1. When to suspect

1.3. PICO table

For full details see the review protocol in appendix A.

Table 1

PICO characteristics of review question.

1.4. Clinical evidence

1.4.1. Included studies

OSAHS

A search was conducted for cohort studies investigating the association of the following factors: snoring, witnessed apnoea, unrefreshing sleep, somnolence during waking hours, nocturia, tiredness, insomnia, headaches, sleep fragmentation, ankle swelling, unexplained elevated Hb, cognitive dysfunction/memory impairment, co-existing conditions, treatment resistant hypertension, nocturnal non-dipping hypertension, treatment resistant arrhythmias, atrial fibrillation, type 2 diabetes, diabetic macular oedema, aortic aneurysms, chronic heart failure, cardiovascular events, stroke, Down’s syndrome, acromegaly and BMI over 30 kg/m² with suspected OSAHS.

Seventeen studies were included in the review:^{15, 22, 45, 69, 74, 88, 104, 113, 114, 179, 182, 201, 216, 222, 224, 229, 250}

Evidence from these studies is summarised in the clinical evidence summary below.

The included studies investigated the effects of following risk factors: non-arteritic anterior ischaemic optic neuropathy (NAION) (sudden loss of vision in one eye due to decreased blood flow to the optic nerve), polycystic ovary syndrome (PCOS), bipolar disorder, essential hypertension, end-stage renal disease (ESRD), acute cerebral infarction (ACI) and transient ischemic attack (TIA), asthma, severe aortic stenosis (AS), thoracic aortic aneurysm (TAA), obesity, asthma, type 2 diabetes, mild cognitive impairment (MCI), Down’s syndrome (DS), type 1 diabetes and primary headache disorders (PHD).

Some risk factors such as non-arteritic anterior ischaemic optic neuropathy (NAION), polycystic ovary syndrome (PCOS), bipolar disorder, end-stage renal disease (ESRD) were not specified in the protocol but were included as the committee considered these were risk factors to be associated with high risk for OSAHS.

No relevant clinical studies investigating the effects of snoring, witnessed apnoea, unrefreshing sleep, somnolence during waking hours, nocturia, tiredness, insomnia, sleep fragmentation, ankle swelling, unexplained elevated Hb, treatment resistant arrhythmias, atrial fibrillation, diabetic macular oedema, aortic aneurysms, chronic heart failure, acromegaly on risk of OSA were identified.

All studies were conducted in secondary care.

Only 3 studies matched controls for all key confounders (age, sex, BMI, co-morbidities) and the rest of the studies adjusted for 2 or 3 confounders.

Most studies reported incidence/prevalence of OSAHS as the outcome; however, a few studies reported AHI which was also considered as an association outcome.

Some studies reported results as adjusted odds ratio/hazards ratio for the outcomes, and these have been reported as in the studies. Some studies had matched controls but did not report adjusted measures of effect in such cases data has been analysed using prevalence/incidence data of OSAHS reported in the studies.

OHS

No studies were identified assessing the risk of OHS.

COPD-OSAHS overlap syndrome

No studies were identified assessing the risk of COPD-OSAHS overlap syndrome.

See also the study selection flow chart in Appendix C, study evidence tables in Appendix D, forest plots in Appendix E and GRADE tables in Appendix F.

1.4.1.1. Excluded studies

See the excluded studies list in Appendix D.

