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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMitral

About this trial

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

Qualifiers

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.

Disqualifiers

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 speak the official language of the research center.

Trial design

Treatments tested in this trial

  • Apneal device

Treatment groups

500 Participants
are divided into 1 treatment group

Sponsors and collaborators