria: Age > 20, AHI > 15, consent to wear CPAP. Exclusion criteria: not consenting to positive pressure device, treatment for mood disorders such as anxiety and depression.
|
Quality of life (SF-36)AHI Treatment pressure |
Study included in the Cochrane review
Severe OSAHS based on mean AHI.
Funding not declared.
|
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Damjanovic 200951
Controlled, parallel group trial
|
4 groups. Auto adjusting CPAP + intensive support versus fixed CPAP + intensive support.
Study duration: 9 months
|
N = 100 participants. Newly diagnosed OSA patients. 78 male and 22 female; mean +SD age
57+12 yrs; BMI 31+5 kg/m2. Inclusion criteria: AHI>15, with or without corresponding daytime symptoms.
Exclusion criteria 1. global respiratory failure 2. central sleep apnoea syndrome 3. severe mental or psychological impairment.
|
|
No information on funding
Study included in the Cochrane review.
Study included in the Cochrane review
No mean AHI available from Cochrane review.
|
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d’Ortho 200050
Randomised, single-blind, crossover study
|
Auto-CPAP versus fixed CPAP.
No washout period
Study duration: 2 × 4 week treatment arms
|
N (assumed) = 25; 22 M:3 F; mean age 57 (11); mean AHI 57.8 (5.8)
Inclusion criteria: OSA confirmed by PSG; AHI > 10/hr; ATS recommended indication for CPAP treatment
|
|
Funded by Institut National de la sante et de la Recherche Medicale & by Nellcor-Puritan Bennett.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Ficker 200362
Randomised, parallel group study.
|
Auto-CPAP (forced oscillation technique) versus fixed CPAP
Conference abstract reported 8 weeks duration (Published paper reported 2 nights data from laboratory studies).
|
N = 100 participants. Mean age: 54.3; BMI: 31.8 kg/m2; AHI: 47.9; ESS: 12.6
Inclusion criteria: Diurnal somnolence (>/= 8 on ESS); AHI > 10; written consent
Exclusion criteria: Prior CPAP therapy; central sleep apnoea or Cheyne-Stokes respiration; severe nasal obstruction or other conditions contraindicating CPAP treatment; COPD (FEV1 < 70% predicted); congestive heart failure (NYHA III or IV)
|
|
Funding information not available (conference abstract).
Study included in the Cochrane review.
Severe OSAHS based on mean AHI
|
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Fietze 200766
Randomised, double blind, parallel group study. Participants randomised for 2 night crossover and retained device assigned on second night for subsequent 6 week period.
| Auto-CPAP versus fixed pressure CPAP (established by manual titration after 2 night crossover study) Study duration: 6 weeks |
N = 21 (20 men and 1 woman) participants. Mean age 54.2; BMI: 30.9 kg/m2. AHI: 41.8. ESS: 12.9
Inclusion criteria: AHI >10 or excessive sleepiness (if AHI <10). Participants who did not have excessive sleepiness at baseline also eligible if AHI >20
Exclusion criteria: Other sleep disorders (e.g. restlessleg syndrome or periodic leg movement syndrome; cardiac, pulmonary or other medical disorders; psychiatric/neurological disorders; abuse of sleep-inducing agents or other drugs; suspected or confirmed central sleep apnea syndrome; prior OSA treatment (e.g. CPAP, oral devices or surgery).
|
|
Funding: ‘This study was supported by an unrestricted grant from Respironics Inc.’. No declarations reported from authors.
Study included in the Cochrane review.
Severe OSAHS based on mean AHI
|
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Galetke 200873
Randomised, single-blind, cross-over study (participants not informed of order/setting)
|
Auto-CPAP versus fixed pressure CPAP
Same machine delivered the different treatment pressure settings
Study duration: 2 × 8 weeks
|
N = 20 participants completed & analysed. Mean age: 56 years. AHI: 33; ESS: 10.3 Inclusion criteria: New diagnosis of OSA (diagnosis established through polysomnography, AHI > 10) Exclusion criteria: COPD, congestive heart failure and other serious medical disorders
|
|
Study included in the Cochrane review
Funding information not provided
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Hudgel 200098
Randomised, single-blind, cross-over study.
|
Auto-CPAP versus fixed CPAP.
