Compare Outcomes of SMG and CPAP in OSA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-12-31

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.

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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.

Conditions

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Quality of Life Sleep Apnea Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP Therapy

Continuous Positive Airway Pressure

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

CPAP is used for 6 weeks

Somnoguard

Group Type EXPERIMENTAL

Somnoguard

Intervention Type DEVICE

Somnoguard is used for 6 weeks

Interventions

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CPAP

CPAP is used for 6 weeks

Intervention Type DEVICE

Somnoguard

Somnoguard is used for 6 weeks

Intervention Type DEVICE

Other Intervention Names

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Continuous positive airway pressure therapy

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No