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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.


Clinical Trial 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 Design

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


Related Conditions & MeSH terms


NCT number NCT01915641
Study type Interventional
Source Chang Gung Memorial Hospital
Contact
Status Completed
Phase N/A
Start date April 2013

See also
  Status Clinical Trial Phase
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