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ClinicalTrials.gov ID

NCT06578390

Lead Sponsor

MitralINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

500Estimated

Last Update Posted

Sep 29, 2025Actual

Start Date

Mar 26, 2024Actual

Primary Completion Date

Nov 30, 2025Estimated

Completion Date

Feb 28, 2026Estimated

Official Title

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

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 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.

• Sleep Apnea Syndromes

• Apneal device

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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).

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

MitralINDUSTRY

jerome.pinot@somnology.fr

dr.julien.favier@gmail.com