Evaluating a smartphone app for diagnosing sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Cabinet de médecine du sommeil - Cabsom
  Mulhouse, France Recruiting
• Somnology
  Paris, France Recruiting
• Cabinet privé du Dr. Wanono
  Reims, France Recruiting

Study contacts

• Principal investigator: Ruben Wanono, MD — CHU de Reims
• Study coordinator: Guillaume Cathelain, PhD
• Email: guillaume.cathelain@apneal.ai
• Phone: +33672448711

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.