ArticleNPJ digital medicine2024
FDA-cleared home sleep apnea testing devices.
Article in NPJ digital medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Diagnostic value of wearable and contactless technologies for detecting obstructive sleep apnea: a systematic review and meta-analysis.Sleep & breathing = Schlaf & Atmung · 2025Pooled it
- Prevalence of cognitive impairment among adults with obstructive sleep apnea: a systematic review and meta-analysis.Sleep & breathing = Schlaf & Atmung · 2025Pooled it
- A multifaceted approach for obstructive sleep apnea classification from ECG signal using deep learning.Npj biological timing and sleep · 2026Article
- Sleep patterns and glycemia in adults with cystic fibrosis-related diabetes: a remote pilot study.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2026Article
- Towards automatic home screening of obstructive sleep apnea using combined features from pulse wave amplitude, pulse-to-pulse interval and oxygen desaturation.Sleep & breathing = Schlaf & Atmung · 2026Article
- Toward Safer Diagnoses: A SEIPS-Based Narrative Review of Diagnostic Errors.Diagnostics (Basel, Switzerland) · 2026Review
- Sleep Apnoea and Memory (SAM): protocol for a prospective study of prevalence and symptoms of sleep apnoea in memory clinics.Frontiers in aging neuroscience · 2026Article
- SAS-CARE-1 study: stroke topography and polysomnography-based respiratory sleep characteristics.Sleep & breathing = Schlaf & Atmung · 2025Article
- Sleep-Disordered Breathing and Hypertension-A Systematic Review.Journal of clinical medicine · 2025Review
- Diagnostic Modalities in Sleep Disordered Breathing: Current and Emerging Technology and Its Potential to Transform Diagnostics.Respirology (Carlton, Vic.) · 2025Review
- Validation of a novel mask-based device for monitoring of comprehensive sleep parameters and sleep disordered breathing.Sleep & breathing = Schlaf & Atmung · 2025Observational
- Home Sleep Apnoea Testing: Advances, Challenges and Considerations in Heart Failure.Cardiac failure review · 2025Review
- Sensors, technologies, and classification algorithms for monitoring and diagnosis of sleep apnea.Digital healthReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
The demand for home sleep apnea testing (HSAT) devices is escalating, particularly in the context of the coronavirus 2019 (COVID-19) pandemic. The absence of standardized development and verification procedures poses a significant challenge. This study meticulously analyzed the approval process characteristics of HSAT devices by the U.S. Food and Drug Administration (FDA) from September 1, 2003, to September 1, 2023, with a primary focus on ensuring safety and clinical effectiveness. We examined 58 reports out of 1046 that underwent FDA clearance via the 510(k) and de novo pathways. A substantial surge in certifications after the 2022 pandemic was observed. Type-3 devices dominated, signifying a growing trend for both home and clinical use. Key measurement items included respiration and sleep analysis, with the apnea-hypopnea index (AHI) and sleep stage emerging as pivotal indicators. The majority of FDA-cleared HSAT devices adhered to electrical safety and biocompatibility standards. Critical considerations encompass performance and function testing, usability, and cybersecurity. This study emphasized the nearly indispensable role of clinical trials in ensuring the clinical effectiveness of HSAT devices. Future studies should propose guidances that specify stringent requirements, robust clinical trial designs, and comprehensive performance criteria to guarantee the minimum safety and clinical effectiveness of HSATs.
Identifiers
What OpenQuestion holds
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.