NCT02766179

Compare Outcomes of SMG and CPAP in OSA

A Randomized Cross-over Study of Adjustable Thermoplastic Oral Appliances and Continuous Positive Airway Pressure in Treatment of Patients With Obstructive Sleep Apnea

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Quality of Life
• Sleep Apnea Syndromes

Interventions

Type	Name	Description
DEVICE	CPAP	CPAP is used for 6 weeks
DEVICE	Somnoguard	Somnoguard is used for 6 weeks

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-05-09
• Last updated: 2016-05-09

Locations

1 site across 1 country: Thailand