Characteristics of included studies
| Study | Study design and level 3 device used | Patient population | Outcome measures | ||
|---|---|---|---|---|---|
| Patient characteristics | Eligibility criteria | ||||
| Inclusions | Exclusions | ||||
| Combination studies (simultaneous and separate) | |||||
| Abraham et al. (46) | Design: cohort Location: USA/UK No. of sites: 4 Device: ClearPath Nx-301 Channels: 3 | No. of patients: 50 Sex: 34 M, 16 F Mean age: 55.5 ± 12.8 (range 23–78) yr Mean BMI: 32.6 ± 6.5 (range 19–48) Mean ESS: 10.6 ± 4.4 (1–23) Comorbidities: heart failure (LVEF ≤ 35%) | Stable New York Heart Association class III heart failure | Presence of cerebrovascular, neurovascular or terminal disease; severe COPD; known dermatologic condition or allergy to sensors or medical adhesives; documented MI within 6 wk of study | Diagnostic accuracy, adverse events, technical failures |
| Ayappa et al. (47) | Design: cohort Location: USA No. of sites: 1 Device: ARES Channels: 4 | No. of patients: 102 (80 patients, 22 controls)* Sex: 69 M, 28 F Mean age: 44 (range 19–74) yr Comorbidities: NR Mean BMI: 28.7 (range 19–70) Mean ESS: 8.7 | Suspected SDB, healthy volunteers for control | Inability to read English, inability to wear level 3 device on forehead | Diagnostic accuracy, diagnostic agreement, adverse events, technical failures |
| Garcia-Diaz et al. (48) | Design: cohort Location: Spain No. of sites: 1 Device: Apnoescreen II Channels: 4 | No. of patients: 65* Sex: 54 M, 8 F Mean age: 54 ± 10.4 yr Comorbidities: hypertension (27), cardiovascular comorbidity (9) Mean BMI: 30.1 ± 3.9 Mean ESS: 12 ± 3.7 | NR | Physical or mental impairment | Diagnostic accuracy, diagnostic agreement, adverse events, technical failures |
| Kuna et al. (49) (Abstract) | Design: cohort Location: USA No. of sites: 1 Device: Stardust II Channels: 4 | No. of patients: 39 Sex: M Mean age: 54.0 ± 9.6 yr Comorbidities: NR Mean BMI: 35.8 ± 7.0 Mean ESS: NR | Suspected sleep apnea | NR | Diagnostic accuracy, diagnostic agreement |
| Kushida et al. (50) (Abstract) | Design: cohort Location: USA No. of sites: 1 Device: PMP-300E Channels: 4 | No. of patients: 11 Sex: 7 M, 4 F Mean age: 42.1 yr Comorbidities: NR Mean BMI: 26.1 Mean ESS: 8.1 | Age ≥ 18 yr, suspected OSA | NR | Diagnostic agreement |
| Polese et al. (51) (Abstract) | Design: cohort Location: Brazil No. of sites: 1 Device: Stardust II Channels: 4 | No. of patients: 43 Sex: 19 M, 24 F Mean age: mean: 70 ± 5 yr Comorbidities: NR Mean BMI: 30 ± 6 Mean ESS: 9 ± 7 | Age ≥ 65 yr, suspected OSA | NR | Diagnostic accuracy, diagnostic agreement |
| Santos-Silva et al. (52) | Design: cohort Location: Brazil No. of sites: 1 Device: Stardust II Channels: 4 | No. of patients: 82* Sex: 46 M, 34 F Mean age: 47 ± 14 yr Comorbidities: NR Mean BMI: 28 ± 5 Mean ESS: 10.4 ± 5.8 | Age ≥ 21 yr, suspected OSA, ability to provide consent | Suspected other SDB, severe or unstable comorbid conditions, receiving oxygen or mechanical ventilation, neurologic disorders, sedative or hypnotic | Diagnostic accuracy, diagnostic agreement, adverse events, technical failures |
| Smith et al. (53) | Design: cohort Location: UK No. of sites: 1 Device: Embletta Channels: 4 | No. of patients: 20 Sex: 14 M, 6 F Mean age: 61 ± 10 Comorbidities: congestive heart failure Mean BMI: 29 ± 6 Mean ESS: 8 ± 4 | Informed consent, congestive heart failure, age 18–80 yr | None | Diagnostic accuracy, diagnostic agreement, technical failures |
| Tiihonen et al. (54) | Design: cohort Location: Finland No. of sites: 1 Device: “novel device” Channels: 8 | No. of patients: 19 Sex: 11 M, 8 F Mean age: 46.8 ± 12.7 yr Mean BMI: 31.4 ± 10.3 Comorbidities: NR Mean ESS: NR | Suspected OSAS | NR | Diagnostic agreement |
| Tonelli de Oliveria et al. (55) | Design: cohort Location: Brazil No. of sites: 1 Device: Somnocheck Channels: 4 | No. of patients: 157* Sex: 111 M, 38 F Mean age: 45 ± 12 yr Comorbidities: hypertension Mean BMI: 29.2± 5.5 Mean ESS: 11 ± 5 | Age > 18 yr | Pregnancy, severe comorbidity (cancer, heart failure, etc.), difficulties that would interfere with examinations, residence outside hospital catchment area | Diagnostic accuracy, technical failures |
| Simultaneous studies | |||||
| Amir et al. (56) | Design: cohort Location: USA No. of sites: 1 Device: Morpheus Channels: 4 | No. of patients: 55* Sex: 36 M, 17 F Mean age: 47.8 ± 11.3 yr Comorbidities: NR Mean BMI: 32.04 ± 7.9 (median 30.6) Mean ESS: NR | Age 21–80 yr | Pacemaker, COPD, and inability to undergo the test | Diagnostic accuracy |
| Bajwa et al. (57) (Abstract) | Design: cohort Location: USA No. of sites: 1 Device: Alice PDx Channels: 4 | No. of patients: 7 Sex: NR Mean age: NR Comorbidities: NR Mean BMI: NR Mean ESS: NR | NR | NR | Diagnostic agreement |
| Candela et al. (58) | Design: cohort Location: Spain No. of sites: 1 Device: BITMED NGP140 Channels: 4 | No. of patients: 103* Sex: 72 M, 20 F Mean age: 52.4 ± 11.8 yr Comorbidities: hypertension (37), COPD (8), observed apnea (78), excessive daytime sleepiness (70) Mean BMI: 31.8 ± 6.6 Mean ESS: 11.2 ± 4.8 | Suspected SDB | NR | Diagnostic accuracy, diagnostic agreement, technical failures |
| Cheliout-Heraut et al. (59) | Design: cohort Location: France/Belgium No. of sites: NR Device: Somnolter Channels: 5 | No. of patients: 104* Sex: 60 M, 30 F Mean age: 55.4 ± 8.7 (47–70) yr Comorbidities: NR Mean BMI: 26.7 ± 7.3 (mild OSA), 28.9 ± 5.3 (moderate OSA), 29.7 ± 4.1 (severe OSA) Mean ESS: NR | NR | Neurologic disorders, nocturnal parasomnias, restless leg syndrome and periodic limb movement | Diagnostic accuracy, technical failures |
| Divo et al. (60) | Design: cohort Location: Germany No. of sites: 1 Device: Apneagraph Channels: 4 | No. of patients: 14 Sex: 12 M, 2 F Mean age: 52.7 ± 14.3 yr Comorbidities: NR Mean BMI: NR Mean ESS: NR | NR | NR | Sleep indices |
| Driver et al. (61) | Design: cohort Location: Canada No. of sites: 1 Device: MediByte Channels: 4 | No. of patients: 80* Sex: 30 M, 43 F Mean age: mean: 53 ± 12 yr Comorbidities: NR Mean BMI: 32.2 ± 6.8 Mean ESS: NR | Patients with high care needs, known hypercapnia and known hypoventillation | None | Diagnostic accuracy, technical failures |
