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

September 23, 2025 updated by: Mitral

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France, 13290
        • Recruiting
        • Centre de pneumologie et sommeil
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julien Soler, MD
        • Principal Investigator:
          • Laure-Aléa Essari, MD
      • Antony, France, 92160
      • Bordeaux, France, 33200
        • Recruiting
        • Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air
        • Contact:
        • Principal Investigator:
          • Kelly Guichard, MD
        • Principal Investigator:
          • Marc Sapène, MD
        • Principal Investigator:
          • Nathalie Raymond, MD
      • Montpellier, France, 34000
        • Not yet recruiting
        • SomnoLab - Millénaire
        • Contact:
        • Contact:
        • Principal Investigator:
          • François Bughin, MD
        • Principal Investigator:
          • Régis Lopez, MD
        • Principal Investigator:
          • Benoit Buttet, MD
      • Mulhouse, France, 68200
        • Recruiting
        • Cabinet de médecine du sommeil - Cabsom
        • Contact:
        • Principal Investigator:
          • Nicolas Saumier, MD
      • Paris, France, 75015
        • Recruiting
        • Somnology
        • Contact:
        • Principal Investigator:
          • Jérôme Pinot, MD
      • Paris, France, 75116
        • Not yet recruiting
        • Institut médical du sommeil
        • Contact:
        • Principal Investigator:
          • Sandrine Launois, MD
      • Reims, France, 51100
      • Roanne, France, 42300
        • Recruiting
        • Clinique du Renaison
        • Contact:
        • Principal Investigator:
          • Fabrice Charles, MD
      • Roanne, France, 42300
      • Soyaux, France, 16800
        • Not yet recruiting
        • Centre Clinical
        • Contact:
        • Principal Investigator:
          • Benoit Feger, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Patients will wear the device during their polysomnographic recording
Device: Apneal device
Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the performance of Apneal® in diagnosing sleep apnea-hypopnea syndrome (SAHS)
Time Frame: through study completion, an average of 1 year
Performance of Apneal® in classifying the severity of SAHS into four categories (normal: AHI < 5, mild: 5 ≤ AHI < 15, moderate: 15 ≤ AHI < 30, severe: AHI ≥ 30) compared to polysomnography (PSG).
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate the Apnea-Hypopnea Index (AHI) using Apneal®
Time Frame: through study completion, an average of 1 year
Concordance of AHI measured by Apneal® with AHI measured by PSG, and the mean absolute error between the two measurements.
through study completion, an average of 1 year
Compare Apneal® with screening questionnaires (NoSAS, Berlin, Epworth)
Time Frame: through study completion, an average of 1 year
Comparison of Apneal®'s performance with the NoSAS, Berlin, and Epworth questionnaires in classifying the severity of SAHS into the four categories (normal, mild, moderate, severe) relative to PSG.
through study completion, an average of 1 year
Differentiate central and obstructive apneas using Apneal®
Time Frame: through study completion, an average of 1 year
Estimation of the Central Apnea Index (CAI) by Apneal® compared to PSG, indicating the number of central apneas per hour of sleep.
through study completion, an average of 1 year
Detect patient movements with Apneal®
Time Frame: through study completion, an average of 1 year
Comparison of night segmentation by movements (presence/absence) between Apneal® and PSG, and evaluation of the number of movements detected by both.
through study completion, an average of 1 year
Evaluate patient acceptability of Apneal®
Time Frame: through study completion, an average of 1 year
Percentage of patients who agree to participate vs. those who refuse, including reasons for refusal (e.g., equipment-related issues, cognitive impairment).
through study completion, an average of 1 year
Assess the feasibility of SAHS screening using Apneal®
Time Frame: through study completion, an average of 1 year
Percentage of patients with usable data provided by Apneal® out of the total number of patients included; data considered unusable if Apneal® is lost during the night.
through study completion, an average of 1 year
Detect sleep stages using Apneal®
Time Frame: through study completion, an average of 1 year
The minimum concordance between Apneal® and PSG for both sleep stage durations (wake, REM, NREM: N1, N2, N3) and sleep stage latencies.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitral

Investigators

  • Principal Investigator: Ruben Wanono, MD, Chu de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A00042-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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