NCT01466309UnknownNot Applicable
The Efficacy of Adjustable Thermoplastic Oral Appliances in Thai Patient With OSA
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Mahidol University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Apnea-Hypopnea index
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years with OSA
- •Refused CPAP therapy
Exclusion Criteria
- •Poor oral hygiene
- •Untreated TMD
- •Inadequate healthy teeth (< 6)
- •Severe or unstable medical problems.
Arms & Interventions
treatment
Experimental
patients treated with Somnoguard
Intervention: Somnoguard oral appliances (Device)
Outcomes
Primary Outcomes
Apnea-Hypopnea index
Time Frame: 1 year
Secondary Outcomes
- Number of Participants with Adverse Events"(1 year)
Investigators
Study Sites (1)
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