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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02144-41 | Registry Identifier | IDRCB |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epxerimental | Experimental | Patients will wear the device during their polysomnographic recording |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apneal device | Device | Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre du sommeil, hôpital Bichat | Paris | France |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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Each patient will wear the device and polysomnograph at the same time
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Polysomnography results not available to device
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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 :
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 :
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 :
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 :
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 :
| 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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |