Sleep Apnea SyndromesSESAMENCT06578390
Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
A study testing Apneal device in people with Sleep Apnea Syndromes, run by Mitral at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Apneal device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 11 sitesFrance
- Study dates
- 26 Mar 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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).
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Centre de pneumologie et sommeil
Aix-en-Provence, 13290
Julien Soler, MD, soler.julien@yahoo.fr
Laure-Aléa Essari, MD, laure.essari@orange.fr
- Recruiting
Centre du sommeil d'Antony
Antony, 92160
Franck Soyez, MD, fsoyez001@orange.fr
Fréderic Chalumeau, MD, chalumeauorl@gmail.com
- Recruiting
Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air
Bordeaux, 33200
Kelly Guichard, MD, kelly.guichard@gmail.com
Kelly Guichard, MD
- Not yet recruiting
SomnoLab - Millénaire
Montpellier, 34000
François Bughin, MD, fbughin@hotmail.com
Régis Lopez, MD, regislopez66@gmail.com
- Recruiting
Cabinet de médecine du sommeil - Cabsom
Mulhouse, 68200
Nicolas Saumier, MD, n.saumier@cabsom.fr
Nicolas Saumier, MD
- Recruiting
Somnology
Paris, 75015
Jérôme Pinot, MD, jerome.pinot@somnology.fr
Jérôme Pinot, MD
- Not yet recruiting
Institut médical du sommeil
Paris, 75116
Sandrine Launois, MD, slaunois@yahoo.com
Sandrine Launois, MD
- Recruiting
Cabinet privé du Dr. Wanono
Reims, 51100
Ruben Wanono, MD, docteur.ruben.wanono@gmail.com
Ruben Wanono, MD
- Recruiting
Clinique du Renaison
Roanne, 42300
Fabrice Charles, MD, docfabcharles@gmail.com
Fabrice Charles, MD
- Recruiting
Somnidoc
Roanne, 42300
Julien Favier, MD, dr.julien.favier@gmail.com
Maxime Stutz, MD, maximestutz@hotmail.fr
- Not yet recruiting
Centre Clinical
Soyaux, 16800
Benoit Feger, MD, drfeger.orl@gmail.com
Benoit Feger, MD
About this study
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?
Read more
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.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Apneal device
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apneal deviceDevice
Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients will wear the device during their polysomnographic recording Receives: Device: Apneal device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the performance of Apneal® in diagnosing sleep apnea-hypopnea syndrome (SAHS)
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).
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Estimate the Apnea-Hypopnea Index (AHI) using Apneal®
Concordance of AHI measured by Apneal® with AHI measured by PSG, and the mean absolute error between the two measurements.
Measured: through study completion, an average of 1 year
Compare Apneal® with screening questionnaires (NoSAS, Berlin, Epworth)
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.
Measured: through study completion, an average of 1 year
Detect sleep stages using Apneal®
The minimum concordance between Apneal® and PSG for both sleep stage durations (wake, REM, NREM: N1, N2, N3) and sleep stage latencies.
Measured: through study completion, an average of 1 year
Differentiate central and obstructive apneas using Apneal®
Estimation of the Central Apnea Index (CAI) by Apneal® compared to PSG, indicating the number of central apneas per hour of sleep.
Measured: through study completion, an average of 1 year
Detect patient movements with Apneal®
Comparison of night segmentation by movements (presence/absence) between Apneal® and PSG, and evaluation of the number of movements detected by both.
Measured: through study completion, an average of 1 year
Evaluate patient acceptability of Apneal®
Percentage of patients who agree to participate vs. those who refuse, including reasons for refusal (e.g., equipment-related issues, cognitive impairment).
Measured: through study completion, an average of 1 year
Assess the feasibility of SAHS screening using Apneal®
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start26 Mar 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient will wear the device and polysomnograph at the same time
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitral
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruben Wanono, MD, Principal investigator, CHU de Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578390
- Sponsor's protocol ID
- 2024-A00042-45
- Acronym
- SESAME
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
- ClinicalTrials.gov ID
- NCT06578390
- Acronym / sponsor ID
- SESAME / 2024-A00042-45
- Conditions
- Sleep Apnea Syndromes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- MitralIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient will wear the device and polysomnograph at the same time
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Apneal devicePatients will wear the device during their polysomnographic recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apneal devicePatients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography | Device | Experimental |
Primary outcome
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).
7 secondary outcomes
Estimate the Apnea-Hypopnea Index (AHI) using Apneal®
Time frame: 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
Detect sleep stages using Apneal®
Time frame: 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
Detect patient movements with Apneal®
Time frame: through study completion, an average of 1 year
Evaluate patient acceptability of Apneal®
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Comprehensive Opioid Management and Breathing During Sleep
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruben Wanono, MD principal investigator
CHU de Reims
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apneal device in people with Sleep Apnea Syndromes, run by Mitral at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Cathelain, PhD (+33672448711, guillaume.cathelain@apneal.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the performance of Apneal® in diagnosing sleep apnea-hypopnea syndrome (SAHS) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.