Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis. (EASY)
Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis studY
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 Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France
- Centre du sommeil, hôpital Bichat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Epxerimental
Patients will wear the device during their polysomnographic recording
|
Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between AHI from Apneal and AHI from PSG
Time Frame: 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.
|
through study completion, an average of 1 year
|
|
Correlation between AHI from Apneal and AHI from nocturnal polygraphy
Time Frame: 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.
|
through study completion, an average of 1 year
|
|
Correlation between AHI from apneal and ODI from nocturnal oximetry
Time Frame: 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. |
through study completion, an average of 1 year
|
|
Correlation between AHI from Apneal and NoSAS score
Time Frame: 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 :
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
Time Frame: 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 :
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
Time Frame: 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 :
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
Time Frame: 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 :
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).
Time Frame: 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 :
|
through study completion, an average of 1 year
|
|
The segmentation of the night in snores and non-snores periods
Time Frame: 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.
|
through study completion, an average of 1 year
|
|
Heart rate
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: 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.
|
through study completion, an average of 1 year
|
|
Central apnea index
Time Frame: 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.
|
through study completion, an average of 1 year
|
|
Position detection
Time Frame: 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.
|
through study completion, an average of 1 year
|
|
Wake/night detection
Time Frame: 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.
|
through study completion, an average of 1 year
|
|
Medicoeconomic study
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: 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
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C23-80
- 2023-A02144-41 (Registry Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.