Evaluating a smartphone app for diagnosing sleep apnea
Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
This study is testing a smartphone app to see if it can accurately diagnose sleep apnea in adults compared to traditional sleep tests done at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mitral Industry-sponsored |
| Locations | 11 sites (Aix-en-Provence and 10 other locations) |
| Trial ID | NCT06578390 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of the Apneal® app in diagnosing sleep apnea syndrome (SAS) in adults who require polysomnography (PSG). Participants will use the app-equipped smartphone while undergoing PSG at home, allowing for a comparison of the app's ability to classify SAS severity and estimate the Apnea-Hypopnea Index (AHI) against traditional PSG methods. The study will also evaluate the app's performance in detecting sleep stages and differentiating between types of apneas. Participants will complete questionnaires regarding their sleep symptoms and experiences with the app.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require PSG for sleep apnea evaluation.
Not a fit: Patients with active implantable medical devices or significant chest deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this app could provide a more accessible and efficient method for diagnosing sleep apnea, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using mobile technology for sleep apnea diagnosis, but the specific application of the Apneal® app is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Aix-en-Provence and 10 other locations
- Centre de pneumologie et sommeil — Aix-en-Provence, France (Recruiting)
- Centre du sommeil d'Antony — Antony, France (Recruiting)
- Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air — Bordeaux, France (Recruiting)
- SomnoLab - Millénaire — Montpellier, France (Not_yet_recruiting)
- Cabinet de médecine du sommeil - Cabsom — Mulhouse, France (Recruiting)
- Somnology — Paris, France (Recruiting)
- Institut médical du sommeil — Paris, France (Not_yet_recruiting)
- Cabinet privé du Dr. Wanono — Reims, France (Recruiting)
- Clinique du Renaison — Roanne, France (Recruiting)
- Somnidoc — Roanne, France (Recruiting)
- Centre Clinical — Soyaux, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Ruben Wanono, MD — CHU de Reims
- Study coordinator: Guillaume Cathelain, PhD
- Email: guillaume.cathelain@apneal.ai
- Phone: +33672448711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.