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

November 6, 2011 updated by: Mahidol University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Apnea-Hypopnea index
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events"
Time Frame: 1 year
Number of Participants with Adverse Events"
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: wish banhiran, MD, Yes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 6, 2011

First Posted (Estimate)

November 6, 2011

Study Record Updates

Last Update Posted (Estimate)

November 6, 2011

Last Update Submitted That Met QC Criteria

November 6, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Somnoguard in Thai OSA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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