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NCT Number: NCT06578390

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

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de pneumologie et sommeil, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Apneal device

Device

Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Cathelain, PhD

CONTACT

[email protected]

+33672448711

Lola Martin

CONTACT

[email protected]

+33744475942

Sponsors and collaborators

Lead sponsor

Mitral

Industry

Registry information

Acronym: SESAME

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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