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Sleep apnea treatment study for heart patients cancelled

NCT ID NCT01136122

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to find out if treating obstructive sleep apnea with a CPAP machine could help improve insulin resistance and heart function in people with heart failure. It planned to enroll adults aged 18 to 75 with moderate to severe sleep apnea and reduced heart pumping ability. However, the study was withdrawn before any participants were enrolled, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Started

Apr 2010

Finished

Oct 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 \[3\]. Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Ohio State University Medical Center

    Columbus, Ohio, 43221, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.