CPAP Improves the Walking Capacity in Patients With COPD and OSA

Chang Gung Medical Foundation

Status: Completed

Conditions: Walking Capacity

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01915641

101-5303B

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

group A

Active Comparator group

Description:

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

Treatment:

Device: CPAP

group B

Sham Comparator group

Description:

group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement

Treatment:

Device: CPAP