1.4.2. Summary of clinical studies included in the evidence review

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Study	Risk factor	Population	Outcomes	Comments
Arda 201315 Turkey Prospective cohort study	Non-arteritic anterior ischaemic optic neuropathy (NAION).	N= 20 patients with a newly diagnosed NAION were included in this study. N= 20 age and sex matched subjects with similar risk factors for NAION, such as DM and HT, constituted the control group.	Diagnosis of sleep apnoea	The aim of this study was to show the prevalence of obstructive sleep apnoea (OSA) in non-arteritic anterior ischaemic optic neuropathy (NAION). Controls matched for age and sex. Not matched for BMI and co-morbidities. Duration of study- 4 years
Balachandran 201922 UK Population-based retrospective cohort study	Polycystic ovary syndrome (PCOS).	N= 76 978 women with PCOS and N=143 077 matched control women without PCOS. Matched for age-, BMI- and location. Inclusion criteria: All women who were aged 18–50 years at the index date (study entry) and had a documentation of PCOS at any time during the study period were included in the exposed group. Patients with any documentation of OSA prior to the index date were excluded. Women without documented PCOS at any time during the study period were included in the unexposed (control) arm. The index date was defined as the date of first documentation of PCOS for newly diagnosed cases and from the date patient became eligible if the first documentation of PCOS was prior to the eligibility date Each exposed patient was randomly matched to two unexposed patients (1:2 ratio) for general practice, age at index date and BMI	Incidence of OSA	Objective was to assess the risk of OSA in women with vs without PCOS Controls matched for age at index date and BMI Duration of study- 7 years
Chang 201945 Taiwan Prospective cohort study	Bipolar disorder	N=3650 patients with bipolar disorder and who had no history of OSA prior to enrolment Only patients who were prescribed lithium, valproate, carbamazepine, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone for at least 28 cumulative days after the date of BD diagnosis were included in the BD cohort. N=18250 without bipolar disorder matched by sex and age	Incidence of OSA follow-up 7.49 years	Matched by age and sex Participants enrolled between 2000 and 2010 and followed until end of 2013
Fletcher 198569 USA Prospective cohort study	Essential hypertension	N=46 hypertensive men N=34 normotensive men	Apnoea index Hypopnoea index	Matched only for age and weight Duration of study-NR
Gaisl 202074 Prospective cohort study Switzerland	Patients with thoracic aortic aneurysm (TAA).	N=208 TAA N=104 control Patients with TAA were recruited from an ongoing cohort study. Matched controls were recruited form the outpatient clinic of the University Hospital Zurich between Jan and November 2018 82% male; age: 62 (11) years; BMI 27 (4) Kg/m2	Prevalence of OSA	Confounding variables: Age, sex, height, weight and left ventricular ejection fraction Duration of study-NR
Hachul 201988 Prospective cohort study Brazil	Women with polycystic ovary syndrome (PCOS).	N=30 PCOS N=14 healthy control A total of 55 subjects were selected to participate in the study. The volunteers, ranging in age from 16 to 45 years, were recruited from the Endocrinology Division of the Federal University of São Paulo, Brazil.11 individuals were excluded because of missing data (8 related to the PSQI and 3 to BMI).	High risk of OSA	Confounding variables: Age, BMI Duration of study-NR
Huang 2018104	end-stage renal disease (ESRD)	Dialysis patients. 90,353 patients with newly diagnosed ESRD from 1 January 2000 to 31 December 2011. After excluding patients who were under 20 years of age, and those who had an OSA history), kidney transplantation, or a follow-up period of less than 90 days, 88,801 ESRD patients were enrolled, including 78,814 HD and 9987 PD (including continuous ambulatory peritoneal dialysis and automated peritoneal dialysis) patients. Next haemodialysis (HD) with peritoneal dialysis (PD) patients were matched by age and sex in a 2:1 ratio and generated an ESRD cohort including a HD cohort consisting of 19,574 patients and a PD cohort with 9987 patients. 118,244 individuals were selected in the database who did not have a history of CKD or ESRD as the non-ESRD control cohort matched with the ESRD cohort by age, sex, and index-year in a 1:4 ratio. Men: control 55,092 (46.6 %); total ESRD 13,773 (46.6%) Mean age (SD): control- 54.0 (14.9); 54.1 (14.8)	Risk of OSA	Confounding variables: age, sex, and index-year. Duration: Between 2010 and 2011
Joo 2011113 Korea Prospective cohort study	acute cerebral infarction (ACI) and transient ischemic attack (TIA)	N=61 patients with acute cerebral infarction (ACI) N=13 patients with transient ischemic attack (TIA); N= 64 control Consecutive patients (aged 45 to 80 years) admitted to the Department of Neurology at the Korea University Medical Center for an ACI or transient ischemic attacks (TIA), with 48 h of onset, were enrolled in the present study. Patients with any of the following were excluded: (1) a decreased level of consciousness on admission; (2) a seizure at stroke onset; (3) a baseline oxygen saturation of <95%; (4) chronic obstructive pulmonary disease; (5) a neuromuscular junction disorder (e.g., myasthenia gravis); or (6) a neurodegenerative disorder, such as, Parkinson’s disease, progressive supra nuclear palsy, or Alzheimer’s disease. Age-matched patient’s spouses or family members with no history of physician diagnosed stroke were enrolled as controls	Prevalence of sleep disordered breathing	Controls matched for age- not matched for all sex, BMI and co-morbidities. SDB at 48 h following ACI or TIA
