Ignite Creation Date:
2024-05-06 @ 8:38 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02788487
Status:
UNKNOWN
Last Update Posted:
2016-06-02
First Post:
2016-05-27
Brief Title:
Randomized Cross-over TRD and CPAP for OSA
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
A Randomized Cross-over Study of Tongue Retaining Device and Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
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 objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients Primary outcomes are quality of life degree of sleepiness and severity of OSA determined by FOSQ ESS and AHI or RDI respectively
Detailed Description:
The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients Primary outcomes are quality of life degree of sleepiness and severity of OSA determined by FOSQ ESS and AHI or RDI respectively Wash-in period 1 week and Wash-out periods 1 week are required before start each treatment
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