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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
491
Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography
Centre du sommeil, hôpital Bichat
Paris, France
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)
Time frame: through study completion, an average of 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year