Quality of Life, Sleep Apnea Syndromes
Conditions
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.
Interventions
DEVICECPAP
CPAP is used for 6 weeks
DEVICESomnoguard
Somnoguard is used for 6 weeks
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 6 weeks | FOSQ scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
Countries
Thailand
Contacts
Primary ContactWish Banhiran, MD
Outcome results
None listed