Effect of Continuous Positive Airway Pressure (CPAP) and Cardiopulmonary Exercise Testing(CPET) in Patient With Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD)
This study is currently recruiting participants.
Verified February 2013 by University of Oklahoma
Sponsor:
University of Oklahoma
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01033266
First received: December 15, 2009
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea Chronic Obstructive Pulmonary Disease |
Device: CPAP |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Nasal CPAP on Cardiopulmonary Exercise Testing in Patients With Overlap Syndrome |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Exercise and Physical Fitness
Sleep Apnea
U.S. FDA Resources
Further study details as provided by University of Oklahoma:
Primary Outcome Measures:
- Efficacy of nasal CPAP on CPET performance in patients with overlap syndrome [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| CPAP |
Device: CPAP
CPET will be done on patients with overlap syndrome before and after CPAP treatment
|
Detailed Description:
Patients will be included if they have overlap syndrome. Patients will undergo a spirometry and CPET before being started on CPAP. Those tests will be repeated after 8-12 weeks of CPAP use. Patients will be excluded if they have any contraindication to mild exercise or they can't perform an exercise test due to limited mobility.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033266
Contacts
| Contact: Gary Kinasewitz, MD | 405-271-6173 | gary-kinasewitz@ouhsc.edu |
| Contact: Ashley Ellis, BSN | ashley-ellis@ouhsc.edu |
Locations
| United States, Oklahoma | |
| VA Medical Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Gary Kinasewitz, M.D 405-271-6173 gary-kinasewitz@ouhsc.edu | |
| Contact: Houssein Youness, MD 405-271-6173 houssein-youness@ouhsc.edu | |
| OU Medical Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Gary Kinasewitz, M.D 405-271-6173 gary-kinasewitz@ouhsc.edu | |
| Contact: Houssein Youness, MD 405-271-6173 houssein-youness@ouhsc.edu | |
Sponsors and Collaborators
University of Oklahoma
Investigators
| Principal Investigator: | Gary Kinasewitz, MD | University of Oklahoma |
| Principal Investigator: | Houssein Youness, MD | University of Oklahoma |
More Information
No publications provided
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT01033266 History of Changes |
| Other Study ID Numbers: | 14587 |
| Study First Received: | December 15, 2009 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Apnea Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Sleep Apnea Syndromes Sleep Apnea, Obstructive Lung Diseases, Obstructive |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013