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

NCT ID: NCT06474143

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 491 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2025-03-01

Brief 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)

Conditions

Sleep Apnea Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Epxerimental

Patients will wear the device during their polysomnographic recording

Group Type: EXPERIMENTAL

Apneal device

Intervention Type: DEVICE

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

Interventions

Apneal device

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

Intervention Type: DEVICE

Eligibility Criteria

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 of indication.
• Individuals willing and able to comply with study requirements;
• Individuals with a declared total sleep time of at least 6 hours, as recommended by AASM for PSG analysis.
• Individuals affiliated to social security or beneficiary of such a scheme if applicable according to the local regulation ;
• Voluntary individuals who have provided oral and written consent after being informed by the research investigator.

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 the chest
• Individuals with uncontrolled psychiatric conditions impairing their ability to fully 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 or uncontrollable movements, other than periodic leg movement syndrome and restless leg syndrome.
• Refusal to participate in the study at any time during the clinical investigation;
• Individuals in period of exclusion from another protocol or currently participating in another interventional research study;
• Individuals not able to understand and speak the official language of the research center;
• Vulnerable individuals according to local legislation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre du sommeil, hôpital Bichat

Paris, , France

Countries

France

Other Identifiers

2023-A02144-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

C23-80

Identifier Type: -

Identifier Source: org_study_id