Status:
RECRUITING
Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Lead Sponsor:
Mitral
Conditions:
Sleep Apnea Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ma...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06578390
Start Date
March 26 2024
End Date
February 28 2026
Last Update
September 29 2025
Active Locations (11)
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1
Centre de pneumologie et sommeil
Aix-en-Provence, France, 13290
2
Centre du sommeil d'Antony
Antony, France, 92160
3
Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air
Bordeaux, France, 33200
4
SomnoLab - Millénaire
Montpellier, France, 34000