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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Mahidol University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01466309
First Posted: November 7, 2011
Last Update Posted: November 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mahidol University
  Purpose
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 Intervention
OSA Complication Device: Somnoguard oral appliances

Study Type: Interventional
Study Design: 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

Further study details as provided by Mahidol University:

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

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


Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
patients treated with Somnoguard
Device: Somnoguard oral appliances
wearing somnogaurd daily at bedtime

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.
  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01466309     History of Changes
Other Study ID Numbers: Somnoguard in Thai OSA
First Submitted: November 1, 2011
First Posted: November 7, 2011
Last Update Posted: November 7, 2011
Last Verified: November 2011

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