The Outcome of CPAP Titration Under Sleep Endoscopy

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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; CPAP; DISE
• Intervention / Treatment: Device: CPAP

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 105
    • Division of Thoracic Medicine, Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleepiness score	ESS	the change of ESS between baseline, 1 month and 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep quality	PSQ	the change of PSQ between baseline, 1 month and 2 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 201701422A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No