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

Mitral

Status

Enrolling

Conditions

Sleep Apnea Syndromes

Treatments

Device: Apneal device

Study type

Interventional

Funder types

Industry

Identifiers

NCT06578390

2024-A00042-45

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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 speak the official language of the research center.
Individuals currently excluded from another protocol or participating in another interventional research study.
Vulnerable persons or adults under legal protection, including pregnant or breastfeeding women, persons deprived of liberty by judicial or administrative decision, individuals hospitalized without consent, or admitted for purposes other than research (Articles L1121-5 to L1121-8 of the French Public Health Code).