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Taking people in FranceNo phase

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

Key facts

Who runs it
Mitral
Where
Aix-en-Provence, Antony, Bordeaux, Montpellier, Mulhouse, Paris, Reims, Roanne, and Soyaux, FranceSee the 11 sites
Trial code
Status
Recruiting
People taking part
500 people, planned
Started
26 Mar 2024
Planned end
28 Feb 2026
Type of study
Interventional
Treatments tested
  • Apneal device
Record updated
29 September 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Individuals with an active implantable medical device (e.g., electronic cardiac implant, neurophysiological electrical stimulator)
  • Individuals with uncontrolled psychiatric disorders that prevent them from giving full consent to the study
  • Individuals with a chest deformity that prevents proper placement of the smartphone on the chest
  • 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 in France

  • Centre de pneumologie et sommeilAix-en-Provence, FranceContact: Julien Soler, MDTaking people
  • Centre du sommeil d'AntonyAntony, FranceContact: Franck Soyez, MDTaking people
  • Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-AirBordeaux, FranceContact: Kelly Guichard, MDTaking people
  • SomnoLab - MillénaireMontpellier, FranceContact: François Bughin, MDNot yet recruiting
  • Cabinet de médecine du sommeil - CabsomMulhouse, FranceContact: Nicolas Saumier, MDTaking people
  • Institut médical du sommeilParis, FranceContact: Sandrine Launois, MDNot yet recruiting
  • SomnologyParis, FranceContact: Jérôme Pinot, MDTaking people
  • Cabinet privé du Dr. WanonoReims, FranceContact: Ruben Wanono, MDTaking people
  • Clinique du RenaisonRoanne, FranceContact: Fabrice Charles, MDTaking people
  • SomnidocRoanne, FranceContact: Julien Favier, MDTaking people
  • Centre ClinicalSoyaux, FranceContact: Benoit Feger, MDNot yet recruiting

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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.

The group in the trial

  • ExperimentalTreatment being tested

    Patients will wear the device during their polysomnographic recording

    Treatment: Apneal device

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
29 September 2025