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Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Sponsor: Mitral
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
Conditions
Interventions
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