A Multisite Randomized Trial of Portable Sleep Studies and Positive Airway Pressure Autotitration Versus Laboratory-Based Polysomnography for the Diagnosis and Treatment of Obstructive Sleep Apnea: The HomePAP Study
Open accessAbstract
STUDY OBJECTIVES: To test the utility of an integrated clinical pathway for obstructive sleep apnea (OSA) diagnosis and continuous positive airway pressure (CPAP) treatment using portable monitoring devices. DESIGN: Randomized, open-label, parallel group, unblinded, multicenter clinical trial comparing home-based, unattended portable monitoring for diagnosis and autotitrating CPAP (autoPAP) compared with in-laboratory polysomnography (PSG) and CPAP titration. SETTING: Seven American Academy of Sleep Medicine (AASM) accredited sleep centers. PARTICIPANTS: Consecutive new referrals, age 18 yr or older with high probability of moderate to severe OSA (apnea-hypopnea index [AHI] ≥ 15) identified by clinical algorithm and Epworth Sleepiness Scale (ESS) score ≥ 12. INTERVENTIONS: Home-based level 3 testing followed by 1 wk of autoPAP with a fixed pressure CPAP prescription based on the 90% pressure from autotitration of PAP therapy (autoPAP) device (HOME) compared with attended, in-laboratory studies (LAB). MEASUREMENTS: CPAP acceptance, time to treatment, adherence at 1 and 3 mo; changes in ESS, and functional outcomes. RESULTS: Of 373 participants, approximately one-half in each study arm remained eligible (AHI ≥ 15) to continue in the study. At 3 mo, PAP usage (nightly time at pressure) was 1 hr greater: 4.7 ± 2.1 hr (HOME) compared with 3.7 ± 2.4 hr (LAB). Adherence (percentage of night used ≥ 4 hr) was 12.6% higher: 62.8 ± 29.2% compared with 49.4 ± 36.1% in the HOME versus LAB. Acceptance of PAP therapy, titration pressures, effective titrations, time to treatment, and ESS score change did not differ between arms. CONCLUSIONS: 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. TRIAL REGISTRATION: http://www.ClinicalTrials.gov; Identifier: NCT: 00642486.
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Two RCTs demonstrated no clinically significant difference in general quality of life as assessed by the SF-36 mental component summary, physical component summary, and vitality scores when comparing home APAP versus an in-laboratory titration.
“Two RCTs 175,180 demonstrated no clinically significant difference in general QOL as assessed by the SF-36 mental component summary, physical component summary, and vitality scores when comparing home APAP versus an in-laboratory titration”
From Treatment of Adult Obstructive Sleep Apnea With Positive Airway Pressure: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment (2019) · cites this paper as [180]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredWhen determining adherence by number of nights with greater than 4 hours of use, meta-analysis of five RCTs found a clinically insignificant trend towards increased CPAP adherence in the HSAT arm versus the PSG arm.
“When determining adherence by number of nights with greater than 4 hours of use, meta-analysis of five RCTs found a clinically insignificant trend towards increased CPAP adherence in the HSAT arm versus the PSG arm”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [84]
The Adherence and Functional Outcomes section reports a higher percentage of nights with at least four hours of PAP use in the HOME arm: a nonsignificant difference at one month and a significant difference at three months. The paper reports its own randomized trial, not a meta-analysis of five RCTs, and does not characterize a pooled trend as clinically insignificant. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSix RCTs evaluated CPAP adherence (mean hours of use per night); meta-analysis found no significant difference between the two assessment pathways.
“Six RCTs evaluated CPAP adherence (mean hours of use per night); meta-analysis found no significant difference between the two assessment pathways”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [84]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredA meta-analysis of seven RCTs compared changes in patient-reported sleepiness, using the ESS, in patients diagnosed by HSAT or PSG, followed by PAP titration.
“A meta-analysis of seven RCTs compared changes in patient-reported sleepiness, using the ESS, in patients diagnosed by HSAT or PSG, followed by PAP titration”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [84]
The Analytic Strategy and Protocol sections describe a comparison of home-based and laboratory-based diagnosis and titration, with change in ESS-measured sleepiness as an outcome. Table 4 reports ESS changes in both arms. But this paper reports one randomized trial, not a meta-analysis of seven RCTs; page numbers are unavailable in our copy. (LLM, conf=0.91)
Experimental — accuracy not yet measuredSix studies evaluated cost, of which three reported a slightly reduced cost for a combined home-based diagnostic and treatment pathway, and three reported a lower cost for home APAP compared to in-laboratory titrations.
“Six studies evaluated cost, 35,175,177,[179][180][181] of which three 35,180,181 reported a slightly reduced cost for a combined home-based diagnostic and treatment pathway, and three 175,177,179 reported a lower cost for home APAP compared to in-laboratory titrations.”
