Compare Outcomes of SMG and CPAP in 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 Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 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 Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 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 2 weeks and Wash-out periods 2 weeks are required before start each treatment.

Official Title
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A Randomized Cross-over Study of Adjustable Thermoplastic Oral Appliances and Continuous Positive Airway Pressure in Treatment of Patients With Obstructive Sleep Apnea

Conditions
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Quality of Life, Sleep Apnea Syndromes

Intervention / Treatment
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* Device: CPAP
* Device: Somnoguard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OSA patients aged over 18 YO at Siriraj hospital AHI 5 - 30 events/ h or AHI > 30 events/h but lowest O2 saturation > 70% Positive consented form Exclusion Criteria: Patients with severe Temporomandibular joint diseases or limited mandible advancement (< 5 mm) Patients with severe periodontal diseases or inadequate teeth (< 3 teeth in each quadrant) Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, COPD, cancers, cerebrovascular diseases, epilepsy, dementia, etc. Patients who could not tolerate the side effects of CPAP or SMG 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: CPAP Therapy<br>Continuous Positive Airway Pressure | Device: CPAP<br>* CPAP is used for 6 weeks<br>* Other names: Continuous positive airway pressure therapy;|
| Experimental: Somnoguard<br>Somnoguard | Device: Somnoguard<br>* Somnoguard is used for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | FOSQ scores | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects | questionnaires | 6 weeks | 
| satisfaction | VAS scores | 6 weeks | 
| AHI | Apnea-hypopnea index (events per hour) | 6 weeks | 
| Degree of sleepiness | ESS scores | 6 weeks | 
| lowest oxygen saturation | lowest oxygen saturation (%) | 6 weeks |