The Outcome of CPAP Titration Under Sleep Endoscopy

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03523013
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.9
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea; CPAP; DISE	Device: CPAP	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: The Outcome of CPAP Titration Under Sleep Endoscopy: A Randomized Controlled Crossover Trial
• Actual Study Start Date: Feb 1, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPAP pressure (determied by DISE)	Device: CPAP; CPAP treatment with different pressure for OSA patients
Active Comparator: CPAP pressure (determined by physician)	Device: CPAP; CPAP treatment with different pressure for OSA patients

Outcome Measures

Primary Outcome Measures

1. complaince of CPAP use [the change of complaince between baseline, 1 month and 2 months]

   CPAP complaince was defined as the use of CPAP is more than 4 hours per day and 5 days per week

Secondary Outcome Measures

1. sleepiness score [the change of ESS between baseline, 1 month and 2 months]

   ESS

Other Outcome Measures

1. sleep quality [the change of PSQ between baseline, 1 month and 2 months]

   PSQ

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Thoracic Medicine, Chang Gung Memorial Hospital	Taipei		Taiwan	105

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03523013
• Other Study ID Numbers: 201701422A3
• First Posted: May 14, 2018
• Last Update Posted: Sep 30, 2020
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Apnea, Obstructive

Study Results

No Results Posted as of Sep 30, 2020