No washout.
Study duration: 2 × 12 week treatment periods
|
N = 60 (53 with OSA and 7 with Upper Airway Resistance Syndrome (UARS)). 21 withdrawals 2 stopped due to medical complications (not stated) and the rest did not complete the study. Further 6 did not have machine usage data. (21 M/18 F). Total number of OSA patients completing trial is 29. Data analysed for 33 patients which included 4 patients with UARS Mean age: 46 years; AHI 30; BMI: 42 kg/m2
Inclusion criteria: Diagnosed OSA or UARS (confirmation by polysomnography)
Exclusion criteria: Prior CPAP treatment, facial/pharyngeal abnormalities requiring surgery, chronic airways disease necessitating bronchodilator usage, obesity hypoventilation syndrome, shift workers, congestive heart failure, seizure disorder, mental retardation, sedative/antidepressant/hypnotic treatment
|
|
Funding information not provided
Included in Cochrane review
Severe OSAHS based on mean AHI
|
|
Hukins 2004102
Randomised, single-blind, crossover study.
|
Auto-CPAP (Autoset T) versus fixed pressure CPAP
Study duration: 2 × 8-week treatment periods
|
N = 55 adults (48M/7F) randomised (46 completed). Age: 50 years; BMI: 35 kg/m2; AHI: 54; ESS: 12.5
Inclusion criteria: AHI >/= 5; optimal treatment PSG determined optimal treatment pressure; no previous home use of CPAP
Exclusion criteria: Significant comorbidity; complication (e.g. hypercapnic respiratory failure); non-obstructive sleep apnoea; patients unable to use masks with Autoset T machines
|
|
This was an industry supported study by ResMed Australia.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Hussain 2004105
Randomised, single-blind, crossover study
|
Auto-CPAP versus fixed CPAP
Study duration: 2 × 4-week treatment periods (washout 2 weeks)
|
N = 10 (10 completed the study). Mean age: 44.98 (SD 9.7); 9M; AHI: 47.2 (SD35.6); BMI: 35.9 kg/m2 (SD 12.9); ESS: 11.1 (SD 6.4)
Inclusion criteria: CPAP-naive at baseline; symptomatic OSA (AHI > 15/h)
Exclusion criteria: not described
|
|
This study was funded by Respironics Inc., Murrysville, PA.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Jarvis 2006107
Randomised, crossover study.
|
Modified APAP (bi-level pressure mode) versus fixed CPAP
Study duration: 2 × 2 weeks
|
N = 20
Inclusion criteria: Diagnosed with obstructive sleep apnoea (OSA); established on CPAP therapy
|
|
Resmed sponsored the study but no other details were available.
Study included in the Cochrane review
mean AHI not available from cochrane review.
|
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Kendrick 2001265
Randomised, double-blind, cross-over study
|
Auto-CPAP versus fixed CPAP
Study duration: 2 × 2-week treatment periods
|
N = 41 (38M/3F). 27 completed the stud. Mean age: 52.4 years; BMI: 32.3 kg/m2; ESS 13.9
Eligibility criteria not provided
|
Machine usage Symptoms (ESS) AHI Quality of life (SF-36)
|
Funding information not available (conference abstract).
Study included in the Cochrane review
Mean AHI not available from Cochrane review
|
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Konermann 1998113
Randomised, single-blind, parallel group study.
|
Auto-CPAP versus fixed CPAP
Study duration: 3 to 6 weeks
| N = 50 participants (assumed) (44 M/6F); Age 53.5. No other baseline details available. |
|
Funding information not provided Sleep study following treatment done between 3 to 6 months
Study included in the Cochrane review
Mean AHI not available from Cochrane review
|
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Marrone 2004132
Randomised, single-blind, crossover study.
|
Auto-CPAP versus fixed CPAP
Study duration: 2 × 4 weeks.
