Validation of a novel mask-based device for monitoring of comprehensive sleep parameters and sleep disordered breathing.

PURPOSE: This study aimed to validate the new DormoTech Vlab device's performance, usability, and validity as a sleep test and physiological data recorder. The novel device has been designed for patient comfort, ease of use, and home-based assessment of sleep disordered breathing and other sleep-related measurements.

METHODS

Forty-seven adults (mean age = 52 years, 42% female, body mass index 29.4 kg/m2) underwent simultaneous testing with the DormoTech Vlab device and routine full polysomnography (PSG) using the Nox A1 system (K192469, Nox Medical). The sleep studies were manually and independently scored according to recommended guidelines. The primary outcome measure was the apnea-hypopnea index (AHI) and its corresponding conventional severity level (i.e., normal, mild, moderate, severe). Secondary endpoints included other standard PSG parameters.

RESULTS

The AHI was 21.7 ± 24.2 events/h (mean ± standard deviation) using the Vlab device versus 21.5 ± 23.9 events/h for gold standard PSG Nox A1 (p = 0.7). When AHI was grouped by severity, inter-test agreement was high (Cohen's kappa = 0.97). Results between the two systems were largely similar in the secondary endpoints, with high correlation between the two systems, and statistically significant (p < 0.05) differences only in REM latency measurements. The Vlab device provides similar sleep study data to conventional gold standard PSG and clinically near-identical test interpretation in almost all cases.

CONCLUSION

Based on these results, the Vlab device can be considered substantially equivalent to the reference Nox A1 system in terms of usability, efficacy, and validity.

CLINICAL TRIAL REGISTRATION: Trial name: Evaluation of the Usability and Performance Assessment of the DormoTech VLAB Device as a Home Sleep Test Identification number: NCT06224972. Date of Registration: 2023-12-06.