Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354614
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2006-07-18
Brief Title:
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea OSA
Sponsor:
ResMed
Organization:
ResMed
Study Overview
Official Title:
Validation of the ApneaLink Sleep Screener in a Suspected Sleep Disordered Breathing Population
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary endpoints for this study are that the AL validation will 1 achieve a sensitivity of greater than 80 for AHI values greater than or equal to 15 and 2 demonstrate a correlation coefficient of r075 indicating strong correlation between the AHI of diagnostic PSG and AL
Detailed Description:
All subjects with suspected Sleep Disordered Breathing SDB scheduled for diagnostic polysomnography PSG will be invited to participate in the study to be tested to determine if they have Sleep Disordered Breathing SDB using the ApneaLink AL Sleep Screener Subjects initially will be tested for SDB in the home environment Following an AL home test subjects will undergo a simultaneous attended diagnostic polysomnography PSG sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None