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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mitral

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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