Julien 2009114 Canada Prospective cohort study	Asthma	N= 26 patients with severe asthma consecutively recruited to a difficult asthma program N= 26 patients with moderate asthma, N= 26 controls without asthma of similar age and body mass index. Subjects with asthma were recruited from the Difficult Asthma Programme.2 Recruitment to the programme was solely on the basis of asthma history. Severe asthma was defined according to American Thoracic Society criteria1 and required at least 1 major criterion: daily oral steroids for >50% of the previous 12 months, or high-dose inhaled steroid: fluticasone 1000 mg/d or equivalent, and at least 1 other add-on therapy continuously for 12 months; and 2 minor criteria: daily short-acting b-agonist persistent FEV1 <70% and FEV1/forced vital capacity <80% predicted, urgent visits or steroid bursts in the last 12 months, prompt deterioration with <25% steroid dose reduction, or previous near-fatal asthma within 3 years. Moderate asthma was defined as well controlled asthma symptoms (Juniper asthma control score13 <1), use of long acting b-agonist and fluticasone (or equivalent) 200 mg/d and 1000 mg/d, 2 steroid bursts in the past year and none within 3 months, total days on oral steroids <30 in the previous 12 months, FEV1 >70% predicted, and 1 unscheduled clinical visit in the previous 12 months. Exclusion criteria for both groups included current smoking and other conditions which could lead to cardiorespiratory symptomatology. No sleep related information was obtained from subjects before recruitment into the Difficult Asthma Program or the current study. Consecutive patients enrolled in the program were approached to participate in this study. Of the patients approached during the recruitment period, 26 of 27 patients with severe asthma and 26 of 31 patients with moderate asthma consented to participate. Control subjects were recruited through community advertisements, which referred to a clinical study on ‘‘breathing patterns and asthma.’’ Subjects were required to be generally healthy, to be non- smoking for at least 1 year, and to have no previous history of asthma, respiratory problems, or prescription of inhalers. No sleep-related information was used in the recruitment or screening process. Potential recruits meeting eligibility criteria were included based on age, body mass index (BMI), and sex to match the asthmatic groups. Epworth sleepiness scores were obtained only after informed consent.	Prevalence of OSA	Control group matched for age, BMI and sex Duration of study-NR
Prinz 2011179 Germany Prospective cohort study	Severe aortic stenosis (AS).	N=67 Severe aortic stenosis (AS). N=42 consecutive patients (19 male; mean age 72 years), who came for further evaluation of isolated severe aortic stenosis (aortic valve opening area #1.0 cm2); all patients with diabetes mellitus and concomitant pulmonary disease, particularly those with forced expiratory volume in 1s <50%, were excluded. Further exclusion criteria included a diagnosis of acute coronary syndrome or change of stable medication within the preceding 2 weeks. All patients had standard preoperative diagnostics, including echocardiography and left and right heart catheterisation. Right heart catheterisation was carried out to assess mean pulmonary artery pressure (mPAP) and pulmonary capillary wedge pressure (PCWP).13 In-hospital unattended cardiorespiratory polygraphy was performed after informed consent had been obtained from each patient before participation. Control group N=25 patients (14 male; 70 years), who had cardiac catheterisation based on a pathological stress test and individual risk stratification. Coronary artery disease was angiographically excluded in each of these patients. The entire control group had preserved left ventricular ejection fraction (>55%) and no valve disease. The control group was matched for age, gender and body mass index (BMI).	Prevalence of sleep apnoea	Study objective to assess the occurrence, severity and clinical correlates of sleep apnoea in patients with AS. Control group was matched for age, gender and body mass index (BMI). Not matched for co-morbidities. Study period: 4 months
