Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA (ThaiSomnoguard)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01466309
First received: November 1, 2011
Last updated: November 6, 2011
Last verified: November 2011

November 1, 2011
November 6, 2011
July 2011
December 2012   (final data collection date for primary outcome measure)
Apnea-Hypopnea index [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01466309 on ClinicalTrials.gov Archive Site
Number of Participants with Adverse Events" [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Number of Participants with Adverse Events"
Same as current
Not Provided
Not Provided
 
Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA
The Efficacy of Adjustable Thermoplastic Oral Appliances in Thai Patient With OSA

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • OSA
  • Complication
Device: Somnoguard oral appliances
wearing somnogaurd daily at bedtime
Experimental: treatment
patients treated with Somnoguard
Intervention: Device: Somnoguard oral appliances
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01466309
Somnoguard in Thai OSA
No
Mahidol University
Mahidol University
Not Provided
Principal Investigator: wish banhiran, MD Yes
Mahidol University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP