Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Trial Parameters
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness of the Apneal® app in diagnosing sleep apnea syndrome (SAS) in adults who require polysomnography (PSG) as part of routine care. The main questions it aims to answer are: * Can Apneal® accurately classify the SAS severity into four categories (normal: AHI \< 5, mild: 5 ≤ AHI \< 15, moderate: 15 ≤ AHI \< 30, and severe: AHI ≥ 30) compared to PSG ? * How does Apneal® perform in estimating the Apnea-Hypopnea Index (AHI), detecting sleep stages, differentiating between central and obstructive apneas, and identifying patient movements? Participants will: * Wear the Apneal® app-equipped smartphone and undergo PSG during a full night of sleep at home. * Complete several questionnaires assessing sleep symptoms and experience with the Apneal® app.
Eligibility Criteria
Inclusion Criteria: * Individuals, male or female, aged 18 years or older (no upper age limit). * Individuals for whom polysomnography (PSG) is indicated as part of routine care, regardless of the specific indication. * Individuals with a reported total sleep time of at least 6 hours, in accordance with AASM recommendations for PSG analysis. * Individuals affiliated with social security or benefiting from a similar system, if applicable, in accordance with local regulations. * Voluntary individuals who have provided oral and written consent after being informed by the research investigator. Exclusion Criteria: * Individuals with an active implantable medical device (e.g., electronic cardiac implant, neurophysiological electrical stimulator). * Individuals with a chest deformity that prevents proper placement of the smartphone on the chest. * Individuals with uncontrolled psychiatric disorders that prevent them from giving full consent to the study. * Individuals unable to understand or