The Problem
The current gold standard for diagnosing sleep disorders is in-lab polysomnography (PSG), which is often inconvenient, costly, and may not reflect a patient’s natural sleep environment. While home-use devices exist, they often collect a limited set of data, leading to inconclusive results.
The Solution
The DormoVision X™ platform is an FDA-cleared, wearable, and wireless physiological data recorder designed for easy, self-administered home use. It collects full PSG data including respiratory signals (SpO2, airflow, snoring, thoracic and abdominal effort, heart rate), electrophysiological signals (EEG, EOG, EMG), and additional signals (limb EMG, body position, etc.), ensuring a level of data quality and validity equivalent to an in-lab PSG study.
The Validation Study Design & Methods
The study “Validation of a novel mask-based device for monitoring of comprehensive sleep parameters and sleep disordered breathing” was a comparative, observational clinical trial where 47 adults underwent simultaneous testing with the DormoVision X™ and the gold-standard Nox A1 PSG system.
47 Adults in a controlled sleep laboratory setting.
Simultaneous comparison with gold standard in-lab PSG
26 pediatric patients were recruited
Clinical Trial ID: NCT06224972
Study Population: 47 adults (mean age 52.2 years, 42% female) in a controlled laboratory setting.
Conclusion: High precision and reliability, supported by narrow 95% CI for mean bias.
DormoVision X™ Clinical Validation in Pediatrics
A prospective clinical study was conducted to evaluate the performance of DormoVision X™ in a pediatric population. The study compared the device’s readings to those of a gold-standard polysomnogram (PSG). The trial included 26 pediatric patients, with an average age of 11. It was a comparative, self-controlled, randomized, prospective study conducted over one night in a sleep lab.
The study found no significant differences in primary or secondary sleep endpoint measures between the DormoVision X™ and the predicate device. The findings demonstrated good agreement for most parameters, suggesting that for measures such as AHI, ODI, and Snore, the devices are interchangeable. The performance of the DormoVision X™, when compared to the gold-standard PSG, was determined to be substantially equivalent.
Endpoints Measured:
Primary Endpoint: Apnea-Hypopnea Index (AHI) score and classification, in accordance with AASM guidelines.
Secondary Endpoints: Oxygen Desaturation Index (ODI), total snore percentage, total sleep time, sleep efficiency, and sleep stages (Wake, N1, N2, N3, REM). The study also measured Sleep Latency, REM Latency, Wake After Sleep Onset, and body position.
Conclusion & Impact
DormoVision X™ provides equivalent sleep study data to conventional, gold-standard PSG. Its validity, efficacy, and ease of use demonstrate that it offers a reliable, comfortable, and clinically near-identical test interpretation for home-based sleep monitoring. Findings are based on the adult cohort (n=47). Equivalent results were also observed in the pediatric cohort (n=26, >6 years old), supporting device reliability across age groups. This advancement has the potential to:
Improve patient access to comprehensive sleep studies.
Reduce healthcare costs associated with in-lab PSG.
Increase patient comfort and compliance by moving diagnosis to the home.
Key Findings
Primary Endpoint (AHI): The DormoVision X™ Apnea-Hypopnea Index (AHI) values were not statistically different from the Nox A1 system (Vlab: 21.7 events/h vs. Nox: 21.5 events/h, p=0.7).
Exceptional AHI Severity Agreement: There was a very high inter-test agreement (Cohen’s kappa = 0.97) between the two devices when categorizing AHI severity levels (normal, mild, moderate, or severe). Only one out of 41 participants was categorized differently.
Secondary Parameters: DormoVision X™ also showed high agreement with the gold-standard system for most other key sleep parameters, including total sleep time (TST) and sleep stages.
Patient Usability: Usability questionnaires confirmed a positive user experience, with high scores for ease of use and comfort, and no reported adverse events.
DormoVision X™
The Next Generation of Sleep Diagnostics.
DormoVision X™ showed excellent agreement with the gold standard when classifying AHI severity levels, with a Cohen’s kappa of 0.97. Only 2.4% of participants were categorized differently.
References
McArdle N, Ward SV, Bucks RS et al (2020) The prevalence of common sleep disorders in young adults: a descriptive population-based study. Sleep 43(10):zsaa072.
Benjafield AV, Ayas NT, Eastwood PR et al (2019) Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med 7(8):687–698.
Senaratna CV, Perret JL, Lodge CJ et al (2017) Prevalence of obstructive sleep apnea in the general population: a systematic review. Sleep Med Rev 34:70–81.
Grandner MA, Jackson NJ, Pak VM, Gehrman PR (2012) Sleep disturbance is associated with cardiovascular and metabolic disorders. J Sleep Res 21(4):427–433.
