Study to Evaluate the Apneal Smartphone Device for Diagnosing Sleep Apnea in Adults Using Polysomnography

What this Trial Is About

Researchers are evaluating the effectiveness of the Apneal4 app on smartphones for diagnosing sleep apnea syndrome SAS in adults who require polysomnography PSG as part of their routine care. The study aims to determine if Apneal4 can accurately classify SAS severity into four categories, estimate the Apnea-Hypopnea Index AHI, detect sleep stages, differentiate between central and obstructive apneas, and identify patient movements compared to PSG. Participants will wear a smartphone equipped with the Apneal4 app on their chest during a full night of sleep at home while undergoing polysomnographic recording. They will also complete several questionnaires assessing sleep symptoms and their experience with the Apneal4 app. The study will monitor these measures over an average of one year to evaluate device performance and patient acceptability. During the study, participants will be assessed using both the Apneal4 device and standard PSG. Researchers will compare Apneal4 results with screening questionnaires like NoSAS, Berlin, and Epworth. Participants will complete questionnaires about their sleep symptoms and the devices ease of use. The primary outcome is the performance of Apneal4 in diagnosing sleep apnea-hypopnea syndrome. Safety and feasibility will be monitored throughout the study, which is expected to last about one year per participant.

Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis