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:
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* 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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 29 September 2025