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The Outcome of CPAP Titration Under Sleep Endoscopy

Primary Purpose

Obstructive Sleep Apnea, CPAP, DISE

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
CPAP
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Division of Thoracic Medicine, Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CPAP pressure (determied by DISE)

CPAP pressure (determined by physician)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

sleepiness score
ESS

Full Information

First Posted
March 26, 2018
Last Updated
September 29, 2020
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03523013
Brief Title
The Outcome of CPAP Titration Under Sleep Endoscopy
Official Title
The Outcome of CPAP Titration Under Sleep Endoscopy: A Randomized Controlled Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, CPAP, DISE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP pressure (determied by DISE)
Arm Type
Experimental
Arm Title
CPAP pressure (determined by physician)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP treatment with different pressure for OSA patients
Primary Outcome Measure Information:
Title
complaince of CPAP use
Description
CPAP complaince was defined as the use of CPAP is more than 4 hours per day and 5 days per week
Time Frame
the change of complaince between baseline, 1 month and 2 months
Secondary Outcome Measure Information:
Title
sleepiness score
Description
ESS
Time Frame
the change of ESS between baseline, 1 month and 2 months
Other Pre-specified Outcome Measures:
Title
sleep quality
Description
PSQ
Time Frame
the change of PSQ between baseline, 1 month and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Thoracic Medicine, Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
105
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35769360
Citation
Wang TY, Huang YC, Lin TY, Ni YL, Lo YL. Outcome of CPAP Titration for Moderate-to-Severe OSA Under Drug-Induced Sleep Endoscopy: A Randomized Controlled Crossover Trial. Front Neurol. 2022 Jun 13;13:882465. doi: 10.3389/fneur.2022.882465. eCollection 2022.
Results Reference
derived

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The Outcome of CPAP Titration Under Sleep Endoscopy

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