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 January 2014 by University of Oklahoma
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01033266
First received: December 15, 2009
Last updated: January 6, 2014
Last verified: January 2014
  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:


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: December 2016
Estimated Primary Completion Date: December 2015 (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: January 6, 2014
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 April 16, 2014