Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis.

Last updated: July 9, 2025
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Overall Status: Completed

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Apneal device

Clinical Study ID

NCT06474143
C23-80
2023-A02144-41
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to test the ability of the Apneal application in diagnosing sleep apnea in adult patients.

Participants will be asked to wear the Apneal device during their fulll-night sleep test (polysomnography, the gold standard for sleep apnea)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals, men or women, aged over 18 and with no upper age limit;

  • Individuals for whom PSG is indicated as part of routine care, regardless ofindication.

  • Individuals willing and able to comply with study requirements;

  • Individuals with a declared total sleep time of at least 6 hours, as recommended byAASM for PSG analysis.

  • Individuals affiliated to social security or beneficiary of such a scheme ifapplicable according to the local regulation ;

  • Voluntary individuals who have provided oral and written consent after beinginformed by the research investigator.

Exclusion

Exclusion Criteria:

  • Individuals with active implantable medical devices (e.g. electronic heart implant,electrical neurophysiological stimulator...);

  • Individuals with mechanical heart valves;

  • Individuals with chest deformity preventing the phone to be correctly placed on thechest

  • Individuals with uncontrolled psychiatric conditions impairing their ability tofully consent to the study

  • Individuals suffering from epilepsy or an associated disorder;

  • Individuals suffering from a moderate to severe valvular disease;

  • Individuals under CPAP treatment during the participation.

  • Individuals suffering from a nervous system disorder that causes unintended oruncontrollable movements, other than periodic leg movement syndrome and restless legsyndrome.

  • Refusal to participate in the study at any time during the clinical investigation;

  • Individuals in period of exclusion from another protocol or currently participatingin another interventional research study;

  • Individuals not able to understand and speak the official language of the researchcenter;

  • Vulnerable individuals according to local legislation

Study Design

Total Participants: 491
Treatment Group(s): 1
Primary Treatment: Apneal device
Phase:
Study Start date:
February 28, 2024
Estimated Completion Date:
March 01, 2025

Connect with a study center

  • Centre du sommeil, hôpital Bichat

    Paris,
    France

    Site Not Available

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