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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
CPAP is used for 6 weeks
Somnoguard is used for 6 weeks
Siriraj Hospital
Bangkok, Bangkok, Thailand
RECRUITINGQuality of life
FOSQ scores
Time frame: 6 weeks
side effects
questionnaires
Time frame: 6 weeks
satisfaction
VAS scores
Time frame: 6 weeks
AHI
Apnea-hypopnea index (events per hour)
Time frame: 6 weeks
Degree of sleepiness
ESS scores
Time frame: 6 weeks
lowest oxygen saturation
lowest oxygen saturation (%)
Time frame: 6 weeks
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