One study demonstrated lower cost using a home-based pathway compared to the laboratory pathway where > 50% of the studies were split-night studies.
“Of note, one study 180 demonstrated lower cost using a home-based pathway compared to the laboratory pathway where > 50% of the studies were split-night studies.”
Meta-analysis of RCTs demonstrated no clinically significant difference in sleep-related quality of life when comparing PAP initiation using home APAP versus an in-laboratory titration.
“A meta-analysis combining 2 RCTs measuring sleep-related QOL with FOSQ, 175,176 2 RCTs measuring sleep-related QOL with SAQLI, 178,182 and one RCT 180 measuring both FOSQ and SAQLI demonstrated no clinically significant difference in sleep-related QOL when comparing PAP initiation using home APAP versus an in-laboratory titration”
Six RCTs, using various validated instruments (i.e., FOSQ, SAQLI, and SF-36), compared QOL in patients diagnosed by HSAT or PSG, followed by PAP titration.
“Six RCTs, using various validated instruments (i.e., FOSQ, SAQLI, and SF-36), compared QOL in patients diagnosed by HSAT or PSG, followed by PAP titration.”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [84]
Among the four RCTs most generalizable to clinical practice, three studies required use of PSG if HSAT was inconclusive and after 1 or 2 failed APAP trials.
“Among the four RCTs most generalizable to clinical practice, three studies83–85 required use of PSG if HSAT was inconclusive (did not provide adequate data or showed a low AHI after 1 or 2 unsuccessful attempts) and after 1 or 2 failed APAP trials (e.g., insufficient use, elevated residual AHI, persistent large leak).”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [84]
The study reported that in-trial costs were 25% less in the home-arm than the in-laboratory-arm.
“The study reported that in-trial costs were 25% less in the home-arm than the in-laboratory-arm.84”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [84]
These estimates were based on the Medicare Fee Schedule for the various study procedures, including office visits and diagnostic testing, and take into account the need to repeat studies.
“These estimates were based on the Medicare Fee Schedule for the various study procedures, including office visits and diagnostic testing, and take into account the need to repeat studies.84”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [84]
Among the four RCTs most generalizable to clinical practice, only one provided information on resource utilization.
“Among the four RCTs most generalizable to clinical practice,83–85,110 only one provided this information.84”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [84]
Rosen et al. 2012 reported that 30% (10/33) of subjects with technically inadequate HSATs and 16% (14/88) of subjects with low AHI on HSAT failed to proceed per protocol to PSG.
“Rosen et al. 201284 reported that 30% (10/33) of subjects with technically inadequate HSATs and 16% (14/88) of subjects with low AHI on HSAT failed to proceed per protocol to PSG.”
From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [84]
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- Authors
- Rosen, C. L., Auckley, D., Benca, R., Foldvary-Schaefer, N., Iber, C., Kapur, V., Rueschman, M., Zee, P., & Redline, S.
- Affiliations
- University Hospitals Cleveland Medical Center (US)
- MetroHealth Medical Center (US)
- University of Wisconsin–Madison (US)
- University of Minnesota (US)
- University of Washington (US)
- Brigham and Women's Hospital (US)
- Northwestern University (US)
- Corresponding author
- Rosen, Carol L.
- ORCID
- Venue
- Sleep
- Publisher
- Oxford University Press (OUP)
- Published
- 2012-06
- Volume
- 35
- Issue
- 6
- Pages
- 757-767
- ISSN
- 0161-8105 (ISSN-L)
- 1550-9109
- PMC
- PMC3353048
- OpenAlex
- W2170910182
- Semantic Scholar
- 3f105619f4cac45a06ff26315587b510625a7216
- Cited by
- 367
- References
- 35
- Citations by year
- 2026: 15 · 2025: 24 · 2024: 29 · 2023: 26 · 2022: 25 · 2021: 31 · 2020: 30 · 2019: 11 · 2018: 22 · 2017: 31 · 2016: 28 · 2015: 29 · 2014: 23 · 2013: 33 · 2012: 8
- FWCI
- 19.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- SLEEP (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Sleep Medicine Foundation (38-PM-07)
- Topics
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
- Keywords
- obstructive sleep apnea, home sleep testing, home sleep monitoring, auto-titrating CPAP, continuous positive airway pressure, polysomnography, CPAP adherence, CPAP acceptance, sleep apnea diagnosis, Epworth Sleepiness Scale, time to treatment, apnea-hypopnea index, sleep apnea treatment outcomes
- MeSH terms
- Female, Home Care Services, Humans, Male, Middle Aged, Patient Compliance, Treatment Outcome, Polysomnography, Sleep Apnea, Obstructive, Continuous Positive Airway Pressure
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