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

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country491 target enrollmentFebruary 28, 2024

ConditionsSleep Apnea Syndromes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Apnea Syndromes
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Enrollment: 491
Locations: 1
Primary Endpoint: Performance of Apneal® in categorizing SAHS severity using AHI
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

February 28, 2024

End Date

March 1, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

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;

Outcomes

Primary Outcomes

Performance of Apneal® in categorizing SAHS severity using AHI

Time Frame: through study completion, an average of 1 year

The primary endpoint of this study is the performance of Apneal® in categorizing SAHS severity in four classes compared to PSG: normal (AHI \< 5), mild (5 ≤ AHI \< 15), moderate (15 ≤ AHI \< 30), and severe (AHI ≥ 30)

Secondary Outcomes

Correlation between AHI from Apneal and Berlin score(through study completion, an average of 1 year)
Correlation between AHI from Apneal and AHI from PSG(through study completion, an average of 1 year)
Correlation between AHI from Apneal and Epworth sleepiness scale (ESS) score(through study completion, an average of 1 year)
Correlation between AHI from Apneal and AHI from nocturnal polygraphy(through study completion, an average of 1 year)
Correlation between AHI from apneal and ODI from nocturnal oximetry(through study completion, an average of 1 year)
Correlation between AHI from Apneal and STOPBANG score(through study completion, an average of 1 year)
The segmentation of the night in snores and non-snores periods(through study completion, an average of 1 year)
Wake/night detection(through study completion, an average of 1 year)
Correlation between AHI from Apneal and NoSAS score(through study completion, an average of 1 year)
The classification of sleep epochs into three categories : wake, REM sleep and NREM sleep (N1, N2 or N3).(through study completion, an average of 1 year)
Heart rate(through study completion, an average of 1 year)
Autonomic sleep fragmentation(through study completion, an average of 1 year)
Central apnea index(through study completion, an average of 1 year)
Medicoeconomic study(through study completion, an average of 1 year)
Position detection(through study completion, an average of 1 year)