No washout described
|
N = 22 participants (21M); mean age 53.45; BMI: 32.9 kg/m2; ESS: 16.3
Inclusion criteria: Newly diagnosed OSA; AHI >/= 30
Exclusion criteria: Not described
|
|
Funding: ‘This study was supported by Air Products Medical GmbH
Study included in the Cochrane review
Severe OSAHS based on AHI
|
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Massie 2003145
Randomised, single-blind, crossover study.
|
Auto-CPAP versus fixed CPAP.
No washout period.
Study duration: 2 × 6-week treatment periods
|
N = 46 participants (36 M/10 F) 1 drop-out and 1 data unavailable from machine. Mean age: 49; BMI: 32kg/m2
Inclusion criteria: 18 to 65 years; symptomatic OSA; AHI > 15; > 10 cm H2O to correct AHI
Exclusion criteria: Pre-existing lung disease; awake resting SaO2 < 90%; 10 or more central apneas/hr; patients taking medication considered to interfere with sleep respiration.
|
Machine usage (average hours used & % days used) AHI Quality of life (SF-36 score reported by domain) Symptoms (ESS & sleep diary score)
|
Supported by a grant from ResMed Corporation. One of the authors (Neil Douglas) declared a role as medical advisor to ResMed.
Study included in the Cochrane review
Mean AHI not available from Cochrane review
|
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Meurice 1996153
Randomised, parallel group study.
|
Auto-CPAP versus fixed CPAP
Study duration: 2 × 3-week treatment periods
|
N = 16 participants. Mean age: 54; BMI: 34.2 kg/m2; AHI: 43.6; ESS: 14.8
Inclusion criteria: Diagnosis of OSA (confirmed by polysomnography; untreated OSA)
Exclusion criteria: Not reported
|
|
Funding information not provided.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Meurice 2007150
Randomised, multicentre, parallel group trial
|
Four Auto-CPAP machines assessed:
GK 418 P, 3.1 version AutoSet Spirit, 302 version PV 10I, firmware 0.92 version Somnosmart 1, 2.02 version
All 4 compared against fixed pressure CPAP
Study duration: 24 weeks
|
N = 83. Mean age: 56 years; AHI: 52; ESS: 11.5
Inclusion criteria: New diagnosis of OSA; CPAP-naive; AHI > 30
|
|
Study included in the Cochrane review
Funding information not provided.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Nolan 2007185
Randomised, single-blind, cross-over study
|
Auto-CPAP versus fixed pressure CPAP
Study duration: 2 × 8-week treatment periods
|
Randomised: 34; Completed: 29. Mean age: 53 years; BMI: 29.9kg/m2; AHI: 14.7; ESS: 12.3
Inclusion criteria: Mild to moderate OSA (AHI 5-30)
Exclusion criteria: Not reported
|
|
This was not an industry supported study.
Study included in the Cochrane review
Mild OSAHS based on mean AHI
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Noseda 2004188
Randomised, single-blind, cross-over study.
|
Auto-CPAP versus fixed CPAP.
Need for pressure assessed over a 14-night run-in period with auto-CPAP.
No washout period described Study duration: 2 × 8-week treatment periods
|
N = 27 participants (23M/4F).
Withdrawals: 3. Total completed and analysed N = 24. Mean age: 49 years; BMI: 32.3kg/m2; AHI: 50.9; ESS 10.7
Inclusion criteria: AHI > 20/h; MAI: > 30/h; high variability of within night pressure to correct AHI
Exclusion criteria: Prior treatment with CPAP; central OSA/Cheyne Stokes; major facial abnormality; night/shift work; severe chronic heart failure/COPD; seizure disorder; mental retardation; sedative, hypnotic or antidepressant therapy; previous UPPP; prolonged hypoventilation during REM
|
|
Study included in the Cochrane review
Funding information not provided.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Nussbaumer 2006189
Randomised, crossover study.
