NCT02788487

Randomized Cross-over TRD and CPAP for OSA

A Randomized Cross-over Study of Tongue Retaining Device and Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (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 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Tongue retaining device	Tongue retaining device is used for 3 weeks
DEVICE	CPAP	CPAP is used for 3 weeks

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-12-01
• Completion: 2017-05-01
• First posted: 2016-06-02
• Last updated: 2016-06-02

Locations

1 site across 1 country: Thailand