Subramanian 2019216 Retrospective cohort study UK	Type 2 diabetes	N= 360,250 exposed cohorts N=1,296,489 unexposed patient cohorts Adult patients aged 16 years and above registered for at least 12 months with any of the eligible general practices prior to study entry formed the source population. The exposed cohort consisted of adult patients with type 2 diabetes. Type 2 diabetes diagnosis was ascertained by the presence of any type 2 diabetes clinical code in the patient’s medical record and the absence of any record of type 1 diabetes. The Read code list used to define exposure has previously been used to study type 2 diabetes. Unexposed cohort For every exposed patient, up to 4 controls were randomly selected from an age-, sex- and BMI-matched pool of eligible patients without a record of type 2 diabetes at any time point before or during the study period. Age and BMI were matched to within 1 year and 2 kg/m2 respectively. Patients with a prevalent OSA diagnosis were excluded. The study cohort was derived from The Health Improvement Network (THIN), a UK primary care database, from 01/01/2005 to 31/12/2017.	Incidence of OSA	Objective to compare incidence of OSA in patients with and without type 2 diabetes and to investigate risk factors for OSA in patients with type 2 diabetes. Follow-up period- 15 months. Control group matched for age, sex and BMI.
Rice 2015182 USA prospective cohort study	Obesity	N=573 lean women (BMI of less than 25 kg/m2) N=459 obese women (BMI total of 1032 pregnant women between the ages of 18 and 45 years (mean age = 28.6 years, standard deviation = 6.2 years) participated in the study. This study was conducted among pregnant women attending prenatal care clinics at the Instituto Nacional Materno Perinatal (INMP) in the city of Lima, Peru between February 2013 and March 2014. Eligible women were 18 years of age or older, could speak and read Spanish, and with a gestational age between 24 to 28 weeks. Women were weighed in light clothing using the WHO standard guidelines.	High risk for OSA	Analysis adjusted for maternal age, education, marital status and parity. Adjusted odds ratio reported. Duration of study-2013-2014
Shen 2015201 Taiwan retrospective cohort study	Asthma	N = 155347 without asthma N = 38840 with asthma Patients above 20 years, who had been diagnosed with asthma, as the asthma cohort. Exclusion criteria included those diagnosed before index date, and with incomplete gender or age information. The index date was defined as the date of asthma diagnosis. The comparison cohort was randomly selected from all NHI beneficiaries, no asthma, above 20 years, and were frequency-matched for gender, age (every five years), and Index year with a 1:4 ratio. The diagnosis of asthma was made based on a target history, and a comprehensive pulmonary function evaluation.	Incidence of OSA	Model adjusted for age, sex and comorbidities of hypertension, diabetes, hyperlipidaemia, COPD, CAD, stroke, rhinitis, chronic sinusitis, GERD and obesity. The mean follow-up period was 6.95 years (SD = 3.33) for the asthma cohort, and 6.51 years (SD = 3.44) for the comparison cohort.
Terpening 2015222 Australia Prospective cohort study	Mild cognitive impairment (MCI)	N=46 patients with MCI N=40 age matched controls	Sleep disordered breathing	Control group matched for age Duration of study-NR
Trois 2009224 USA Retrospective cohort study	Down’s syndrome (DS)	N= 16 with Down’s syndrome (DS) N= 48 without Down’s syndrome (DS). 16 adults with DS underwent evaluation for sleep disordered breathing. Interventions: Polysomnographic results were compared to a retrospective sample of adult patients referred for clinically suspected OSAS.	Diagnosis of sleep apnoea	Controls matched for age, sex and BMI Duration of study-NR
Van dijk 2011229 The Netherlands Retrospective cohort study	type 1 diabetes	N= 99 adult patients with type 1 diabetes (55 men, 44 women, duration of diabetes 26.9±1.2 years) N= 99 age-, sex- and BMI-matched non-diabetic controls. 99 consecutive patients with type 1 diabetes mellitus (55 men, 44 women) attending the outpatient clinic of the Leiden University Medical Center, and 99 age-, sex- and BMI-matched non-diabetic controls recruited by advertisement. Every patient with type 1 diabetes was individually matched with one non-diabetic healthy control for age, sex and BMI	High risk OSA	Matched for age, sex and BMI. Duration of study-NR
Yin 2019250 Taiwan Retrospective cohort study	Primary headache disorders (PHD)	N=1346 Primary headache disorders (PHD) cohort N=5384 Comparison cohort. All patients in longitudinal health insurance database (LHID) who were diagnosed for PHDs for the first time from 2000 to 2005 were identified according to the International Classification of Headache Disorders, Second Edition criteria (N=1346). Patients diagnosed of PHDs before 2000 were excluded to increase the likelihood of identifying new cases. From the beginning of 2000 to the end of 2005 during which a patient was first diagnosed with PHDs was set as the index date. randomly selected 5384 subjects (a sample size fourfold that of the PHDs group) from LHID, frequency matched with the study cohort in terms of age, sex, index date and comorbidities (chronic obstructive pulmonary disease [COPD], hypertension, diabetes, hyperlipidaemia, stroke, obesity and depression). Each patient was then followed up from the index date until the occurrence of SA.	Incidence of OSA	Adjusted for confounding variables: age, sex, index date and comorbidities (chronic obstructive pulmonary disease [COPD], hypertension, diabetes, hyperlipidaemia, stroke, obesity and depression). Duration of study-NR

1.4.3. Quality assessment of clinical studies included in the evidence review

Table 2

Clinical evidence summary: People with primary headache disorder vs control.

Table 3

Clinical evidence summary: People with asthma vs control.

Table 4

Clinical evidence summary: People with moderate asthma vs People without asthma.

Table 5

Clinical evidence summary: People with severe asthma vs People without asthma.

Table 6

Clinical evidence summary: People with bipolar disorder vs control.

Table 7

Clinical evidence summary: People with hypertension (essential hypertension) vs control.

Table 8

Clinical evidence summary: People with type I diabetes vs control.

Table 9

Clinical evidence summary: People with non-arteritic anterior ischaemic optic neuropathy (NAION) vs control.

Table 10

Clinical evidence summary: People with PCOS vs people without PCOS.

Table 11

Clinical evidence summary: obese pregnant women vs lean pregnant women.

Table 12

Clinical evidence summary: overweight pregnant women vs lean pregnant women.

Table 13

Clinical evidence summary: People with acute cerebral infarction vs control.

Table 14

Clinical evidence summary: People with transient ischaemic attack vs control.

Table 15

Clinical evidence summary: People with mild cognitive impairment vs control.

Table 16

Clinical evidence summary: People with severe aortic stenosis vs control.

Table 17

Clinical evidence summary: People with Down’s syndrome vs control.

Table 18

Clinical evidence summary: People with type 2 diabetes vs without type 2 diabetes.

Table 19

Clinical evidence summary: People with end stage renal disease (ESRD) haemodialysis and peritoneal dialysis vs control.

Table 20

Clinical evidence summary: People with thoracic aortic aneurysm vs matched control.

See Appendix F for full GRADE tables.

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Appendices

Final

Diagnostic association/prediction evidence review

Developed by the National Guideline Centre, hosted by the Royal College of Physicians

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.

Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.