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Can a headset tune out caregiver stress? new trial aims to find out

NCT ID NCT05209438

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 pilot study tests whether a device called Cereset Research can help caregivers of people with dementia who feel stressed, anxious, or have trouble sleeping. The device plays tones that echo the brain's own rhythms, aiming to improve heart rate variability and reduce stress. Twenty caregivers will use the device over four weeks, and researchers will measure changes in blood pressure, heart rate, and self-reported stress and sleep quality.

What this could mean

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

Active substance
Cereset Research device (brainwave echo via audible tones)
What this could lead to
If it works, this could offer a drug-free way to help caregivers manage stress and improve heart health.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply widely. The device is experimental and not yet proven effective.

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

About 20 people

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

Started

Jun 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

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

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: * Participants must provide caregiving at least 10 hours per week. This includes all types of caregiving * participants must be willing to provide informed consent * participants must be able to comply with basic instructions * participants must be able to sit comfortably for up to 90 minutes, and attend up to three 60-minute intervention sessions each week during the 4-week intervention period * participants must self report experiencing symptoms of stress, anxiety, or insomnia and meet threshold scores on one or more self-report inventories of these symptoms (Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale) Exclusion criteria: * participants providing less than 10 hours a week of care to a person * participants who are unable or unwilling to attend intervention sessions during the planned study period * participants who are unable or unwilling to provide consent * participants who are not exhibiting symptoms of stress, anxiety or insomnia * participants with hearing impairment severe enough that they cannot perceive tones through ear buds * participants with known seizure disorder, or suicidal thoughts within the last 3 months * participants who respond positively to a question about risk for suicide within the last 3 months will be excluded and receive a behavioral health resource list * participants weighing more than 400 pounds (the weight limit of the chair used during intervention) * participants currently enrolled in another intervention study * prior use (past 3 years) of the technology being tested * prior use of neuromodulation, neurostimulation, deep brain stimulation, neurofeedback, biofeedback, alpha stim, Eye Movement Desensitization and Reprocessing (EMDR),or electroconvulsive therapy within the last month * Pace makers and beta blockers that affect the assessment of heart rate variability will also be exclusionary * participants taking Medications that may affect the assessment of heart rate variability (beta blockers.

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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

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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