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New study aims to crack the code on Hard-to-Treat sleep apnea in heart failure

NCT ID NCT07210606

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 looks at why people with heart failure or those taking opioid painkillers develop central sleep apnea (pauses in breathing during sleep). Current treatments don't work well, so researchers will test combinations of breathing machines and medications in 200 Veterans. The goal is to understand the root causes and guide future therapies.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Men and Women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)\>15/hour with CAHI\>5/hour, will be included with the experiments. * Those with chronic, stable heart failure with reduced ejection fraction, receiving stable optimized guideline-based therapy and no hospitalizations or change in the medical regimen for the past 90 days before enrollment. Exclusion Criteria: * less than 18 years old * pregnant or breastfeeding females * moderate or severe obstructive or restrictive lung disease, including supplemental o2 use * current treatment for CSA, including any form of PAP in the past three months, or phrenic nerve situation. * too ill to engage in the study procedures, inability to provide consent for participation. * a history of cardiac arrhythmia * Alcohol or substance abuse (less than 90 days sobriety) or current participation in a treatment program * depression or a history of suicidality * severe insomnia (ISI\>21) or reported short sleep duration (\<6 hours) * PAP-emergent central sleep apnea * Lack of PAP acceptance/adherence after a one-week home PAP trial after enrollment. Additional Trazodone Exclusions: * Prolonged QT on baseline ECG, using medications that inhibit CYP3A4 * Patients with severe renal impairment (GFR \< 20ml/min/1.73m2) or end-stage renal disease

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • John D. Dingell VA Medical Center, Detroit, MI

    Detroit, Michigan, 48201-1916, United States

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