The Outcome of CPAP Titration Under Sleep Endoscopy

Chang Gung Medical Foundation

Status: Completed

Conditions: DISE; CPAP; Obstructive Sleep Apnea

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03523013

201701422A3

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

CPAP pressure (determied by DISE)

Experimental group

Treatment:

Device: CPAP

CPAP pressure (determined by physician)

Active Comparator group

Treatment:

Device: CPAP