NCT01915641

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

April 1, 2013

Enrollment Period

3.6 years

First QC Date

July 28, 2013

Last Update Submit

November 20, 2016

Conditions

Walking Capacity

Keywords

walking capacityCOPDOSACPAP

Outcome Measures

Primary Outcomes (1)

  • exercise capacity (walking distance (meter), measured by incremental shuttle walking test)

    CPAP treatment for 1 month

Study Arms (2)

group A

ACTIVE COMPARATOR

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

group B

SHAM COMPARATOR

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

Interventions

CPAPDEVICE

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

Also known as: continuous positive airway pressure
group Agroup B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FEV1/FVC \< 70%, no response to bronchodilator (FEV1 change \<12% and \<200ml)
  • OSA : AHI \> 15/h, obstructive type predominant

You may not qualify if:

  • any malignancy
  • pregnancy
  • claustrophobia
  • age\<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • TSAI-YU WANG, MD

    Department of Thoracic Medicine, Chang Gung Memorial Hospital 199 Tun-Hwa N. Rd., Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

  • TSAI-YU WANG, MD

    Department of Thoracic Medicine, Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2013

First Posted

August 5, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2016

Last Updated

November 22, 2016

Record last verified: 2013-04

Locations

TW(1)