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CPAP Improves the Walking Capacity in Patients With COPD and OSA

Chang Gung Medical Foundation logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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