Randomized Cross-over TRD and CPAP for OSA

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Tongue retaining device; Device: CPAP

• Registration Number: NCT02788487
• Lead Sponsor: Mahidol University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-06-01
• Last Update Submitted: 2016-06-01
• Study First Posted: 2016-06-02
• Last Update Posted: 2016-06-02
• Primary Completion: 2016-12
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPAP1 use and TRD 2use	CPAP	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
TRD1 use and CPAP2 use	Tongue retaining device	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
TRD1 use and CPAP2 use	CPAP	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
CPAP1 use and TRD 2use	Tongue retaining device	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

Primary Outcome Measures

Name	Time	Method
apnea-hypopnea index (AHI)	3 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand