Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis.
NCT Number: NCT06474143
Acronym: EASY
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Apnea Syndromes
Interventions: DEVICE: Apneal device
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-02-28
Completion Date: 2024-09-30
Locations: Centre du sommeil, hôpital Bichat, Paris, France

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)

Primary Outcome Measures: Performance of Apneal® in categorizing SAHS severity using AHI, 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), through study completion, an average of 1 year
Secondary Outcome Measures: Correlation between AHI from Apneal and AHI from PSG, 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., through study completion, an average of 1 year|Correlation between AHI from Apneal and AHI from nocturnal polygraphy, 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., through study completion, an average of 1 year|Correlation between AHI from apneal and ODI from nocturnal oximetry, 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., through study completion, an average of 1 year|Correlation between AHI from Apneal and NoSAS score, 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., through study completion, an average of 1 year|Correlation between AHI from Apneal and STOPBANG score, 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., through study completion, an average of 1 year|Correlation between AHI from Apneal and Berlin score, 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., through study completion, an average of 1 year|Correlation between AHI from Apneal and Epworth sleepiness scale (ESS) score, 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., 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)., 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., through study completion, an average of 1 year|The segmentation of the night in snores and non-snores periods, Segmentations of Apneal® and manual scoring of the recorded sound, by a sleep technologist in the centralized scoring center, will be compared., through study completion, an average of 1 year|Heart rate, The heart rate predicted by Apneal®, compared with the heart rate derived from ECG on PSG., through study completion, an average of 1 year|Autonomic sleep fragmentation, 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., through study completion, an average of 1 year|Central apnea index, 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., through study completion, an average of 1 year|Position detection, 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., through study completion, an average of 1 year|Wake/night detection, The segmentation of the night as wake and sleep predicted by Apneal® and manually scored on PSG will be compared., through study completion, an average of 1 year|Medicoeconomic study, The estimated relative difference between the costs of visits, with and without Apneal® in the clinical pathway, through study completion, an average of 1 year|Medicoeconomic study, The estimated relative difference between the number of visits, with and without Apneal® in the clinical pathway, through study completion, an average of 1 year