Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA (ThaiSomnoguard)
Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been reported its safety and efficacy in Caucasians at least in the short-term. However, there has been no reports in Thai patients. The objectives of this study is to investigate its efficacy and safety in Thai patients with OSA.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy of Adjustable Thermoplastic Oral Appliances in Thai Patient With OSA|
- Apnea-Hypopnea index [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Number of Participants with Adverse Events" [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Number of Participants with Adverse Events"
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
patients treated with Somnoguard
Device: Somnoguard oral appliances
wearing somnogaurd daily at bedtime
Fifty patients with any severity of OSA will be recruited according to the indications for oral appliance therapy in the practice parameters of the American Academy of Sleep Medicine (AASM)2006.