Randomized Cross-over TRD and CPAP for OSA

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Tongue retaining device
* Device: CPAP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP1 use and TRD 2use<br>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<br>* Tongue retaining device is used for 3 weeks<br>Device: CPAP<br>* CPAP is used for 3 weeks<br>* Other names: Continuous positive airway pressure;|
| Experimental: TRD1 use and CPAP2 use<br>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<br>* Tongue retaining device is used for 3 weeks<br>Device: CPAP<br>* CPAP is used for 3 weeks<br>* Other names: Continuous positive airway pressure;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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