ThaiSomnoguard: Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA

• Sponsor: Mahidol University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01466309
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 17.1
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
OSA; Complication	Device: Somnoguard oral appliances	N/A

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
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Adjustable Thermoplastic Oral Appliances in Thai Patient With OSA
• Study Start Date: Jul 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment patients treated with Somnoguard	Device: Somnoguard oral appliances; wearing somnogaurd daily at bedtime

Outcome Measures

Primary Outcome Measures

1. Apnea-Hypopnea index [1 year]

Secondary Outcome Measures

1. Number of Participants with Adverse Events" [1 year]

   Number of Participants with Adverse Events"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Siriraj Hospital	Bangkoknoi	Bangkok	Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: wish banhiran, MD, Yes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT01466309
• Other Study ID Numbers: Somnoguard in Thai OSA
• First Posted: Nov 6, 2011
• Last Update Posted: Nov 6, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Mahidol University: AHI; ESS; VAS; FOSQ; SF-36

Study Results

No Results Posted as of Nov 6, 2011