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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03523013
Other study ID # 201701422A3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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