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Randomized Cross-over TRD and CPAP for OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Tongue retaining device
CPAP
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CPAP1 use and TRD 2use

TRD1 use and CPAP2 use

Arm Description

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

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

Outcomes

Primary Outcome Measures

apnea-hypopnea index (AHI)

Secondary Outcome Measures

Functional outcomes of sleep questionnaire (FOSQ ) score
Epworth sleepiness score (ESS) scores
lowest oxygen saturation during sleep test at home
side effects questionnaire
satisfaction and preference of device questionnaire

Full Information

First Posted
May 27, 2016
Last Updated
June 1, 2016
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02788487
Brief Title
Randomized Cross-over TRD and CPAP for OSA
Official Title
A Randomized Cross-over Study of Tongue Retaining Device and Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP1 use and TRD 2use
Arm Type
Active Comparator
Arm Description
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
Arm Title
TRD1 use and CPAP2 use
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Tongue retaining device
Intervention Description
Tongue retaining device is used for 3 weeks
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
Continuous positive airway pressure
Intervention Description
CPAP is used for 3 weeks
Primary Outcome Measure Information:
Title
apnea-hypopnea index (AHI)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Functional outcomes of sleep questionnaire (FOSQ ) score
Time Frame
3 weeks
Title
Epworth sleepiness score (ESS) scores
Time Frame
3 weeks
Title
lowest oxygen saturation during sleep test at home
Time Frame
3 weeks
Title
side effects questionnaire
Time Frame
3 weeks
Title
satisfaction and preference of device questionnaire
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: OSA patients aged over 18 years old at Siriraj hospital Apnea-hypopnea index (AHI) 5 - 30 events/ h or AHI > 30 events/h but lowest Oxygen saturation > 70% Positive consented form Exclusion Criteria: Patients with severe periodontal diseases Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, cancers, cerebrovascular diseases, epilepsy, dementia, etc. total sleep time less than 2 hour during previous sleep study Patients who could not tolerate the side effects of CPAP or TRD Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wish - Banhiran, MD
Phone
6699756405
Email
wishbanh@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anuch - Durongphan, MD
Phone
662 419 8040
Email
anuch.mai@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anuch - Durongphan, MD
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wish - Banhiran, MD
Phone
6624198040
Email
wishbanh@hotmail.com
First Name & Middle Initial & Last Name & Degree
wish - banhiran, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31754961
Citation
Banhiran W, Durongphan A, Keskool P, Chongkolwatana C, Metheetrairut C. Randomized crossover study of tongue-retaining device and positive airway pressure for obstructive sleep apnea. Sleep Breath. 2020 Sep;24(3):1011-1018. doi: 10.1007/s11325-019-01942-z. Epub 2019 Nov 21.
Results Reference
derived

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Randomized Cross-over TRD and CPAP for OSA

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