NCT01033266

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2014

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

5.1 years

First QC Date

December 15, 2009

Last Update Submit

April 9, 2020

Conditions

Obstructive Sleep ApneaChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Efficacy of nasal CPAP on CPET performance in patients with overlap syndrome

    2 years

Study Arms (1)

CPET CPAP

Diagnostic Test: CPET

Interventions

CPETDIAGNOSTIC_TEST

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

CPET CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with OSA and COPD will perform CPET before and after use of CPAP.

You may qualify if:

  • Obstructive sleep apnea (OSA)
  • COPD

You may not qualify if:

  • Inability to perform exercise test due to musculoskeletal limitation
  • Cardiac condition preventing patient from mild exercise
  • Continuous oxygen supplement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructivePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gary Kinasewitz, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

  • Houssein Youness, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2009

First Posted

December 16, 2009

Study Start

February 1, 2009

Primary Completion

February 28, 2014

Study Completion

February 28, 2014

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations

US(2)