CPAP Improves the Walking Capacity in Patients With COPD and OSA

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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CPAP Improves the Walking Capacity in Patients With COPD and OSA

Conditions
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Walking Capacity

Intervention / Treatment
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* Device: CPAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>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<br>* 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<br>* Other names: continuous positive airway pressure;|
| Sham Comparator: group B<br>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<br>* 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<br>* Other names: continuous positive airway pressure;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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walking capacity, COPD, OSA, CPAP