Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA

Complication Clinical Trial

— ThaiSomnoguard  

Official title:

The Efficacy of Adjustable Thermoplastic Oral Appliances in Thai Patient With OSA

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01466309
• Other study ID #: Somnoguard in Thai OSA
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 1, 2011
• Last updated: November 6, 2011
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2011
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication
• OSA

Intervention

Device:
• Somnoguard oral appliances
wearing somnogaurd daily at bedtime

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea index		1 year	Yes
Secondary	Number of Participants with Adverse Events"	Number of Participants with Adverse Events"	1 year	Yes