|
Auto-CPAP versus fixed CPAP
No washout period described
Study duration: 2 × 4-week treatment periods
|
N = 38 (30 completed the study & contributed to the analysis). 27 M/3F. Mean age: 49 years; BMI: 31kg/m2; ESS: 12.7; AHI: 41.1
Inclusion criteria: AHI >10 events/hr
Exclusion criteria: CHF; chronic rhinitis; other sleep disorders
|
|
Study supported by MADELA AG, distributors of Respironics products in Switzerland’.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Patruno 2007193
Randomised, parallel group trial
|
Auto-CPAP versus fixed CPAP
Study duration: 12 weeks
|
N = 31 participants (Auto-CPAP: 15; fixed CPAP: 16). Mean age: 48 years; BMI: 36.5kg/m2; AHI: 47; ESS: 15
Inclusion criteria: AHI > 20; ESS > 12
Exclusion criteria: Not specified
|
|
This work was supported by a University of Milan Fondo Interuniversitario per la Ricerca Scienfifica e Technologia Grant and a Minister for Instruction, University and Research Progetto di Ricerca di Interesse Nazionale 2003 grant to Dr. Montano.
Study included in the Cochrane review.
Severe OSAHS based on mean AHI
|
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Pépin 2016199
Single-centre, randomised controlled, double-blind, parallel group trial
|
Fixed versus auto-adjusting CPAP
Study duration: 4 months
|
N = 322 participants (70% male). Age: 58; BMI: 30kg/m2 AHI: 38.8
Inclusion criteria: age: 18 to 80 years, capable of providing written informed consent, patients claiming social insurance and patients with OSA needing CPAP treatment.
Exclusion criteria: cardiac failure known and treated, central Apnea syndrome, patients who stopped CPAP treatment in the previous year, pregnancy, patients under guardianship, imprisoned patients, patients in hospital, patients included in another clinical study.
|
|
The study was funded by the ‘Fondation Agir pour les maladies chroniques’. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.’
Study included in the Cochrane review.
Severe OSAHS based on mean AHI.
|
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Randerath 2001214
Randomised, cross-over study.
|
Auto-CPAP versus fixed CPAP.
No washout.
Study duration: 2 × 6-week treatment periods 24- hour telephone helpline was at the disposal of the participants.
| N = 52. (45 M/7 F). Mean age: 54.7 years; BMI: 32.4 kg/m2; AHI 35.1
|
|
‘The devices were supplied by the Weinmann Company, Hamburg, Germany.’
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Resta 2004221
Randomised, parallel group trial. Single-blinded study
|
Auto-CPAP versus fixed pressure CPAP. CPAP titration undertaken manually in sleep laboratory
Study duration: 4 weeks
|
N = 20 participants (18 M/2 F). Mean age: 47 years; BMI: 37 kg/m2; ESS: 14
Inclusion criteria: Untreated OSA; PSG-confirmed diagnosis of OSA (ASDA criteria)
Exclusion criteria: Not reported
|
|
Funding information not provided
Study included in the Cochrane review
Mean AHI not available from Cochrane review
|
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Rochford 2006224
Randomised, cross-over study Statistical analysis: information not available
|
Auto-CPAP (Autoset Spirit, ResMed) versus fixed CPAP Auto-CPAP (APAP, Compumedics) versus fixed CPAP
Study duration: 3 × 4-week duration. 2-week washout
|
N = 13 participants. Mean age: 48.2 years; AHI: 22.5; ESS: 11.2
Inclusion criteria: Newly diagnosed OSA patients
Exclusion criteria: Not reported
|
|
Funding information not available (conference abstract).
Study included in the Cochrane review
Moderate OSAHS based on mean AHI
|
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Rohling 2011225
Single-blind, randomised, cross-over trial
|
Pressure restricted auto-adapting CPAP versus fixed CPAP.
Study duration 2 × 12 weeks
|
N = 33 participants. Mean age: 52; BMI: 30.6 kg/m2; AHI: 35; ESS: 7.5
Inclusion Criteria: Age > 18 years, CPAP naive with diagnosis of OSA, understand Dutch language, AHI > 15 events per hour with mild sleepiness or AHI > 5 events/hour with moderate/severe sleepiness.
Exclusion Criteria: Central Sleep Apnoea, Cheyne-Stoke Respiration, severe nasal obstruction, facial/pharyngeal abnormalities, shift work, psychiatric disorder, heart failure, COPD, seizure disorder, pregnancy, learning disability.
|
|
Funding information not available (conference abstract)
Study included in the Cochrane review.
Severe OSAHS based on mean AHI
|
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Rostig 2003228
Randomised, cross-over study.
|
Auto-CPAP (AutoSet T) versus fixed pressure CPAP
Study duration: 2 × 4-week treatment periods
|
N = 30. No baseline details provided.
Participants were on long-term CPAP for OSA, but were using it for less than 4 hours per night.
|
|
Funding information not available (conference abstract).
Study included in the Cochrane review
Mean AHI not available from Cochran review
|
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Senn 2003237
Randomised, cross-over study. Method of randomisation not reported.
|
AutoCPAP (DeVilbiss - response to apnoeas and snoring) & AutoSet T - response to apnoea and snoring + flow limitation) versus fixed pressure CPAP
Study duration: 2-week run-in with either auto-CPAP device. 3 × 4 week treatment periods.
|
N = 31. Withdrawals: N = 2. 23 M/6 F. Mean age: 53 years; BMI: 33.3 kg/m2; AHI: 45.8; ESS: 14.2
Inclusion criteria: AHI > 10 per/hour; CPAP-naive
|
|
‘Supported by the Lung League of Zurich, Lung League of Schaffhausen, Lamprecht AG & Labhardt AG’.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Sériès 1997238
Randomised, single-blind, parallel group study
|
Auto-CPAP 1 (measured effective pressure based upon polysomnography) versus Auto-CPAP 2 (effective pressure estimated by pre-specified formula) versus fixed CPAP.
Data entered from Auto-CPAP 1.
Study duration: 3 weeks
|
N = 36. 12 in each group. No drop-outs. Age range 36 to 65; AHI: 43.6; ESS: 15.5
Inclusion criteria: OSA confirmed by polysomnography and by clinical features; participants chosen to be treated by CPAP
Exclusion criteria: Life threatening OSA (severe hypersomnolence); OSA associated with non-obstructive breathing disorders (narcolepsy); estimated pressure < 15 cm2 H2O. All participants were recruited from the Hôpital Laval sleep clinic
|
|
Funded in part by Pierre Medical France.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Sériès 2001239
Randomised, parallel group trial
|
Auto-CPAP (Morphée) versus fixed CPAP
Study duration: 3 weeks
|
N = 48. 40 had previously participated in other trials of auto and fixed CPAP. Mean age: 48; BMI: 39.5kg/m2
Inclusion criteria: PSG-diagnosed OSA
Exclusion criteria: Corrective surgery for OSA
|
|
Funding information not provided.
Study included in the Cochrane review
Mean AHI not available from Cochrane review
|
|
Teschler 2000253
Randomised, double-blind, crossover study
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Auto-CPAP versus fixed CPAP.
No washout period.
Study duration: 2 × 8-week treatment periods
|
N = 10 participants (10 M). Mean age 52 years; AHI 52.9
Inclusion criteria: > 20 AHI, residence < 50 km from clinic and newly diagnosed with OSA
Exclusion criteria: Co-existing airways disease (asthma/COPD), rhinitis or cardiac failure
|
|
Funding information not provided.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
|
To 2008254
Randomised, crossover study.
|
Auto-CPAP versus fixed CPAP
Study duration: 2 × 8 weeks (washout: 1 week)
|
N = 43 (2 lost to follow up). BMI: 28.7 kg/m2; AHI: 54.3; ESS: 13.4
Inclusion criteria: 18 to 65 years; newly diagnosed OSA (AHI > 30)
Exclusion criteria: prior treatment for OSA
|
|
The authors declared no conflict of interest between ResMed Company and the participating institutions, which received no external funding support for this study.’
