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Sleep coaching shows promise for heart failure patients in tiny pilot

NCT ID NCT06567925

Symptom relief Sponsor: Virginia Commonwealth University Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This pilot study tested whether sleep coaching and sleep hygiene training could help people with a common type of heart failure (HFpEF) sleep better and feel better. Ten participants wore activity trackers and kept sleep diaries to see if they could gradually extend their sleep time. The goal was to see if this approach is feasible and might improve quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Customized sleep coaching and sleep hygiene training
What this could lead to
If successful, this approach could point toward a non-drug way to improve sleep and quality of life in heart failure patients.
What could go wrong
This is a very small pilot study with only 10 participants, so results may not apply to everyone. The intervention is behavioral and effects may be modest.

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.

Participants

10 people

The number who actually took part.

Started

Jan 2025

Finished

May 2025

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 years and older

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: * confirmed clinical diagnosis of stable HF (NYHA class II-III) * left ventricular ejection fraction\>50% documented in the prior 12 months * aged ≥18 years * habitual reported sleep duration ≤7 hours * sleep efficiency \<85% measured during the 1-week run-in phase Exclusion Criteria: * concomitant conditions that can limit physical activity * severe debilitating diseases (ischemic heart disease. angina, arterial fibrillation, moderate to severe valvular disease) * taking sleep medicine or melatonin irregularly * pregnancy * stage V kidney disease (with dialysis) * shift worker * insomnia * hospitalization within the last 2 months * patients with sleep and circadian disorders * fluid overload * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners

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Conditions

The condition(s) this trial relates to.

diastolic heart failure

As listed by the trial registrant

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

Heart failure with preserved ejection fraction

Contacts and locations

Locations

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

More trials for these conditions

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