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The Outcome of CPAP Titration Under Sleep Endoscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03523013
Enrollment
24
Registered
2018-05-14
Start date
2018-02-01
Completion date
2019-12-31
Last updated
2020-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CPAP, DISE, Obstructive Sleep Apnea

Brief summary

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

Detailed 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.

Interventions

DEVICECPAP

CPAP treatment with different pressure for OSA patients

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
complaince of CPAP usethe change of complaince between baseline, 1 month and 2 monthsCPAP complaince was defined as the use of CPAP is more than 4 hours per day and 5 days per week

Secondary

MeasureTime frameDescription
sleepiness scorethe change of ESS between baseline, 1 month and 2 monthsESS

Other

MeasureTime frameDescription
sleep qualitythe change of PSQ between baseline, 1 month and 2 monthsPSQ

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026