Actively Recruiting
Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Led by Mitral · Updated on 2025-09-29
500
Participants Needed
11
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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).
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Centre de pneumologie et sommeil
Aix-en-Provence, France, 13290
Actively Recruiting
2
Centre du sommeil d'Antony
Antony, France, 92160
Actively Recruiting
3
Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air
Bordeaux, France, 33200
Actively Recruiting
4
SomnoLab - Millénaire
Montpellier, France, 34000
Not Yet Recruiting
5
Cabinet de médecine du sommeil - Cabsom
Mulhouse, France, 68200
Actively Recruiting
6
Somnology
Paris, France, 75015
Actively Recruiting
7
Institut médical du sommeil
Paris, France, 75116
Not Yet Recruiting
8
Cabinet privé du Dr. Wanono
Reims, France, 51100
Actively Recruiting
9
Clinique du Renaison
Roanne, France, 42300
Actively Recruiting
10
Somnidoc
Roanne, France, 42300
Actively Recruiting
11
Centre Clinical
Soyaux, France, 16800
Not Yet Recruiting
Research Team
G
Guillaume Cathelain, PhD
CONTACT
L
Lola Martin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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