Study included in the Cochrane review.
Severe OSAHS based on mean AHI
|
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Vennelle 2010257
Randomised, blinded, cross-over trial.
|
Fixed pressure versus variable pressure CPAP
Study duration: 2 × 6 weeks
|
N=200. (46 F). Mean age 50; BMI 34.5 kg/m2; AHI: 33; ESS 14
Inclusion criteria: ESS > 10 or sleepiness while driving; AHI > 15 on PSG or > 25 apnoeas / hypopneas per hour on limited sleep study; age 18 to 75; CPAP naive.
Exclusion criteria: neurological deficit compromising CPAP use; significant co-morbidity; co-existing narcolepsy / periodic limb movements; contraindication to CPAP
|
|
This study was supported by a grant from ResMed, Poway, CA. Dr. Douglas is a shareholder in ResMed.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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West 2006261
Randomised, parallel group trial.
|
Auto-CPAP versus algorithm established fixed CPAP
Additional treatment group not considered for this review: 1 week auto-titration followed by fixed pressure at the level of 95th centile pressure from the auto-CPAP week data.
Study duration: 24 weeks
|
N = 98. (N considered for this review: 65). Mean age: 47; ESS: 16;
Inclusion criteria: 18 to 75 years of age; ESS > 9; proven OSA (PSG); 10 dips/hr in arterial O2 saturation; CPAP-naive
Exclusion criteria: Respiratory failure requiring urgent treatment; unable to give written consent Participants were not excluded on the basis of co-morbidities
|
|
ResMed UK provided part financial support for the purchase of CPAP machines for the study but was not involved in its design or analysis.
Study included in the Cochrane review
Mean AHI not available from Cochrane review.
|
| Bi-level PAP/Non-invasive ventilation machines with fixed pressure CPAP – 6 studies |
|---|
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Gay 200374
Randomised, double-blind, parallel group trial.
|
Bi-level PAP (non-invasive ventilation) versus CPAP. Participants also given instruction via educational video on CPAP and OSA.
Study duration: 30 days
|
N = 27 participants. Age: 44 years; BMI: 35kg/m2; AHI: 43; ESS: 13.8
Inclusion criteria: > 18 years; AHI > 10 and < 100; ability to follow instructions and provide informed consent; willingness to return for follow-up visit 30 days after random allocation to CPAP/BiPAP (non-invasive ventilation); residence within 200 miles of clinic
Exclusion criteria: inability to wear a mask; prior surgical treatment for OSA; prior CPAP usage; other significant co-morbidities
|
|
Dr. Peter Gay received grant support for this study by Respironics Inc. (noted in manuscript).’
Study included in the Cochrane review
Severe OSAHS based on mean AHI
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Gonzalez-Moro 200577
Randomised parallel group study.
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BiPAP (non-invasive ventilation) versus fixed pressure CPAP
Study duration: 12 weeks
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N = 20; ESS: 12. No other baseline details provided
Inclusion criteria: OSA and obstructive hyperventilation syndrome
Exclusion criteria: Not reported
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Funding information not available (conference abstract)
Unpublished conference abstract.
Study included in the Cochrane review
Mean AHI not available from Cochrane review
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Gulati 201581
Prospective, randomized, crossover study in patients who were sub optimally compliant with CPAP despite appropriate interventions
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BiPAP (non-invasive ventilation) vs new CPAP (brand of fixed CPAP different from the one used prior to study entry)
Study duration: 2 × 4 weeks with 2 weeks washout in-between
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N = 28 participants (24M/4F). Mean Age 56.7 years; BMI 35 kg/m2; ESS 13.2; AHI 35
Inclusion criteria: OSA with AHI > 5, CPAP compliance < 4 hours per night for 6 weeks after CPAP prescription despite technical and educational interventions, symptoms of pressure intolerance.