| Ferre et al. (62) (Abstract) | Design: cohort Location: Spain No. of sites: 1 Device: Somté Channels: 4 | No. of patients: 37 Sex: 24 M, 13 F Mean age: 55.1 ± 11.5 yr Comorbidities: NR Mean BMI: 27.3 ± 3.9 Mean ESS: 10 ± 8.0 | Suspected SDB | NR | Diagnostic accuracy, diagnostic agreement |
| Goodrich et al. (63) | Design: cohort Location: USA No. of sites:1 Device: LifeShirt Channels: 4 | No. of patients: 50* Sex: 35 M, 13 F Mean age: 44 (22–69) yr Comorbidities: NR Mean BMI: NR Mean ESS: NR | Symptoms suggestive of OSA | COPD, neurologic and psychiatric disorders and significant medical conditions | Diagnostic accuracy, diagnostic agreement, technical failures |
| Grant et al. (64) (Abstract) | Design: cohort Location: USA No. of sites: 1 Device: Embletta Channels: 3 | No. of patients: 95 Sex: NR Mean age: NR Comorbidities: NR Mean BMI: NR Mean ESS: NR | NR | NR | Diagnostic accuracy, diagnostic agreement |
| Ng et al. (65) | Design: cohort Location: Hong Kong No. of sites: 1 Device: Embletta Channels: 3 | No. of patients: 90* Sex: 63 M, 17 F Mean age: 51.4 ±11.9 yr Comorbidities: NR Mean BMI: 27.1 ± 4.2 Mean ESS: 9.7 ± 5.3 | Suspected OSAS, self-reported daytime sleepiness interfering with function, and 2 of the following: choking during sleep, gasping during sleep, recurrent awakenings from sleep, unrefreshed after sleep | None | Diagnostic accuracy, diagnostic agreement, technical failures |
| Ng et al. (66) | Design: cohort Location: Hong Kong No. of sites: 1 Device: ApneaLink Channels: 3 | No. of patients: 50 Sex: 44 M, 6 F Mean age: 50 ± 11.8 yr Comorbidities: NR Mean BMI: 27.9 ± 4.8 Mean ESS: 10.1 ± 5.5 | Daytime sleepiness, choking, unrestful sleep, fatigue, recurrent awakening from sleep and impaired concentration | None | Diagnostic accuracy, diagnostic agreement, technical failures |
| Nigro et al. (67) | Design: cohort Location: Argentina No. of sites: 1 Device: ApneaLink Channels: 3 | No. of patients: 76* Sex: 47 M, 19 F Mean age: 51.5 ± 14.1 yr Comorbidities: NR Mean BMI: 29.3 ± 5.4 Mean ESS: NR | Suspicion of sleep apnea, signed informed consent, snoring with or without other symptoms, and age > 18 yr | Oxygen, CPAP | Diagnostic accuracy, diagnostic agreement, technical failures |
| Onder et al. (68) | Design: cross-sectional Location: Turkey No. of sites: 1 Device: WatchPAT 200 Channels: 4 | No. of patients: 59* Sex: 36 M, 20 F Mean age (pooled): 42 yr Comorbidities: NR Mean BMI (pooled): 30.5 Mean ESS: NR | NR | Peripheral vasculopathy, pharyngeal deformity, diabetes mellitus, nephropathy, α-adrenergic receptor blockers or thoracic sympathectomy | Technical failures, sleep indices |
| Orr et al. (69) (Abstract) | Design: cohort Location: USA No. of sites: 1 Device: LifeShirt Channels: NR | No. of patients: 48 Sex: NR Mean age: NR Comorbidities: NR Mean BMI: NR Mean ESS: NR | NR | NR | Diagnostic accuracy, diagnostic agreement |
| Su et al. (70) | Design: cohort Location: USA No. of sites: 1 Device: SNAP Channels: 4 | No. of patients: 60 Sex: 25 M, 35 F Mean age: 45.2 ± 12.3 yr Comorbidities: hypertension Mean BMI: 35.6 ± 10.1 Mean ESS: NR | Suspected OSAS, consecutive patient referrals | NR | Diagnostic accuracy, technical failure |
