Status:

UNKNOWN

Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA

Lead Sponsor:

Mahidol University

Conditions:

OSA

Complication

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

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 Criteria

Inclusion

  • Age \> 18 years with OSA
  • AHI \> 5
  • Refused CPAP therapy

Exclusion

  • Poor oral hygiene
  • Untreated TMD
  • Inadequate healthy teeth (\< 6)
  • Severe or unstable medical problems.

Key Trial Info

Start Date :

July 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2012

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT01466309

Start Date

July 1 2011

End Date

December 1 2012

Last Update

November 7 2011

Active Locations (1)

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1

Siriraj Hospital

Bangkoknoi, Bangkok, Thailand, 10700