NCT03523013

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 30, 2020

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

March 26, 2018

Last Update Submit

September 29, 2020

Conditions

Obstructive Sleep ApneaCPAPDISE

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • sleepiness score

    the change of ESS between baseline, 1 month and 2 months

Other Outcomes (1)

  • sleep quality

    the change of PSQ between baseline, 1 month and 2 months

Study Arms (2)

CPAP pressure (determied by DISE)

EXPERIMENTAL
Device: CPAP

CPAP pressure (determined by physician)

ACTIVE COMPARATOR
Device: CPAP

Interventions

CPAPDEVICE

CPAP treatment with different pressure for OSA patients

CPAP pressure (determied by DISE)CPAP pressure (determined by physician)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate to severe OSA
  • ESS \>10

You may not qualify if:

  • ASA \> 3
  • allergy to Dexmedetomidine
  • second or third degree AVB
  • severe heart failure Fc class IV
  • asthma acute attack

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Thoracic Medicine, Chang Gung Memorial Hospital

Taipei, 105, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 35769360DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

May 14, 2018

Study Start

February 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 30, 2020

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)