Exclusion criteria: Significant airflow obstruction (FEV1/FVC < 60%), pre-treatment study showing central sleep apnoea, clinical evidence of congestive heart failure, daytime hypercapnia (PaCO2 > 6.5kPa) or previous prescription of BiPAP.
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Funding source: not declared.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
|
Masa 2015137
Randomised, three-arm, parallel group
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Fixed CPAP versus Non-invasive ventilation treatment set at bilevel pressure with assured volume. Study assigned to Bi-level PAP comparison. Supplemental oxygen offered if participants met additional criteria (daytime PaO2 < 55 mm Hg, with the necessary flow to maintain waking arterial oxygen saturation between 88 and 92% or PaO2 greater than or equal to 55 mm Hg for at least 17 h/d).
Third treatment arm consisting of a usual care control was not of interest to this review.
Study duration: 3 years (for hospitalisation & withdrawal outcomes). Other outcome data reported at 8 weeks unless stated.
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N = 151 participants (entered in to treatment groups relevant to this review question). 66m/ 85f Age: 60 years; BMI: 44 kg/m2; AHI: 69; ESS: 11.
Inclusion criteria: 15-80 years; AHI: >30; no other significant sleep disorders (e.g. narcolepsy or restless leg syndrome); correctly executed 30-minute CPAP/NIV test
Exclusion criteria: Significant comorbidity
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Supported by the Instituto de Salud Carlos III (Fondo de Investigaciones Sanitarias, Ministerio de Sanidad y Consumo) grant PI050402, the Spanish Respiratory Foundation 2005 (FEPAR), and Air Liquide Spain’. Funders did not participate in the design or conduct of the study, analysis or interpretation of data, or manuscript preparation.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Muir 1998161
Randomised, double-blind, crossover study.
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Bi-level PAP (non-invasive ventilation) versus fixed CPAP
Study duration: 2 × 8-week treatment periods
Pressure levels for inspiratory pressure were: 12.3 cm H2O (SD 1.8), and expiratory pressure: 7.6 cm H2O (SD 2.2) for bilevel PAP treatment, and for fixed CPAP: 9.4 cm H2O (SD 2.3) (no P value reported)
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N = 16 participants. Mean age: 59 years; BMI: 31kg/m2; AHI: 69
Inclusion criteria: previously documented OSA and poor compliance with CPAP (< 3 hours per night)
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Machine usage Adverse events
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Funding information not available (conference abstract)
Study published as conference abstract.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Reeves-Hoché 1995219
Randomised, parallel group trial
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Bi-level Positive Airways Pressure (non-invasive ventilation) versus Continuous Positive Airways Pressure administered at home
Study duration: 52 weeks Prescribed inspiratory pressure was 11 mmHg ± 0.3 and expiratory pressure was 7 mmHg ± 0.3 in the BiPAP group versus 10 mm Hg ± 0.2 in the fixed CPAP group at baseline
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N = 83, 17 Females (out of 62 completers). Mean age: 47; BMI: 40kg/m2; AHI: 51
Inclusion criteria: OSA diagnosed according to American Sleep Disorders Association AHI >10; “heavy snoring”; excessive daytime sleepiness
Exclusion criteria: Concomitant illness requiring hospitalisation 6 months previously; psychiatric illness; pregnancy.
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Supported in part by Respironics’.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
| humidification to fixed level CPAP |
|---|
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Heiser 201084
Randomised, parallel group study
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CPAP with warm air humidifier versus CPAP without warm air humidifier
Study duration: 12 weeks
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N = 74 participants (M/F 60/14). Mean age 58 years; BMI 31 kg/m2; AHI 35; ESS 9
Inclusion criteria: Newly diagnosed OSA patients (AHI > 15 on polysomnography).
