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RECRUITING
NCT06578390
NA

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

Sponsor: Mitral

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-03-26

Completion Date

2026-02-28

Last Updated

2025-09-29

Healthy Volunteers

Yes

Interventions

DEVICE

Apneal device

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

Locations (11)

Centre de pneumologie et sommeil

Aix-en-Provence, France

Centre du sommeil d'Antony

Antony, France

Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air

Bordeaux, France

SomnoLab - Millénaire

Montpellier, France

Cabinet de médecine du sommeil - Cabsom

Mulhouse, France

Somnology

Paris, France

Institut médical du sommeil

Paris, France

Cabinet privé du Dr. Wanono

Reims, France

Clinique du Renaison

Roanne, France

Somnidoc

Roanne, France

Centre Clinical

Soyaux, France