Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA

Not Applicable

• Conditions: OSA; Complication

• Registration Number: NCT01466309
• Lead Sponsor: Mahidol University

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 Timeline

• Study Start: 2011-07
• Status Verified: 2011-11
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-06
• Study First Posted: 2011-11-06
• Last Update Submitted: 2011-11-06
• Last Update Posted: 2011-11-06
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age > 18 years with OSA
• AHI > 5
• Refused CPAP therapy

Exclusion Criteria

• Poor oral hygiene
• Untreated TMD
• Inadequate healthy teeth (< 6)
• Severe or unstable medical problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea index	1 year

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events"	1 year	Number of Participants with Adverse Events"

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand