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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Apnea Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each patient will wear the device and polysomnograph at the same time

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental

Patients will wear the device during their polysomnographic recording

Group Type EXPERIMENTAL

Apneal device

Intervention Type DEVICE

Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography

Interventions

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Apneal device

Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes