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

Last updated: August 29, 2024
Sponsor: Mitral
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Apneal device

Clinical Study ID

NCT06578390
2024-A00042-45
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 withAASM recommendations for PSG analysis.

  • Individuals affiliated with social security or benefiting from a similar system, ifapplicable, in accordance with local regulations.

  • Voluntary individuals who have provided oral and written consent after beinginformed by the research investigator.

Exclusion

Exclusion Criteria:

  • Individuals with an active implantable medical device (e.g., electronic cardiacimplant, neurophysiological electrical stimulator).

  • Individuals with a chest deformity that prevents proper placement of the smartphoneon the chest.

  • Individuals with uncontrolled psychiatric disorders that prevent them from givingfull consent to the study.

  • Individuals unable to understand or speak the official language of the researchcenter.

  • Individuals currently excluded from another protocol or participating in anotherinterventional research study.

  • Vulnerable persons or adults under legal protection, including pregnant orbreastfeeding women, persons deprived of liberty by judicial or administrativedecision, individuals hospitalized without consent, or admitted for purposes otherthan research (Articles L1121-5 to L1121-8 of the French Public Health Code).

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Apneal device
Phase:
Study Start date:
March 26, 2024
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Centre de pneumologie et sommeil

    Aix-en-Provence, 13290
    France

    Active - Recruiting

  • Centre du sommeil d'Antony

    Antony, 92160
    France

    Active - Recruiting

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

    Bordeaux, 33200
    France

    Active - Recruiting

  • SomnoLab - Millénaire

    Montpellier, 34000
    France

    Site Not Available

  • Cabinet de médecine du sommeil - Cabsom

    Mulhouse, 68200
    France

    Active - Recruiting

  • Institut médical du sommeil

    Paris, 75116
    France

    Site Not Available

  • Somnology

    Paris, 75015
    France

    Active - Recruiting

  • Cabinet privé du Dr. Wanono

    Reims, 51100
    France

    Active - Recruiting

  • Clinique du Renaison

    Roanne, 42300
    France

    Active - Recruiting

  • Somnidoc

    Roanne, 42300
    France

    Active - Recruiting

  • Centre Clinical

    Soyaux, 16800
    France

    Site Not Available

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