| Sullivan et al. (71) (Abstract) | Design: cohort Location: Canada No. of sites: 1 Device: Stardust Channels: 4 | No. of patients: 34 Sex: NR Mean age: NR Comorbidities: NR Mean BMI: NR Mean ESS: NR | NR | NR | Diagnostic accuracy, diagnostic agreement |
| Takama et al. (72) | Design: cohort Location: Japan No. of sites: 1 Device: Morpheus Channels: 4 | No. of patients: 99* Sex: 48 M, 35 F Mean age: 70 ± 10 yr Comorbidities: hypertension (75), dyslipidemia (66), diabetes mellitus (45), coronary artery disease (38), valvular disease (16), cardiomyopathy (16), other comorbid conditions (13) Mean BMI: NR Mean ESS: NR | Patients with coronary artery disease admitted to the hospital because of anterior chest pain or heart failure who had symptoms consistent with class II or III New York Heart Association classification | NR | Diagnostic accuracy |
| Tiihonen et al. (73) | Design: cohort Location: Finland No. of sites: 1 Device: APV2 remote analysis Channels: 4 | No. of patients: 10 Sex: 5 M, 5 F Mean age: 46.7 ± 12.6 yr Comorbidities: NR Mean BMI: 37.3 ± 10.5 Mean ESS: NR | Suspicion of OSA | NR | Diagnostic agreement |
| To et al. (74) | Design: cohort Location: Hong Kong No. of sites: 1 Device: ARES Unicorder Channels: 4 | No. of patients: 175 Sex: 132 M, 43 F Mean age: 47.8 ± 9.8 yr (M), 52.3 ± 12.2 yr (F) Comorbidities: hypertension (85), diabetes mellitus (27), hyperlipidemia (25), fatty liver (18), cerebrovascular accident (11) Mean BMI: 28.5 ± 4.9 (M), 29.2 ± 6.0 (F) Mean ESS: 9.8 ± 5.3 (M), 12.2 ± 5.0 (F) | Substantial sleepiness interfering with daily activities and 2 of the following symptoms: choking or gasping, recurrent awakenings, unrefreshed by sleep, daytime fatigue and impaired concentration | Pregnancy or patients who could not comply with the set-up of the device | Diagnostic agreement, technical failures |
| Yagi et al. (75) | Design: cohort Location: Japan No. of sites: 1 Device: Apnomonitor 5 Channels: 4 | No. of patients: 22 Sex: 17 M, 5 F Mean age: 52.9 ± 13.3 (31–74) yr Comorbidities: NR Mean BMI: 25.7 ± 4.4 (18.8–39.3) Mean ESS: NR | Suspected SAS | NR | Diagnostic accuracy, diagnostic agreement |
| Separate studies | |||||
| Alonso et al. (76) | Design: cohort Location: Spain No. of sites: 1 Device: Edentrace II Channels: 4 | No. of patients: 45 Sex: 39 M, 6 F Mean age: 52.3 ± 11 yr Comorbidities: hypertension (8), heart rhythm abnormalities (5), heart disease (3), cardiovascular accident (2), chronic obstructive pulmonary disorder (1), asthma (1) Mean BMI: 28.7 ± 4 Mean ESS: 8.9 ± 3 (0–19) | Suspected sleep apnea, residents of Burgos metropolitan area, and home suitable for study | Concomitant illness, symptoms of sleep disorders other than SAHS, occupation in which SAHS would increase occupational risk | Diagnostic accuracy, diagnostic agreement |
| Andreu et al. (77) | Design: RCT Location: Spain No. of sites: 1 Device: Stardust Channels: 4 | No. of patients: 66* Sex: 54 M, 11 F Mean age: 52 ± 10 yr Comorbidities: hypertension (32) Mean BMI: 34 ± 7 Mean ESS: ≥ 12 | ESS > 12 | Impaired lung function, patients previously using CPAP, psychiatric diseases, neoplasm, restless leg syndrome, other dyssomnias and parasomnias | Adverse events, technical failures, clinical management |
| Askenov et al. (78) (Abstract) | Design: cohort Location: USA No. of sites: 1 Device: NR Channels: NR | No. of patients: 452 (317 level 3, 135 level 1) Sex: NR Comorbidities: NR Level 3 Mean age: 59.1 ± 0.7 yr Mean BMI: 34.7 ± 0.5 Mean ESS: 13.9 ± 0.3 Level 1 Mean age: 59.2 ± 0.9 yr Mean BMI: 34.7 ± 0.6 Mean ESS: 14.5 ± 0.5 | Apnea–hypopnea index ≥ 5 | Patients using BPAP or PAP plus oxygen, or patients with no follow-up data | Clinical management outcomes, diagnostic agreement |
| Berry et al. (79) | Design: RCT Location: USA No. of sites: 1 Device: WatchPAT 100 Channels: 4 | No. of patients: 106 (53 PM, 53 PSG) Comorbidities: NR PM arm Sex: 46 M, 7 F Mean age: 51.9 ± 1.7 yr Mean BMI: 34.0 ± 0.08 Mean ESS: 16.6 ± 0.47 PSG arm Sex: 47 M, 6 F Mean age: 55.1 ± 1.5 yr Mean BMI: 34.4 ± 0.9 Mean ESS: 16.2 ± 0.54 | Excessive daytime sleepiness | Congestive heart failure, use of nocturnal oxygen, COPD, restless leg syndrome, use of narcotics, uncontrollable psychiatric disorders, night shift workers, previous treatment with CPAP, hypercapnia, neuromuscular diseases, cataplexy, use of α blockers | Clinical management outcomes |
| Bridevaux et al. (80) | Design: cross-sectional Location: Switzerland No. of sites: 1 Device: Embletta Channels: 4 | No. of patients: 11 Sex: NR Mean age: 54 ± 14 yr Comorbidities: NR Mean BMI: NR Mean ESS: NR | Suspected OSA | NR | Diagnostic agreement |
| Campbell et al. (81) | Design: cohort Location: New Zealand No. of sites: 1 Device: Siesta Sleep System Channels: NR | No. of patients: 31* Sex: 24 M, 6 F Mean age: 49.1 ± 13.8 (23–78) yr Comorbidities: NR Mean BMI: 31 ± 6.1 Mean ESS: 10.8 ± 4.9 (0–20) | Age > 18 yr, residence within the hospital’s catchment area | Psychiatric disease, cardiovascular disease, limited mobility | Diagnostic accuracy, technical failures |
| Chung et al. (82) | Design: cohort Location: Canada No. of sites: 2 Device: Embletta Channels: 3 | No. of patients: 24* Sex: 11 M, 10 F Mean age: 54 ± 11 yr Comorbidities: NR Mean BMI: 36 ± 9 Mean ESS: NR | Age > 18 yr | Unwilling or unable to give informed consent, other breathing disorder | Diagnostic agreement |
| Churchward et al. (83) (Abstract) | Design: cohort Location: Australia No. of sites: 1 Device: Somté Channels: NR | No. of patients: 20 Sex: 16 M, 4 F Mean age: 50 ± 13 yr Comorbidities: NR Mean BMI: 34 ± 8.3 Mean ESS: NR | Possible OSA | NR | Diagnostic accuracy |
| Cilli et al. (84) (Abstract) | Design: cohort Location: Turkey No. of sites: 1 Device: Embletta Channels: NR | No. of patients: 55 Sex: 49 M, 6 F Mean age: 46 yr Comorbidities: NR Mean BMI: NR Mean ESS: NR | NR | NR | Diagnostic accuracy |
| Danzi-Soares et al. (85) | Design: cohort Location: Brazil No. of sites: 1 Device: Stardust II Channels: 4 | No. of patients: 79* Sex: 53 M, 17 F Mean age: 58 ± 7 yr Comorbidity: coronary artery disease Mean BMI: 27.6 Mean ESS: 7 | Patients with coronary artery disease undergoing surgery | History of stroke and disability, clinical instability, use of supplemental oxygen | Diagnostic accuracy, diagnostic agreement |
