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

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

Status

Enrolling

Conditions

Sleep Apnea Syndromes

Treatments

Device: Apneal device

Study type

Interventional

Funder types

Other

Identifiers

2023-A02144-41 (Registry Identifier)

C23-80

Details and patient eligibility

About

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)

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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