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

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ClinicalTrials.gov Identifier: NCT01466309
Recruitment Status : Unknown
Verified November 2011 by Mahidol University.
Recruitment status was:  Enrolling by invitation
First Posted : November 7, 2011
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
OSA Complication Device: Somnoguard oral appliances Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : July 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

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



Primary Outcome Measures :
  1. Apnea-Hypopnea index [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events" [ Time Frame: 1 year ]
    Number of Participants with Adverse Events"



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466309


Locations
Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: wish banhiran, MD Yes

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01466309     History of Changes
Other Study ID Numbers: Somnoguard in Thai OSA
First Posted: November 7, 2011    Key Record Dates
Last Update Posted: November 7, 2011
Last Verified: November 2011

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