Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2023
A new wearable diagnostic home sleep testing platform: comparison with available systems and benefits of multinight assessments.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05421754 (Low Burden Wearable Sensor System for Diagnosing Obstructive Sleep Apnea Over Multiple Nights), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Low Burden Wearable Sensor System for Diagnosing Obstructive Sleep Apnea Over Multiple Nights: Diagnostic Agreement With Home Sleep Testing
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Home-testing devices for diagnosing obstructive sleep apnoea hypopnoea syndrome - a systematic review and economic evaluation.Health technology assessment (Winchester, England) · 2026Pooled it
- Modified Berlin Score for predicting sleep apnea in patients with acute ischemic stroke.BMC neurology · 2026Observational
- Diagnostic Modalities in Sleep Disordered Breathing: Current and Emerging Technology and Its Potential to Transform Diagnostics.Respirology (Carlton, Vic.) · 2025Review
- Association of adenoid hypertrophy and clinical parameters with preoperative polygraphy in pediatric patients undergoing adenoidectomy.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025Article
- Validation of Automated Respiratory Event Scoring in Type 3 Home Sleep Apnea Testing.Nature and science of sleep · 2025Article
- Distinct cognitive changes in male patients with obstructive sleep apnoea without co-morbidities.Frontiers in sleep · 2023Article
- New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2022.OTO openArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
Abstract
STUDY
objectivesWe assessed the real-world performance of the ANNE Sleep system against 2 Food and Drug Administration-cleared home sleep testing platforms and the intraindividual night-to-night variability of respiratory event index measured by ANNE Sleep.
methodsWe evaluated the home performance of the ANNE Sleep system compared with 2 Food and Drug Administration-cleared home sleep testing platforms (WatchPAT: n = 29 and Alice NightOne: n = 46) during a synchronous night with unsupervised patient application. Additionally, we evaluated night-to-night variability of respiratory event index and total sleep time using the ANNE Sleep system (n = 30).
resultsFor the diagnosis of moderate and severe obstructive sleep apnea, the ANNE Sleep system had a positive percent agreement of 58% (95% confidence interval, 28-85%) and a negative percent agreement of 100% (95% confidence interval, 80-100%) compared to WatchPAT. The positive and negative percent agreement for ANNE Sleep vs Alice NightOne was 85% (95% confidence interval, 66-96%) and 95% (95% confidence interval, 74-100%). There were no differences in mean total sleep time or respiratory event index across multiple nights of monitoring with ANNE. There were no differences consistent with a first-night effect but testing multiple nights reclassified obstructive sleep apnea severity in 5 (17%) individuals and detected 3 additional cases of moderate disease, with only a 12% (standard deviation, 28%) mean fluctuation in respiratory event index from the first night of testing compared to a mean of multiple nights. Overall, 80% of users found ANNE comfortable and easy to use.
conclusionsANNE Sleep exhibited stronger concordance with Alice NightOne compared to WatchPAT. While we illustrated low night-to-night variability for ANNE Sleep, the results suggest multiple nights increased detection of moderate or severe obstructive sleep apnea. CLINICAL
trial registrationRegistry: ClinicalTrials.gov; Name: ANNE Diagnostic Agreement With Home Sleep Testing; URL: https://clinicaltrials.gov/ct2/show/NCT05421754; Identifier: NCT05421754. CITATION: Walter J, Lee JY, Blake S, et al. A new wearable diagnostic home sleep testing platform: comparison with available systems and benefits of multinight assessments.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.