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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01033266
Other study ID # 14587/2895
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2009
Est. completion date February 28, 2014

Study information

Verified date April 2020
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Nasal CPAP will improve cardiopulmonary exercise test (CPET) performance in patients with overlap syndrome(COPD and OSA). Nasal CPAP is proven to improve cardiopulmonary exercise testing in patients with OSA. The investigators hypothesis is that patients with overlap syndrome will have a greater improvement in their cardiopulmonary exercise testing besides a possible improvement in their lung function test and airway resistance.


Description:

Patients presenting to the Oklahoma City VA sleep clinic with obstructive sleep apnea syndrome and a desire to initiate CPAP treatment will be included if they have overlap syndrome. Patients will undergo a spirometry and CPET before being started on CPAP as part of standard clinical care. The CPET will be repeated after 8-12 weeks of CPAP use. Patients will be excluded if they have any contraindication to mild exercise or they cannot perform an exercise test due to limited mobility.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date February 28, 2014
Est. primary completion date February 28, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Obstructive sleep apnea (OSA)

- COPD

Exclusion Criteria:

- Inability to perform exercise test due to musculoskeletal limitation

- Cardiac condition preventing patient from mild exercise

- Continuous oxygen supplement

Study Design


Intervention

Diagnostic Test:
CPET
CPET will be done on patients with overlap syndrome before and after clinical CPAP treatment.

Locations

Country Name City State
United States OU Medical Center Oklahoma City Oklahoma
United States VA Medical Center Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of nasal CPAP on CPET performance in patients with overlap syndrome 2 years
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