The Outcome of CPAP Titration Under Sleep Endoscopy

Obstructive Sleep Apnea Clinical Trial

Official title:

The Outcome of CPAP Titration Under Sleep Endoscopy: A Randomized Controlled Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523013
• Other study ID #: 201701422A3
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial

Description:

This is the study entitled "The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is about 50%. One of the reasons responsible for the poor compliance is the inadequate pressure setting initially. Therefore, it is crucial for us to find out the adequate pressure as soon as possible. Sleep endoscopy is the way to evaluate upper airway obstruction of OSA patients. Meanwhile, the investigators used CPAP to titrate the adequate pressure to keep upper airway open under sleep endoscopy guidance. While the investigators find out this adequate pressure, the investigators set this pressure into CPAP program, which OSA patient will use for 1 month. To compare the different effect of CPAP under either auto-CPAP titration pressure or sleep endoscopy guidance pressure, those OSA patients will use auto-titration CPAP for 1 month as well. Another highlight of this study is the sedative agent-dexmedetomidine. Dexmedetomidine is a α2 antogonist, which cause patients sedative but less respiratory drive suppression. The mechanism of dexmedetomidine is more physiological for nature sleep.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• moderate to severe OSA

• ESS >10

Exclusion Criteria:

• ASA > 3

• allergy to Dexmedetomidine

• second or third degree AVB

• severe heart failure Fc class IV

• asthma acute attack

Related Conditions & MeSH terms

• CPAP
• DISE
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
CPAP treatment with different pressure for OSA patients

Locations

Country	Name	City	State
Taiwan	Division of Thoracic Medicine, Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sleep quality	PSQ	the change of PSQ between baseline, 1 month and 2 months
Primary	complaince of CPAP use	CPAP complaince was defined as the use of CPAP is more than 4 hours per day and 5 days per week	the change of complaince between baseline, 1 month and 2 months
Secondary	sleepiness score	ESS	the change of ESS between baseline, 1 month and 2 months