CPAP Improves the Walking Capacity in Patients With COPD and OSA

November 20, 2016 updated by: Chang Gung Memorial Hospital

We have reported that CPAP treatment improved the walking capacity of overlap syndrome patients.

However, the previous study was not randomized, double blinded study. Therefore, we design a prospective, randomized, double blinded, controlled, cross-over trial to confirm this finding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

inclusion criteria :

  • COPD : FEV1/FVC < 70%, no response to bronchodilator (FEV1 change <12% and <200ml)
  • OSA : AHI > 15/h, obstructive type predominant

exclusion criteria :

  • any malignancy
  • pregnancy
  • claustrophobia
  • age<18

primary outcome : exercise capacity (walking distance (meter), measured by incremental shuttle walking test)

Method : For those fit in criteria. CPAP titration will be performed to determine the optimal pressure Baseline measurement : incremental shuttle walking test, urine catecholamine, heart rate variability, muscle power and other baseline characteristics Randomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Department of Thoracic Medicine, Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • FEV1/FVC < 70%, no response to bronchodilator (FEV1 change <12% and <200ml)
  • OSA : AHI > 15/h, obstructive type predominant

Exclusion Criteria:

  • any malignancy
  • pregnancy
  • claustrophobia
  • age<18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: group A
group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement
Device: CPAP
Randomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement
Other Names:
  • continuous positive airway pressure
SHAM_COMPARATOR: group B
group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement
Device: CPAP
Randomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement
Other Names:
  • continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
exercise capacity (walking distance (meter), measured by incremental shuttle walking test)
Time Frame: CPAP treatment for 1 month
CPAP treatment for 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: TSAI-YU WANG, MD, Department of Thoracic Medicine, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

July 28, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (ESTIMATE)

August 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 20, 2016

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 101-5303B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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