Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578390
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Efficacy Investigation of the Medical Device Apneal on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy Investigation of the Medical Device Apneal on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SESAME
Brief Summary:
The goal of this clinical trial is to evaluate the effectiveness of the Apneal app in diagnosing sleep apnea syndrome SAS in adults who require polysomnography PSG as part of routine care The main questions it aims to answer are
Can Apneal accurately classify the SAS severity into four categories normal AHI 5 mild 5 AHI 15 moderate 15 AHI 30 and severe AHI 30 compared to PSG
How does Apneal perform in estimating the Apnea-Hypopnea Index AHI detecting sleep stages differentiating between central and obstructive apneas and identifying patient movements
Participants will
Wear the Apneal app-equipped smartphone and undergo PSG during a full night of sleep at home
Complete several questionnaires assessing sleep symptoms and experience with the Apneal app
Can Apneal accurately classify the SAS severity into four categories normal AHI 5 mild 5 AHI 15 moderate 15 AHI 30 and severe AHI 30 compared to PSG
How does Apneal perform in estimating the Apnea-Hypopnea Index AHI detecting sleep stages differentiating between central and obstructive apneas and identifying patient movements
Participants will
Wear the Apneal app-equipped smartphone and undergo PSG during a full night of sleep at home
Complete several questionnaires assessing sleep symptoms and experience with the Apneal app
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None