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Headphones vs. delirium: music therapy tested in ICU

NCT ID NCT07369258

Prevention Sponsor: HOSPITAL BRITANICO DE BUENOS AIRES Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether listening to music through headphones can prevent delirium in adults aged 65 and older in the intensive care unit. Participants will listen to either personalized or relaxing music twice daily for up to 7 days, while researchers track days free of delirium and coma. The goal is to see if music offers a simple, non-drug way to protect brain function during critical illness.

What this could mean

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

Active substance
music
What this could lead to
If it works, this could offer a simple, drug-free way to prevent delirium in older ICU patients, potentially reducing hospital stays and complications.
What could go wrong
This is an early-stage trial with 330 participants, so results may not apply to all ICU settings. The effect may be small or no different from standard care.

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 330 people

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

Started

Feb 2026

Expected to finish

Jan 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

65 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: * Age 65 years or older. * Negative Confusion Assessment Method for the ICU (CAM-ICU) at the time of randomization. * Expected ICU length of stay of at least 48 hours based on clinical judgement at admission (e.g., need for mechanical ventilation, vasopressors, invasive monitoring). Exclusion Criteria: * Positive CAM-ICU prior to randomization. * Acute primary Central Nervous System pathology (e.g., ischemic or hemorrhagic stroke, traumatic brain injury, meningoencephalitis, intracranial hypertension) presenting with altered sensorium (Glasgow Coma Scale at admission \< 14) or focal deficit preventing cognitive assessment (e.g., severe aphasia). * Severe chronic cognitive impairment or advanced dementia, defined by a known history of severe functional dependence prior to admission (requiring permanent assistance for basic activities of daily living such as feeding or grooming) * Unresolved auditory or visual impairment. * Suspected or confirmed intoxication with drugs or alcohol at admission. * Uncontrolled psychiatric disease (at least one acute episode requiring intervention in the last 6 months). * Richmond Agitation-Sedation Scale (RASS) score \< -2 or \> +2 at the time of randomization. * Medical condition precluding the safe use of headphones (e.g., burns, skull fracture, skin lesions). * Inability to establish effective communication due to a language disorder or unresolved language barrier. * Inability of the patient or legal representative to provide informed consent. * Patients with imminent death, end-of-life care, or limitation of therapeutic effort.

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Conditions

The condition(s) this trial relates to.

Critical Illness Psychomotor Agitation delirium prevention target

As listed by the trial registrant

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

Critical illness Delirium

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

  • Hospital Británico de Buenos Aires

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

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