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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events" [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466309

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

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01466309     History of Changes
Other Study ID Numbers: Somnoguard in Thai OSA
Study First Received: November 1, 2011
Last Updated: November 6, 2011
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on August 01, 2014