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Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: MitralUpdated: Sep 29, 2025Locations: 11
Eligibility criteria

Individuals, male or female, aged 18 years or older (no upper age limit). [+4]

Individuals with an active implantable medical device (e.g., electronic cardiac... [+5]