TABLE VI.F. 2.

Home sleep study testing compared to PSG

Study	Year	LOE	Study design	Study groups	Clinical endpoint	Conclusion
Kushida et al.578	2005	1a	Guideline	3464 studies	Standards of practice: AASM indications for PSG for sleep disorders.	For patients with high-pretest-probability, type III sleep study may be an acceptable alternative to full-night PSG. In the unattended setting, or in patients without high pretest probability stratification, the data does not support the use of these devices.
Collop et al.579	2007	1a	Systematic review	70 studies	Clinical Guidelines for the use of unattended portable monitors in diagnosing OSA.	Portable monitoring for the diagnosis of OSA should be performed only in conjunction with a comprehensive sleep evaluation. In the absence of a comprehensive sleep evaluation, there is no indication for portable monitoring.
Collop et al.573	2011	1a	Systematic review	27 RCTs	OOC testing with devices that measure Sleep, Cardiovascular, Oximetry, Position, Effort, Respiratory (SCOPER) parameters.	The literature is currently inadequate to state that a thermistor alone without any effort sensor is adequate to diagnose OSA.
Masa et al.580	2011	1b	Multicenter, randomized, blinded crossover study	366 patients suspected of OSA	Diagnostic and cost effectiveness of home testing compared with in-hospital PSG.	Home respiratory polygraphy is a cost-effective alternative to polysomnography for sleep apnea/hypopnea diagnosis. Telematic procedures may help patients with limited mobility and those who live a long way from the sleep center.
Masa et al.589	2013	1b	Randomized control blinded trial	348 patients with suspected OSA	Diagnostic cost-effectiveness of a sequential HRP scoring protocol compared with manual HRP scoring, and with in-hospital PSG.	Manual HRP scoring had better agreement than automatic HRP scoring; The sequential HRP protocol is a cost-effective alternative to PSG; and the cost savings of the sequential HRP protocol is low in comparison to the manual HRP protocol.
Kim et al.138	2015	1a	Economic analysis of RCT-home PAP	373 at risk for moderate to severe OSA	Cost-minimization analysis of home vs. lab sleep study.	Per subject costs for the in-lab testing were $1840 compared to $1575 for home testing for the payer. Costs for the laboratory arm were $1697 compared to $1736 in the home arm for the provider.
Jonas et al.458	2017	1a	Randomeffects meta-analyses	110 studies	Review primary care–relevant evidence on screening adults for OSA, test accuracy, and treatment of OSA.	There is uncertainty about the clinical utility of all potential screening tools. Although screening with multivariable apnea prediction, followed by home PM testing may have promise for distinguishing persons in the general population who are more or less likely to have OSA, current evidence is limited.
Abrahamyan et al.585	2018	1a	Systematic review and meta-analysis	24 full-text articles for final review	Systematically review the evidence on diagnostic ability of type IV PMs compared to PSG for OSA diagnosis.	Use of Level 4 PMs in clinical practice can potentially widen access to diagnosis and treatment of OSA, but evidence is not strong.
Corral et al.590	2017	1b	Multicentric noninferiority RCT with two open parallel arms and a cost-effectiveness analysis	430 screened patients with sleep apnea suspicion	Long-term effectiveness of home versus lab PSG in patients with intermediate-to-high sleep apnea suspicion.	The home testing protocol was noninferior to the PSG protocol based on the Epworth scale. Home testing was the Most cost-effective protocol, with a lower per-patient cost of 416.7€.
Douglas et al.591	2017	1a	Guideline/position paper utilizing well designed RCTs		Consensus statement on the indications and performance of sleep studies in adults.	There is increasing evidence supporting the use of some home-based type III and IV type sleep studies to “rule-in” moderate to severe obstructive sleep apnea in high prevalence obstructive sleep apnea, and should be used under the supervision of an accredited sleep physician.
Kapur et al.572	2017	1a	Systematic review and meta-analysis	98 studies included in evidence-based recommendations and 86 included in meta-analysis Clinical practice guideline (AASM).	Guidelines on appropriate and effective diagnosis of OSA.	Polysomnography, or home sleep apnea testing with a technically adequate device, is used for the diagnosis of OSA in uncomplicated adult patients presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA. If a single home sleep apnea test is negative, PSG be performed for the diagnosis of OSA.
El Shayeb et al.583	2014	1a	Systematic review and meta-analysis	From 59 studies, 19 studies were included in the meta-analysis	Assess the diagnostic accuracy of Level 3 testing compared with Level 1 testing and to identify the appropriate patient population for each test.	Level 3 sleep studies are safe and convenient for diagnosing OSA in patients with a high pretest probability of moderate to severe forms of the condition without substantial comorbidities.
Rosen et al.592	2012	1b	Randomized, open-label, parallel group, unblinded, multicenter clinical trial	7 AASM accredited centers recruited adults with high probability of OSA and ESS > 12 Home PAP study	To test the utility of an integrated clinical pathway for OSA diagnosis and CPAP treatment using portable monitoring devices.	A home-based strategy for diagnosis and treatment compared with in-laboratory PSG was not inferior in terms of acceptance, adherence, time to treatment, and functional improvements.
Gabriela et al.593.	2019	2b	Randomized, prospective, cross-over and single blind clinical trial	251 patients	Automatic validation of a new HRP system.	The automatic analysis of the HRP BTI-APNiA software presents a high validity in comparison to the AHI results measured by PSG. HRP BTI-APNiA is a valid alternative to PSG.
Flemons et al.594	2003	1a	Systematic review	51 studies	To assess the utility of portable monitors in diagnosing sleep apnea in adults.	High-quality studies of type III monitors in the sleep laboratory attended setting had low false-positive rates; most studies found a threshold that distinguished patients with sleep apnea from those without.
Chesson et al.595	1997	2a	Systematic review	MEDLINE search; January 1966–April 1996	Indications for PSG.	22% failure rate of home-based study to diagnose OSA.
Garcia-Diaz et al.596	2007	1b	Prospective randomized study with blinded analysis	62 patients with suspected OSA included	Utility and reliability of a respiratory polygraphy (RP) device with actigraphy in the diagnosis of sleep apnea-hypopnea syndrome.	HPR is an effective and reliable technique for the diagnosis of SAHS, although it is less sensitive than LRP. Wrist actigraphy improves the results of HRP only slightly.
Ayappa et al.597	2008	2b	Prospective study with blinded analysis	102 subjects recruited. 96 returned to lab	Validity of the Apnea Risk Evaluation System (ARES) Unicorder, for the evaluation of sleep disordered breathing.	ARES Unicorder provides acceptably accurate estimates of SDB indices compared to conventional laboratory NPSG for both the simultaneous and in-home ARES data.
Garg et al.581	2014	1b	RCT crossover	75 urban African Americans with high pre-test probability of OSA, identified with the Berlin questionnaire	Feasibility of home PM in an urban population at risk for OSA compared to in-laboratory polysomnography (PSG) and patient preference with respect to home PM versus PSG.	Home PM for diagnosis of OSA in a high-risk urban population is feasible, accurate, and preferred by patients. As home PM may improve access to care, the cost-effectiveness of this diagnostic strategy for OSA should be examined in underserved urban and rural populations.
Skomro et al.598	2010	1b	Randomized trial	102 subjects	Compared subjective sleepiness, sleep quality, quality of life, BP, and CPAP adherence after 4 weeks of CPAP therapy in subjects diagnosed via lab versus home testing.	Compared with the home-based protocol, diagnosis and treatment of OSA in the sleep laboratory does not lead to superior 4-week outcomes in sleepiness scores, sleep quality, quality of life, BP, and CPAP adherence.
Abraham et al.584	2006	2b	Prospective multi-center study	50 patients with NYHAIII CHF (SEARCH study)	Validity and clinical utility of home testing for SDB and arrhythmias in HF.	With CPS compared in in-lab PSG, the diagnostic accuracy was between 83% and 87% for OSA based on AHI of 5, 10, and 15.
Bravata et al.599	2017	1a	Randomized controlled intervention trial	225 randomized patients	Evaluate whether the intervention strategy improved sleep apnea detection and treatment, and hypertension control among patients with chronic cerebrovascular disease and hypertension.	The use of portable polysomnography, and auto-titrating CPAP in the patients’ homes, improved both the diagnosis and the treatment for sleep apnea compared with usual care but did not lower blood pressure.
Kotzian et al.586	2018	1b	Single-blind, single center, randomized controlled trial	55 patients (HOPES study)	Determine whether PAP adherence in patients who had a stroke with OSA can be improved by a PAP training strategy during in hospital rehabilitation combined with a telemedicine monitoring system after discharge.	Pre-results to our clinical experience, a severe SA in the screening PG remains a severe SA also in PSG. The diagnosis will not Change. We think that patients who had severely affected stroke need a quick access to therapy.
Fitzpatrick et al.600	2020	1b	Randomized, parallel, multicenter, single-blind, pragmatic controlled trial	233 patients (SIESTA Trial)	To evaluate the accuracy of the clinical diagnosis of OSA informed by the home sleep study with a type IV portable monitor versus type I polysomnography	Home testing with portable devices plays a valuable role for diagnosing of OSA in a variety of settings.
Hui et al.601	2017	1b	Prospective, randomized controlled CPAP parallel study	316 patients	Comparisons of home-based versus hospital-based approach in managing patients with suspected obstructive sleep apnea.	Home-based approach is non-inferior to hospital-based approach in managing patients with suspected OSAS, with shorter waiting time, and substantial cost savings.
Mulgrew et al.602	2007	1b	Randomized, controlled, open-label trial	68 patients	To test the utility of a diagnostic algorithm in conjunction with ambulatory CPAP titration in initial management of obstructive sleep apnea.	In patients with a high probability of obstructive sleep apnea, PSG confers no advantage over the ambulatory approach in terms of diagnosis and CPAP titration. The ambulatory approach may improve adherence to treatment. When access to PSG is inadequate, the ambulatory approach can expedite management of patients in need of treatment.
Guerrero et al.603	2014	1b	Randomized, blinded, crossover study	56 patients	Evaluate three night portable monitoring for OSA diagnosis.	Three consecutive nights of portable monitoring at home evaluated by a qualified sleep specialist is useful for the management of patients without high pretest probability of obstructive sleep apnea or with comorbidities.
Ferber et al.604	1994	2a	Systematic review	Literature review; MEDLINE (1966–1994)	Usefulness of portable Recording in the assessment of OSA.	No clear guidance for who is appropriate for home testing.
Morales et al.605	2012	2a	Prospective cohort study	452 participants	Assess utility of home testing for the elderly with the complaint of daytime sleepiness.	Unattended, self-assembled, in-home sleep studies recording airflow and respiratory effort are most useful along with a comprehensive sleep history, is accurate in identifying severe OSAS in older adults.
Pietzsch et al.606	2011	1b	Decision- analytic Markov model using Tree-Age Pro 2009 Suite	Comparison of clinical health guidelines and health- economic studies	Benefits and cost-effectiveness of diagnostic tests.	For payers, a home-based diagnostic pathway for obstructive sleep apnea with robust patient support incurs fewer costs than a laboratory-based pathway. For providers, costs are comparable if not higher, resulting in a negative operating margin.