Obstructive Sleep Apnea
Conditions
Brief summary
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
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.
Interventions
DEVICETongue retaining device
Tongue retaining device is used for 3 weeks
DEVICECPAP
CPAP is used for 3 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 years old at Siriraj hospital 2. Apnea-hypopnea index (AHI) 5 - 30 events/ h or AHI \> 30 events/h but lowest Oxygen saturation \> 70% 3. Positive consented form
Exclusion criteria
1. Patients with severe periodontal diseases 2. Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, cancers, cerebrovascular diseases, epilepsy, dementia, etc. 3. total sleep time less than 2 hour during previous sleep study 4. Patients who could not tolerate the side effects of CPAP or TRD 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 |
|---|---|
| apnea-hypopnea index (AHI) | 3 weeks |
Secondary
| Measure | 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 |
Countries
Thailand
Contacts
Primary ContactWish - Banhiran, MD
Backup ContactAnuch - Durongphan, MD
Outcome results
None listed