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

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Device: Apneal device

• Registration Number: NCT06474143
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-07
• Study Start: 2024-02-28
• Study First Submitted QC: 2024-06-19
• Study First Posted: 2024-06-25
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epxerimental	Apneal device	Patients will wear the device during their polysomnographic recording

Primary Outcome Measures

Name	Time	Method
Performance of Apneal® in categorizing SAHS severity using AHI	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 Outcome Measures

Name	Time	Method
Correlation between AHI from Apneal and Berlin score	through study completion, an average of 1 year	The endpoint requires to assess the performances of Apneal® in screening OSAS, against Berlin questionnaire. The ground truth and predicted severities will be established and compared for each included individual. The first step is to output a score for each of these methods : * AHI for Apneal®; * Berlin score; The comparison of Apneal® with Berlin for sleep apnea screening will be conducted using ROC analysis.
Correlation between AHI from Apneal and AHI from PSG	through study completion, an average of 1 year	The endpoint requires to assess the performances of Apneal® against PSG first. The ground truth and predicted severities will be established and compared for each included individual.
Correlation between AHI from Apneal and Epworth sleepiness scale (ESS) score	through study completion, an average of 1 year	The endpoint requires to assess the performances of Apneal® in screening OSAS, against Berlin questionnaire. The ground truth and predicted severities will be established and compared for each included individual. The first step is to output a score for each of these methods : * AHI for Apneal®; * Epworth sleepiness scale (ESS) score; The comparison of Apneal® with ESS for sleep apnea screening will be conducted using ROC analysis.
Correlation between AHI from Apneal and AHI from nocturnal polygraphy	through study completion, an average of 1 year	The endpoint requires to assess the performances of Apneal® against polygraphy channels derived from PSG first. The ground truth and predicted severities will be established and compared for each included individual.
Correlation between AHI from apneal and ODI from nocturnal oximetry	through study completion, an average of 1 year	The endpoint requires to assess the performances of Apneal®, against nocturnal oximetry, . The ground truth and predicted severities will be established and compared for each included individual.; The comparison of Apneal® performance with nocturnal oximetry for sleep apnea screening will be conducted using ROC analysis.
Correlation between AHI from Apneal and STOPBANG score	through study completion, an average of 1 year	The endpoint requires to assess the performances of Apneal® in screening OSAS, against NoSAS . The ground truth and predicted severities will be established and compared for each included individual. The first step is to output a score for each of these methods : * AHI for Apneal®; * STOPBANG score; The comparison of Apneal® with STOPBANG for sleep apnea screening will be conducted using ROC analysis.
The segmentation of the night in snores and non-snores periods	through study completion, an average of 1 year	Segmentations of Apneal® and manual scoring of the recorded sound, by a sleep technologist in the centralized scoring center, will be compared.
Wake/night detection	through study completion, an average of 1 year	The segmentation of the night as wake and sleep predicted by Apneal® and manually scored on PSG will be compared.
Correlation between AHI from Apneal and NoSAS score	through study completion, an average of 1 year	The endpoint requires to assess the performances of Apneal® in screening OSAS, against NoSAS . The ground truth and predicted severities will be established and compared for each included individual. The first step is to output a score for each of these methods : * AHI for Apneal®; * NoSAS score; The comparison of Apneal® with NoSAS for sleep apnea screening will be conducted using ROC analysis.
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	The ground truth (from PSG) and predicted (from Apneal®) sleep stages classification will be established and compared for each included individual after : * the PSG and Apneal® data are recorded during the inclusion visit (sleep study); * the PSG sleep stages are estimated by the scorer in the centralized center, following AASM guidelines; * the ground truth sleep stages are output from these estimations or the adjudication committee if there is a disagreement between the two first scorers.; * Apneal® sleep stages are predicted automatically by the Apneal® algorithm. Sleep stages from Apneal® and PSG are compared using accuracy of the binary classifications.
Heart rate	through study completion, an average of 1 year	The heart rate predicted by Apneal®, compared with the heart rate derived from ECG on PSG.
Autonomic sleep fragmentation	through study completion, an average of 1 year	The autonomic sleep fragmentation index, which is the average amount of autonomic arousals per hour of sleep. It will be estimated by Apneal® and compared with the autonomic sleep fragmentation index derived from ECG on PSG.
Central apnea index	through study completion, an average of 1 year	amount of central apneas per hour of sleep. Apneal® will estimate this index, and it will be compared with the central apnea index measured on PSG.
Medicoeconomic study	through study completion, an average of 1 year	The estimated relative difference between the number of visits, with and without Apneal® in the clinical pathway
Position detection	through study completion, an average of 1 year	The segmentation of the participant's position in 6 categories: supine, left, right, prone, sitting and standing. Segmentation of Apneal® and PSG will be compared. position on PSG will be manually scored, position on Apneal is predicted automatically by the Apneal® algorithm.

Trial Locations

Locations (1)

Centre du sommeil, hôpital Bichat; 🇫🇷 Paris, France