Compare Outcomes of SMG and CPAP in OSA

Not Applicable

• Conditions: Quality of Life; Sleep Apnea Syndromes
• Interventions: Device: CPAP; Device: Somnoguard

• Registration Number: NCT02766179
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Status Verified: 2016-05
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-06
• Last Update Submitted: 2016-05-06
• Study First Posted: 2016-05-09
• Last Update Posted: 2016-05-09
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. OSA patients aged over 18 YO at Siriraj hospital
2. AHI 5 - 30 events/ h or AHI > 30 events/h but lowest O2 saturation > 70%
3. Positive consented form

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Exclusion Criteria

1. Patients with severe Temporomandibular joint diseases or limited mandible advancement (< 5 mm)
2. Patients with severe periodontal diseases or inadequate teeth (< 3 teeth in each quadrant)
3. Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, COPD, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
4. Patients who could not tolerate the side effects of CPAP or SMG
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
CPAP Therapy	CPAP	Continuous Positive Airway Pressure
Somnoguard	Somnoguard	Somnoguard

Primary Outcome Measures

Name	Time	Method
Quality of life	6 weeks	FOSQ scores

Secondary Outcome Measures

Name	Time	Method
side effects	6 weeks	questionnaires
satisfaction	6 weeks	VAS scores
AHI	6 weeks	Apnea-hypopnea index (events per hour)
Degree of sleepiness	6 weeks	ESS scores
lowest oxygen saturation	6 weeks	lowest oxygen saturation (%)

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand