CPAP Improves the Walking Capacity in Patients With COPD and OSA

Walking Capacity Clinical Trial

Official title:

CPAP Improves the Walking Capacity in Patients With COPD and OSA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915641
• Other study ID #: 101-5303B
• Status: Completed
• Phase: N/A
• First received: July 28, 2013
• Last updated: November 20, 2016
• Start date: April 2013

Study information

• Verified date: April 2013
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTaiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Walking Capacity

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Thoracic Medicine, Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise capacity (walking distance (meter), measured by incremental shuttle walking test)		CPAP treatment for 1 month	No