Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139022
Status:
COMPLETED
Last Update Posted:
2007-10-10
First Post:
2005-08-26
Brief Title:
Home Diagnosis and Treatment of Obstructive Sleep Apnea
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
Can Obstructive Sleep Apnea be Diagnosed at Home A Randomised Trial of Home vsin-Lab Diagnosis and Treatment of OSA
Status:
COMPLETED
Status Verified Date:
2007-02
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:
Obstructive Sleep Apnea OSA is a common and underrecognised condition The diagnosis of OSA is typically made after an in-lab polysomnography PSG which requires an overnight stay in a sleep laboratory Many sleep laboratories have long waiting lists for PSG There are a number of portable devices which may be useful in home diagnosis of OSA however there is limited data on outcomes of OSA diagnosed and treated at home In this study we propose to compare diagnostic accuracy of a home monitoring device with a PSG and outcomes of OSA therapy when implemented at home vs in the sleep laboratory
Detailed Description:
We will randomise patients suspected to have OSA to either home evaluation and treatment using a portable monitor and auto-CPAP or in-lab evaluation with a PSG and manually-titrated CPAP We will obtain sleep sleepiness and quality of life questionnaires vigilance testing and blood pressure at baseline and after 1 2 4 and 12 weeks of therapy We will also assess and compare compliance with CPAP therapy in each arm of the study
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