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OpenTrials
Completed

NCT Number: NCT01915641

CPAP Improves the Walking Capacity in Patients With COPD and OSA

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.

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Key information

Conditions

Walking Capacity Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taipei, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

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

Primary outcomes

  1. exercise capacity (walking distance (meter), measured by incremental shuttle walking test)

    Time frame: CPAP treatment for 1 month

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
First posted
Aug 5, 2013
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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