Sleep Apnea, ObstructiveNCT01317329
"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"
A study testing Clinically prescribed CPAP therapy in people with Sleep Apnea, Obstructive and Hypoxia, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine the factors that are associated with improved cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to severe obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Hypoxia, Hypercapnia
- What is being tested?
- Clinically prescribed CPAP therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2014
- Phase
- Interventional
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subjects naïve of CPAP therapy just recently diagnosed with moderate to severe obstructive sleep apnea (OSA). The degree of OSA is defined by results of a comprehensive polysomnogram requiring an apnea hypopnea index (AHI) >15 events/hour and Epworth score >10, or an AHI >20 events/hour
- either sex
- any race
- between 21-50 years old.
Who cannot join
- Systolic blood pressure >160 mmHg, or diastolic blood pressure >100 mmHg
- Changes in antihypertensive medications in the last 6 weeks
- Restless leg syndrome
- Average overnight oxygen saturation below 80%
- Current use of beta-blockers
- History of coronary artery disease
Show all 18Show fewer
- History of Stroke
- Atrial fibrillation
- Peripheral vascular disease
- Suspected cardiac valve abnormality
- Ejection fraction <50%
- Type I and type II Diabetes Mellitus (DM)
- Asthma or confirmed Chronic Obstructive Pulmonary Disease
- Cigarette smoking in the last 6 months
- Raynaud's disease
- Pregnancy (the normal hormonal changes that occur in pregnancy affect greatly arterial stiffness parameters) If a subject becomes pregnant we will discontinue data collection.
- Physically incapable of resting on left lateral decubitus for 40 minutes.
- Mastectomy with lymph node removal that might preclude us to monitor blood pressures on both arms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Reversibility of Cardiovascular Injury With Continuous Positive Airway Pressure (CPAP) Use: Mechanisms Involved"
The purpose of this study is to determine the factors that are associated with improved cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to severe obstructive sleep apnea.
Read the detailed description
We will monitor non-invasively changes in arterial stiffness, cardiac mass, pulmonary pressures, endothelial function, etc. We will also assess the reversibility of these changes after only 5-7 days of not using the CPAP mask. In a subgroup of subjects we will explore changes in coronary flow response after 12 weeks of CPAP use compared with baseline.
- Conditions
- Sleep Apnea, Obstructive, Hypoxia, Hypercapnia, Sleep Disorders, Obesity, Hypertension
- Being tested
- Clinically prescribed CPAP therapy
- Medical subject headings
- Sleep Apnea, Obstructive, Hypoxia, Hypercapnia, Sleep Wake Disorders, Obesity, Hypertension, Coronary Vasospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinically prescribed CPAP therapyOther
CPAP as prescribed by attending physician
| Study group | Role | What they receive |
|---|---|---|
| Clinically prescribed CPAP therapy | Other | Clinically prescribed CPAP therapy Receives: Other: Clinically prescribed CPAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy
Ultrasound based brachial artery reactivity tests will be performed at entry before CPAP therapy and at 4, 12 weeks post CPAP use and 5-7 days after CPAP withdrawal
Measured: 14 weeks
Secondary outcomes (2)
Changes in arterial stiffness between baseline and after CPAP treatment
Subjects will undergo pulse wave velocity testing with applanation tonometry. tonometry recordings will be at entry and after 4 and 12 weeks of CPAP use and 5-7- days after withdrawal.
Measured: 14 weeks
Changes in coronary artery flow under a cold pressor test
A subset of subjects with abnormal endothelial function determined during the baseline scan and good echocardiographic images will be invited to participate on this portion of the test. We will record the response to a cold pressor test (submerging their hand in ice water for 1.5 minutes) on left anterior descending coronary artery velocities with transthoracic echocardiography at baseline and after 12 weeks of CPAP therapy.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia E Korcarz, DVM, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317329
- Sponsor's protocol ID
- K23HL094760
- Status last verified
- Sep 2015
- First submitted
- 14 Mar 2011
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Korcarz CE, Benca R, Barnet JH, Stein JH. Treatment of Obstructive Sleep Apnea in Young and Middle-Aged Adults: Effects of Positive Airway Pressure and Compliance on Arterial Stiffness, Endothelial Function, and Cardiac Hemodynamics. J Am Heart Assoc. 2016 Apr 3;5(4):e002930. doi: 10.1161/JAHA.115.002930.
PubMed 27039928
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Reversibility of Cardiovascular Injury With Continuous Positive Airway Pressure (CPAP) Use: Mechanisms Involved"
- ClinicalTrials.gov ID
- NCT01317329
- Acronym / sponsor ID
- K23HL094760
- Conditions
- Sleep Apnea, Obstructive, Hypoxia, Hypercapnia, Sleep Disorders, Obesity, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Mar 2011 (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.
The purpose of this study is to determine the factors that are associated with improved cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to severe obstructive sleep apnea.
Detailed description
We will monitor non-invasively changes in arterial stiffness, cardiac mass, pulmonary pressures, endothelial function, etc. We will also assess the reversibility of these changes after only 5-7 days of not using the CPAP mask. In a subgroup of subjects we will explore changes in coronary flow response after 12 weeks of CPAP use compared with baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinically prescribed CPAP therapy | Other | Other: Clinically prescribed CPAP therapyClinically prescribed CPAP therapy |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- subjects naïve of CPAP therapy just recently diagnosed with moderate to severe obstructive sleep apnea (OSA). The degree of OSA is defined by results of a comprehensive polysomnogram requiring an apnea hypopnea index (AHI) >15 events/hour and Epworth score >10, or an AHI >20 events/hour
- either sex
- any race
- between 21-50 years old.
Key exclusion criteria (18 listed)
- Systolic blood pressure >160 mmHg, or diastolic blood pressure >100 mmHg
- Changes in antihypertensive medications in the last 6 weeks
- Restless leg syndrome
- Average overnight oxygen saturation below 80%
- Current use of beta-blockers
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 |
|---|---|---|
| Clinically prescribed CPAP therapyCPAP as prescribed by attending physician | Other | Clinically prescribed CPAP therapy |
Primary outcome
Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy
Time frame: 14 weeks
Ultrasound based brachial artery reactivity tests will be performed at entry before CPAP therapy and at 4, 12 weeks post CPAP use and 5-7 days after CPAP withdrawal
2 secondary outcomes
Changes in arterial stiffness between baseline and after CPAP treatment
Time frame: 14 weeks
Changes in coronary artery flow under a cold pressor test
Time frame: 13 weeks
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 6 Mar 2020.
- Derived from this study: PubMed 27039928Korcarz CE, Benca R, Barnet JH, Stein JH. Treatment of Obstructive Sleep Apnea in Young and Middle-Aged Adults: Effects of Positive Airway Pressure and Compliance on Arterial Stiffness, Endothelial Function, and Cardiac Hemodynamics. J Am Heart Assoc. 2016 Apr 3;5(4):e002930. doi: 10.1161/JAHA.115.002930.
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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.
Claudia E Korcarz, DVM principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinically prescribed CPAP therapy in people with Sleep Apnea, Obstructive and Hypoxia, run by University of Wisconsin, Madison at 1 site 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 4 inclusion and 18 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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01317329, which also lists 1 linked publication.
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 6 Mar 2020.