| Finkel et al. (86) | Design: cohort Location: USA No. of sites: 1 Device: ARES Channels: 4 | No. of patients: 26 Sex: NR Mean age: NR Comorbidities: NR Mean BMI: NR Mean ESS: NR | Age > 18 yr, undergoing elective surgery | Previous diagnoses of OSA, use of home oxygen, allergy to synthetic material, inability to use sleep apnea detection device | Diagnostic accuracy |
| Fordyce et al. (87) (Abstract) | Design: cohort Location: Canada No. of sites: 1 Device: NR Channels: NR | No. of patients: 9 Sex: 6 M, 3 F Mean age: 40.3 yr Comorbidities: NR Mean BMI: 25.4 Mean ESS: NR | History of snoring | BMI ≥ 30, adjusted neck circumference ≥ 42 cm, ESS < 10 | Diagnostic accuracy |
| Furokawa et al. (88) | Design: cohort Location: Japan No. of sites: 1 Device: FM-500 Channels: 4 | No. of patients: 81 Sex: 51 M, 30 F Mean age: 64.9 ± 9.6 yr Comorbidity: hypertension Mean BMI: 25.9 ± 4.3 Mean ESS: 6.5 ± 4.1 (PSG) | Primary hypertension | NR | Diagnostic accuracy, diagnostic agreement, technical failures |
| Gjevre et al. (89) | Design: cohort Location: Canada No. of sites: 1 Device: Embletta Channels: 4 | No. of patients: 47 Sex: F Mean age: 52 ± 11 yr Comorbidities: NR Mean BMI: 34.9 ± 9.0 Mean ESS: 9.6 ± 4.4 (0–19) | Age > 21 yr | Neuromuscular disease, renal failure, suspicion of SDB other than OSA, cardiovascular diseases, cerebrovascular accidents | Diagnostic accuracy, diagnostic agreement. technical failures |
| Grover et al. (90) (Abstract) | Design: cohort Location: USA No. of sites: 1 Device: Alice Channels: 4 | No. of patients: 5 Sex: NR Mean age: NR (range 29–59 yr) Comorbidities: NR Mean BMI: NR Mean ESS: NR | Polysomnography naive | NR | Diagnostic agreement, technical failures |
| Hernandez et al. (91) | Design: cohort Location: Spain No. of sites: 2 Device: respiratory polygraph Channels: 4 | No. of patients: 88 Sex: 71 M, 17 F Mean age: 50.3 ± 11.6 yr Comorbidities: NR Mean BMI: 29.6 ± 4.2 Mean ESS: NR | SAHS | NR | Diagnostic accuracy, diagnostic agreement |
| Kuna et al. (92) | Design: RCT Location: USA No. of sites: 2 Device: Embletta Channels: NR | No. of patients: 296* Comorbidities: NR Mean ESS: NR Level 3 Sex: 108 M, 5 F Mean age: 55.1± 10.3 yr Mean BMI: 35.0 ± 7.5 Level 1 Sex: 104 M, 6 F Mean age: 51.8 ± 10.4 yr Mean BMI: 34.2 ± 5.2 | Suspected OSA | People with normal results on PSG or level 3 test with apnea–hypopnea index < 5, SDB other than OSA (such as central sleep apnea) | Clinical management outcomes |
| Lettieri et al. (93) | Design: cohort Location: USA No. of sites: 1 Device: Stardust Channels: 5 | No. of patients: 210 Comorbidities: NR Group 1 Sex: 45 M, 25 F Mean age: 50.4 ± 9.2 yr Mean BMI: 32.2 ± 4.8 Mean ESS: 14.8 ± 4.8 Group 2 Sex: 50 M, 20 F Mean age: 47.1 ± 8.0 yr Mean BMI: 30.0 ± 3.5 Mean ESS: 14.1 ± 4.2 Group 3 Sex: 48 M, 22 F Mean age: 45.5 ± 5.4 yr Mean BMI: 28.5 ± 3.0 Mean ESS: 13.9 ± 4.4 | Meet criteria for OSA with no comorbidity | Ineligibility for home sleep testing, cardiopulmonary disorder, hypertension, heart failure, coronary artery disease, poorly controlled asthma, moderate to severe COPD or supplementary oxygen requirement | Clinical management outcomes |
