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Soothing sounds may shield seniors from ICU brain fog

NCT ID NCT04182334

Symptom relief Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether listening to slow-tempo music through noise-cancelling headphones twice a day could help older adults in the ICU avoid delirium—a state of confusion linked to longer hospital stays and lasting cognitive problems. Researchers enrolled 160 critically ill patients aged 50 and older who were on breathing machines. For up to seven days, one group listened to slow music while a control group wore the same headphones without music. The goal was to see if music increased days free of delirium and coma.

What this could mean

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

Active substance
slow-tempo music listening sessions
What this could lead to
If it works, this could offer a simple, drug-free way to reduce delirium and improve recovery for older ICU patients.
What could go wrong
This is a small, completed study without a phase designation, so results may not be definitive or widely applicable. The benefit may be modest or not reproducible in larger, more diverse groups.

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

160 people

The number who actually took part.

Started

Mar 2020

Finished

Apr 2024

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

50 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: 1. Age 50 years or older. 2. English speaking. 3. Admitted to the intensive care unit (medical or surgical). 4. Expected mechanical ventilator support for ≥48 hours. 5. Consentable through a legally authorized representative. 6. Have access to a telephone. Exclusion Criteria: 1. History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia. 2. Psychiatric illness which is not well controlled. 3. Alcohol withdrawal symptoms/concern for withdrawal. 4. Suspected or confirmed drug intoxication/overdose 5. Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery. 6. Uncorrected hearing or vision impairment including legal blindness. 7. Incarcerated at the time of study enrollment. 8. Enrolled in another clinical trial which does not permit co-enrollment. 9. Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder delirium Pain

As listed by the trial registrant

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

Anxiety Intensive care acquired cognitive impairment Intensive care unit delirium Pain

Contacts and locations

Locations

  • Eskenazi Hospital

    Indianapolis, Indiana, 46202, United States

  • IU Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • IU Health West Hospital

    Avon, Indiana, 46123, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Methodist Hospital

    Indianapolis, Indiana, 46202, United States

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