Randomized Cross-over TRD and CPAP for OSA

June 1, 2016 updated by: Mahidol University

A Randomized Cross-over Study of Tongue Retaining Device and Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea

The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively. Wash-in period 1 week and Wash-out periods 1 week are required before start each treatment.

Study Type

Interventional

Enrollment (Anticipated)

36

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
        • Recruiting
        • Siriraj Hospital
        • Contact:
        • Principal Investigator:
          • wish - banhiran, MD

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. OSA patients aged over 18 years old at Siriraj hospital
  2. Apnea-hypopnea index (AHI) 5 - 30 events/ h or AHI > 30 events/h but lowest Oxygen saturation > 70%
  3. Positive consented form

Exclusion Criteria:

  1. Patients with severe periodontal diseases
  2. Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
  3. total sleep time less than 2 hour during previous sleep study
  4. Patients who could not tolerate the side effects of CPAP or TRD
  5. Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CPAP1 use and TRD 2use
Wash-in period 1 week and Continuous positive airway pressure (CPAP) is used for 3 weeks then wash-out 1 week and Tongue retaining device (TRD) is used for another 3 weeks
Device: Tongue retaining device
Tongue retaining device is used for 3 weeks
Device: CPAP
CPAP is used for 3 weeks
Other Names:
  • Continuous positive airway pressure
Experimental: TRD1 use and CPAP2 use
Wash-in period 1 week and Tongue retaining device (TRD) is used for 3 weeks then Wash-out period 1 week and Continuous positive airway pressure (CPAP) is used for another 3 weeks
Device: Tongue retaining device
Tongue retaining device is used for 3 weeks
Device: CPAP
CPAP is used for 3 weeks
Other Names:
  • Continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
apnea-hypopnea index (AHI)
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional outcomes of sleep questionnaire (FOSQ ) score
Time Frame: 3 weeks
3 weeks
Epworth sleepiness score (ESS) scores
Time Frame: 3 weeks
3 weeks
lowest oxygen saturation during sleep test at home
Time Frame: 3 weeks
3 weeks
side effects questionnaire
Time Frame: 3 weeks
3 weeks
satisfaction and preference of device questionnaire
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Anuch - Durongphan, MD, Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Estimate)

June 2, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R015932011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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