| Levendowski et al. (94) | Design: cohort Location: USA No. of sites: 3 Device: ARES Channels: 4 | No. of patients: 37 Sex: NR Mean age: NR Comorbidities: NR Mean BMI: NR Mean ESS: NR | Apnea–hypopnea index < 10 or > 40 based on in-home baseline study; BMI > 32; nonretropalatal airway obstruction; previous airway surgery other than nasal, adenoid or tonsil; and SDB other than OSA | None | Diagnostic agreement |
| Masa et al. (95) | Design: RCT Location: Spain No. of sites: 8 Device: BreastSC20 Channels: 4 | No. of patients: 377* Sex: 263 M, 85 F Mean age: 48.7 ± 11.8 yr Comorbidities: smoking (23.9%), heart disease (37%), cerebrovascular disease (1.9%), hypertension (30.7%), depression or anxiety (23.3%) Mean BMI: 31 ± 6.6 Mean ESS: 11.6 ± 5.5 | Age 18–70 yr, referral to sleep centre with snoring, witnessed apneas, and ESS > 10 or morning tiredness | Severe or unstable heart disease, suspected SDB other than SAHS, inability to set up portable monitor | Diagnostic accuracy, technical failures |
| Masdeu et al. (96) | Design: cohort Location: Spain No. of sites: 1 Device: ARES Channels: 4 | No. of patients: 85 (66 patients, 19 controls) Sex: 61 M, 24 F Mean age: 42.4 yr Comorbidities: NR Mean BMI: 29 Mean ESS: 7.8 | High likelihood of OSA | Congestive heart failure, central sleep apnea | Diagnostic accuracy Diagnostic agreement |
| Nakayama et al. (97) | Design: cross-sectional Location: Japan No. of sites: 1 Device: Morpheo Channels: 7 | No. of patients: 322 Sex: M Mean age: 43.8 ± 8.4 yr Comorbidity: hypertension Mean BMI: 23.7 ± 3.1 Mean ESS: 8.1 ± 4.3 | NR | NR | Diagnostic agreement, technical failures |
| Quintana-Gallego et al. (98) | Design: cohort Location: Spain No. of sites: 1 Device: Apneoscreen II Channels: 4 | No. of patients: 90* Sex: 65 M, 10 F Mean age: 56.1 ± 11.7 yr Comorbidities: CHF (stable heart failure due to systolic dysfunction [LVEF ≤ 45%], ischemic [42.3%], idiopathic [39.4%], other [18.3%]) Mean BMI: 28.6 ± 4.4 Mean ESS: NR | LVEF ≤ 45% and no change in drug doses for 4 wk before the study | Instability of heart failure, acute MI in the previous 3 mo, unstable angina, or congenital heart disease | Diagnostic accuracy, diagnostic agreement, technical failure |
| Rosen et al. (99) | Design: RCT, Location: USA No. of sites: 7 Device: Embletta Channels: 4 | No. of patients: 373 (197 completed) Comorbidities: NR Level 3 No. of patients: 187 No. completed: 105 Sex: 107 M, 80 F Mean age: 45.6 ± 11.6 yr Mean BMI: 37 ± 8.7 Mean ESS: 14 ± 3.9 Level 1 No. of patients: 186 No. completed: 92 Sex: 118M, 68 F Mean age: 46.3 ± 12.3 yr Mean BMI: 37.5 ± 8.7 Mean ESS: 14.1 ± 3.6 | High suspicion of OSA, ESS > 12 | Treatment with CPAP, substantial pulmonary disease, use of supplemental oxygen, awake hypercapnia or hypoventilation syndrome, respiratory or heart failure, neuromuscular disease, concerns about unsafe driving, chronic narcotic use, > 5 alcoholic drinks/d, uncontrolled psychiatric disturbance, or SDB other than OSA | Technical failures, clinical management outcomes |
| Shrivastava et al. (100) (Abstract) | Design: cohort Location: USA No. of sites: 1 Device: Edentrace Channels: NR | No. of patients: 99 Sex: NR Mean age: NR Comorbidities: NR Mean BMI: NR Mean ESS: NR | Community-based primary care clinic population | NR | Diagnostic accuracy |
| Skomro et al. (101) (Abstract) | Design: cohort Location: Canada No. of sites: 1 Device: Embletta Channels: 4 | No. of patients: 33 Sex: 27 M, 6 F Mean age: 48.3 ± 13.1 yr Comorbidities: NR Mean BMI: NR Mean ESS: 11.7 ± 4.2 | Referral for suspected OSA, age > 18 yr | Respiratory/heart failure, presence of other sleep disorders, safety-sensitive occupation, use of hypnotics, upper airway surgery, CPAP, pregnancy | Diagnostic accuracy, diagnostic agreement, technical failures |
| Skomro et al. (102) | Design: prospective RCT prospective Location: Canada No. of sites: 1 Device: Embletta Channels: 4 | No. of patients: 102 (51 in each arm)* Level 3 Sex: 30 M, 14 F Mean age: 47.8 ± 11.3 yr Comorbidities: NR Mean BMI: 31.4 ± 5.9 Mean ESS: 12.5 ± 3.6 Level 1 Sex: 30 M, 15 F Mean age: 49.8 ± 11.3 yr Comorbidities: NR Mean BMI: 34.6 ± 6.7 Mean ESS: 12.8 ± 4.8 | Suspicion of OSA, age > 18 yr, residence within a 1-h drive, ESS > 10 | Respiratory/heart failure, clinical features of another sleep disorder, CPAP or oxygen therapy, pregnancy and inability to provide informed consent | Clinical management outcomes |
| To et al. (103) | Design: prospective RCT Location: China No. of sites: 1 Device: ARES Channels: 4 | No. of patients: 371 Comorbidities: NR Algorithm I No. of patients: 187 Sex: 138 M, 49 F Mean age: 50.87 ± 0.80 yr Mean BMI: 29.05 ± 0.32 Mean ESS: 14.5 Algorithm II (at home) No. of patients: 184 Sex: 136 M, 48 F Mean age: 49.76 ± 0.78 yr Mean BMI: 28.90 ± 0.30 Mean ESS: 13.9 | Self-reported daytime sleepiness | Pregnancy, unwillingness to participate | Diagnostic accuracy, clinical management outcomes |
| Yin et al. (104) | Design: cohort Location: Japan No. of sites: 1 Device: Stardust II Channels: 4 | No. of patients: 90 (44 PSG) PSG Sex: 40 M, 4 F Mean age: 52.3 ± 13.5 yr Comorbidities: NR Mean BMI: 26.7 ± 5.3 Mean ESS: NR | Suspected OSA | NR | Diagnostic accuracy, diagnostic agreement |
Note: APAP = automatic positive airway pressure, BMI = body mass index, BPAP = bilevel positive airway pressure, COPD = chronic obstructive pulmonary disease, CPAP = continuous positive airway pressure, ESS = Epworth Sleepiness Scale, F = female, LVEF = left ventricular ejection fraction, M = male, MI = myocardial infarction, NR = not reported, OSA = obstructive sleep apnea, OSAS = obstructive sleep apnea syndrome, PAP = positive airway pressure, PAT = peripheral arterial tonometry, PM = portable monitoring, PSG = polysomnography, RCT = randomized controlled trial, SAH = sleep apnea–hypopnea, SAHS = sleep apnea–hypopnea syndrome, SAS = sleep apnea syndrome, SDB = sleep-disordered breathing.
↵* Not all patients completed the study. Results reported only for evaluable patients (i.e., those who completed the tests, had their records analyzed or who started CPAP treatment).