Obstructive Sleep ApneaNCT01033266
Effect of Nasal CPAP on Cardiopulmonary Exercise Testing in Patients With Overlap Syndrome
An observational study of Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease, run by University of Oklahoma at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease
- What is being tested?
- CPET
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2009to 28 Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with OSA and COPD will perform CPET before and after use of CPAP.
Who may be able to join
- Obstructive sleep apnea (OSA)
- COPD
Who cannot join
- Inability to perform exercise test due to musculoskeletal limitation
- Cardiac condition preventing patient from mild exercise
- Continuous oxygen supplement
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OU Medical Center
Oklahoma City, Oklahoma, 73104
VA Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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)
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.
Read the detailed 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.
- Being tested
- CPET
- Medical subject headings
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPETDiagnostic test
CPET will be done on patients with overlap syndrome before and after clinical CPAP treatment.
| Study group | Role | What they receive |
|---|---|---|
| CPET CPAP | Not described Receives: Diagnostic Test: CPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of nasal CPAP on CPET performance in patients with overlap syndrome
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study start1 Feb 2009
- Primary completion28 Feb 2014
- Study completion28 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Kinasewitz, MD, Principal investigator, University of OklahomaHoussein Youness, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033266
- Sponsor's protocol ID
- 14587/2895
- Status last verified
- Apr 2020
- First submitted
- 15 Dec 2009
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01033266
- Acronym / sponsor ID
- 14587/2895
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Feb 2009 (actual)
- Primary completion
- 28 Feb 2014 (actual)
- Study completion
- 28 Feb 2014 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPET CPAP | – | Diagnostic Test: CPET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with OSA and COPD will perform CPET before and after use of CPAP.
Key inclusion criteria (2 listed)
- Obstructive sleep apnea (OSA)
- COPD
Key exclusion criteria (3 listed)
- Inability to perform exercise test due to musculoskeletal limitation
- Cardiac condition preventing patient from mild exercise
- Continuous oxygen supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPETCPET will be done on patients with overlap syndrome before and after clinical CPAP treatment. | Diagnostic test | CPET CPAP |
Primary outcome
Efficacy of nasal CPAP on CPET performance in patients with overlap syndrome
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Kinasewitz, MD principal investigator
University of Oklahoma
Houssein Youness, MD principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of nasal CPAP on CPET performance in patients with overlap syndrome (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.