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Funding source: Study was funded by manufacturers (‘Diese Studie wurde finanziell unterstützt durch die Firmen Fisher & Paykel Healthcare und Air Products Medical GmbH.)
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
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Neill 2003180
Randomised, double-blind, crossover study.
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Humidification in addition to nasal CPAP versus sham humidifier in addition to nasal CPAP
Study duration: 2 × 3-week treatment periods (3 day washout)
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N = 42 randomised (37 completed study protocol and were analysed). Mean age: 49 years. BMI: 35kg/m2; RDI: 50; ESS: 12.1
Inclusion criteria: Newly diagnosed OSA requiring treatment with CPAP
Exclusion criteria: Significant nasal obstruction; requirement for supplemental oxygen
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|
This study was funded by an Otago University Research Grant.’
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
|
Worsnop 2010267
Randomised, parallel group study
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Fixed pressure CPAP + humidification versus fixed pressure CPAP alone
Study duration: 12 weeks
|
N = 54 participants. Mean age 55 years; AHI 46. ESS 14
Consecutive OSA patients referred for CPAP, under a program paid for by the Victorian State government, were enrolled.
|
|
Fisher and Paykel Healthcare, Auckland, New Zealand funded this study.
Study included in the Cochrane review.
Severe OSAHS based on mean AHI
|
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Ruhle 2011230
Randomised, cross-over study
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CPAP with heated humidification versus CPAP without heated humidification
Study duration: 2 × 4 weeks
|
N = 51 participants. Age 51.5; BMI: 30.9 kg/m2; AHI: 43; ESS 10.3
Inclusion criteria: all patients referred with OSA, aged between 30 and 80 and without nasal or throat complaints
Exclusion criteria: >5 central apneas per hour of sleep, acute infection, NYHA III or IV heart failure, acute pulmonary embolism or acute coronary syndrome. Previous use of CPAP
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K-H. Ruhle and G. Nilius received research funding from Fisher & Paykel Healthcare, Heinen und Löwenstein, ResMed and Weinmann. The author’s study was supported by a grant from Fisher & Paykel Healthcare Germany GmbH & Co. KG, 73636 Welzheim, Germany. with this investigation.’
Study included in the Cochrane review.
Severe OSAHS based on mean AHI.
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Ryan 2009231
Randomised, parallel group trial
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Standard (dry) CPAP versus CPAP with heated humidification versus CPAP with nasal steroid spray
Study duration: 4 weeks
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N = 125 participants consecutively recruited from Respiratory Sleep Disorders Unit. Age: 48; BMI: 35 kg/m2; AHI: 36; ESS: 12.5
Inclusion criteria: AHI > 10, CPAP naive, successful nasal CPAP titration study, adequate nasal breathing.
Exclusion criteria: BiPAP or supplemental oxygen; malignant disease; psychiatric disease; regular use of narcotics; sedatives or psychoactive substances.
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‘This was not an industry supported study.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
|
|
Soudorn 2016246
Prospective, single blinded, randomised, crossover study in climate with a high humidity level
|
CPAP with heated humidification versus conventional CPAP alone
Study duration: 2 × 4 weeks
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N = 20. (M/F 14/6). Mean age 48.9 years; BMI 28.1 kg/m2; AHI 53.7; ESS 11.5
Inclusion criteria: Age > 18 years; AHI > 15 on split-night polysomnogarphy; nasopharyngeal symptoms according to modified XERO questionnaire.
Exclusion Criteria: > 5 central apnoeas per hour; acute infection; heart failure with NYHA class 3 or 4; acute pulmonary embolus; acute coronary syndrome; travel outside of Thailand within 2 months of study baseline pattern of split-night PSG < 2 hours, less than optimal CPAP titration, use of humidification during split-night study
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‘This work was supported by the Ratchadaphiseksomphot Endowment Fund of Chulalongkorn University. All CPAP machines and related equipment were sponsored by Fisher and Paykel Healthcare Limited.
Study included in the Cochrane review
Severe OSAHS based on mean AHI
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