Obstructive Sleep ApneaOSA-MRINCT01136122
Effects of PAP Treatment of OSA in Patients With Heart Failure
A study testing CPAP Treatment in people with Obstructive Sleep Apnea, run by Ulysses Magalang MD at 1 site in United States.
Trial summary
The purpose of this study is to see if treatment of OSA with the CPAP device makes a difference to insulin resistance and heart disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and < 75 years of age.
- Apnea-hypopnea index (AHI) of at least 15/hr based on overnight polysomnography.
- New York Heart Association Class 3 or less.
- LV ejection fraction <45% based on a prior imaging study (as measured within one year of baseline studies).
- Absence of exacerbation of heart failure requiring hospitalization within the previous 3 mos.
- Optimal pharmacologic therapy at the highest tolerated dose [3].
Who cannot join
- Use of anti-diabetic medications
- Primary valvular heart disease
- Unstable angina
- Myocardial infarction, cardiac surgery, or revascularization procedure within the previous 3 months
- Uncontrolled hypertension defined as systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg.
- Active smoking (Patient should not have smoked for at least 1 month prior to baseline studies and has the intention not to smoke for the duration of the study period)
Show all 14Show fewer
- Use of illicit drugs
- Current use of home oxygen therapy
- Requirement for a bi-level machine to treat sleep apnea
- Use of corticosteroids
- Creatinine clearance < 30ml/min (calculated from serum creatinine)
- Pregnant women will be excluded as pregnancy interferes with glucose and adiponectin. Additionally the contrast used in the cardiac MRIs may be harmful to unborn babies. Females of child bearing potential must agree to use effective contraception during the trial.
- Any contraindication to CMR (Cardiovascular magnetic resonance) imaging such as ferromagnetic foreign body, orbital metal, cerebral aneurysm clip, pacemaker, defibrillator, neurostimulator, allergy to gadolinium-based contrast, or severe claustrophobia. The standard FDA and OSUMC's screening guidelines for MRI safety will be followed.
- Inability or unwillingness to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43221
About this study
Official title: Effects of Positive Airway Pressure (PAP) Treatment of Obstructive Sleep Apnea (OSA) in Patients With Heart Failure
The purpose of this study is to see if treatment of OSA with the CPAP device makes a difference to insulin resistance and heart disease.
Read the detailed description
Obstructive Sleep Apnea (OSA) has been seen frequently in persons who develop insulin resistance and heart disease. Insulin resistance is a condition in which the body produces insulin but does not use it properly. Insulin helps the body use glucose for energy. Insulin resistance increases the chance of developing type II diabetes and heart disease.
One method of treatment for OSA is with continuous positive airway pressure (CPAP). This treatment is given by a device named CPAP. There are many different types of CPAPs available on the market that are FDA approved.
The purpose of this study is to see if treatment of OSA with the CPAP device makes a difference to insulin resistance and heart disease. This study will measure insulin resistance by testing the glucose level in the blood, and testing the levels of special protein found in blood, that are known to increase the sensitivity to insulin and decrease progression of heart disease. The heart disease will be measured by cardiac MRI. Glucose testing and cardiac MRI's are normal testing procedures for people who have OSA and heart disease, however will be conducted more frequently than normal and therefore are for research purposes. The specialized blood testing is for research purposes only.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP Treatment
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP TreatmentDevice
Also called CPAP
Effective CPAP treatment for one month
| Study group | Role | What they receive |
|---|---|---|
| CPAP Arm | Active comparator | Receive effective CPAP treatment for one month Receives: Device: CPAP Treatment |
| Control Arm | No intervention | Receive no treatment for one month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in circulating levels of adiponectin (Ad) and/or high-molecular-weight (HMW) Ad.
Measured: One month
Secondary outcomes (1)
Increased levels of Ad and/or HMW Ad associate with improvements in insulin sensitivity and heart function in patients with known left ventricular (LV) systolic dysfunction.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2013
- Study completionOct 2013
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulysses Magalang MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulysses Magalang MD, Ohio State University
- Investigators
- Ulysses Magalang, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136122
- Sponsor's protocol ID
- 2009H0304
- Acronym
- OSA-MRI
- Status last verified
- Apr 2016
- First submitted
- 17 May 2010
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positive Airway Pressure (PAP) Treatment of Obstructive Sleep Apnea (OSA) in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01136122
- Acronym / sponsor ID
- OSA-MRI / 2009H0304
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ulysses Magalang MDUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 3 Jun 2010 (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 see if treatment of OSA with the CPAP device makes a difference to insulin resistance and heart disease.
Detailed description
Obstructive Sleep Apnea (OSA) has been seen frequently in persons who develop insulin resistance and heart disease. Insulin resistance is a condition in which the body produces insulin but does not use it properly. Insulin helps the body use glucose for energy. Insulin resistance increases the chance of developing type II diabetes and heart disease.
One method of treatment for OSA is with continuous positive airway pressure (CPAP). This treatment is given by a device named CPAP. There are many different types of CPAPs available on the market that are FDA approved.
The purpose of this study is to see if treatment of OSA with the CPAP device makes a difference to insulin resistance and heart disease. This study will measure insulin resistance by testing the glucose level in the blood, and testing the levels of special protein found in blood, that are known to increase the sensitivity to insulin and decrease progression of heart disease. The heart disease will be measured by cardiac MRI. Glucose testing and cardiac MRI's are normal testing procedures for people who have OSA and heart disease, however will be conducted more frequently than normal and therefore are for research purposes. The specialized blood testing is for research purposes only.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP Arm | Active comparator | Device: CPAP TreatmentReceive effective CPAP treatment for one month |
| Control Arm | No intervention | –Receive no treatment for one month |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 and < 75 years of age.
- Apnea-hypopnea index (AHI) of at least 15/hr based on overnight polysomnography.
- New York Heart Association Class 3 or less.
- LV ejection fraction <45% based on a prior imaging study (as measured within one year of baseline studies).
- Absence of exacerbation of heart failure requiring hospitalization within the previous 3 mos.
Key exclusion criteria (14 listed)
- Use of anti-diabetic medications
- Primary valvular heart disease
- Unstable angina
- Myocardial infarction, cardiac surgery, or revascularization procedure within the previous 3 months
- Uncontrolled hypertension defined as systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg.
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 |
|---|---|---|
| CPAP TreatmentAlso: CPAPEffective CPAP treatment for one month | Device | CPAP Arm |
Primary outcome
Increase in circulating levels of adiponectin (Ad) and/or high-molecular-weight (HMW) Ad.
Time frame: One month
1 secondary outcome
Increased levels of Ad and/or HMW Ad associate with improvements in insulin sensitivity and heart function in patients with known left ventricular (LV) systolic dysfunction.
Time frame: One month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Ulysses Magalang, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP Treatment in people with Obstructive Sleep Apnea, run by Ulysses Magalang MD 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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 20 Oct 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Increase in circulating levels of adiponectin (Ad) and/or high-molecular-weight (HMW) Ad. (time frame: One month). 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 20 Oct 2025.