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Sound waves for better sleep: new trial tests ultrasound on heart patients

NCT ID NCT07595068

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 1 time

Summary

This study tests whether low-intensity focused ultrasound (LIFU) applied to a nerve cluster in the neck can improve sleep quality and heart rate control in people recovering from heart surgery. 200 participants will receive either real or sham ultrasound daily for 3-7 days after their procedure. Researchers will monitor heart rate variability, sleep patterns, and stress markers to see if this non-invasive approach helps the body recover better.

What this could mean

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

Active substance
low-intensity focused ultrasound (LIFU) device
What this could lead to
If it works, this could offer a non-drug way to improve sleep and heart rate regulation after heart surgery, potentially reducing complications.
What could go wrong
This is an early-stage trial with only 200 participants, so results may not apply to everyone. The effect may be small or no better than placebo.

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 200 people

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

Started

May 2026

Expected to finish

Apr 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 to 79 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: 1. Diagnosed with cardiovascular disease (CVD) and scheduled to undergo cardiology-related surgical treatment 2. Able to receive and tolerate the aforementioned cardiology-related surgical treatment 3. Aged between 18 and 79 years (inclusive), with no restriction on gender 4. Agree to accept random allocation of the treatment strategies 5. With clear consciousness, no severe mental disorders or cognitive impairment; voluntarily sign the written informed consent form (ICF) and are willing to actively cooperate with the study treatment Exclusion Criteria: 1. Have used sedative-hypnotic drugs, antipsychotic drugs, opioid analgesics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), central nervous system (CNS) stimulant drugs, or any other medications that alter sleep architecture within the past 30 days 2. Have a history of cervical infection, trauma, severe cervical deformity, or prior cervical surgery 3. Unable to complete the daily study intervention as required by the trial protocol 4. Are participating in another clinical trial, or have participated in other clinical trials with interventions that may interfere with the results of this study 5. Have undergone major surgery or general anesthesia within the past 30 days 6. Have a history of alcohol abuse 7. Are female subjects who are pregnant or lactating, or plan to become pregnant during the study period 8. Have severe cognitive impairment, severe psychiatric disorders, epilepsy, or other related neurological disorders 9. Have concomitant malignant tumor or severe dysfunction of vital organs 10. Have active systemic infection 11. Have significant bleeding tendency, or renal failure undergoing regular hemodialysis 12. Are deemed unsuitable for the trial by the investigator for any other reason -

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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

    7 sites. 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

  • Huangshi Central Hospital

    NOT_YET_RECRUITING

    Huangshi, Hubei, 430060, China

  • Jingzhou Central Hospital

    NOT_YET_RECRUITING

    Jingzhou, Hubei, 430060, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Wuhan Central Hospital

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430060, China

  • Wuhan Third Hospital

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430060, China

  • Xiangyang Central Hospital

    NOT_YET_RECRUITING

    Xiangyang, Hubei, 430060, China

  • Yichang Central People's Hospital

    NOT_YET_RECRUITING

    Yichang, Hubei, 430060, China

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