Listening to music to prevent delirium in older adults in the ICU

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized controlled trial at Hospital Británico de Buenos Aires compares personalized music, relaxing (generic) music, and standard care in older critically ill patients. Eligible patients (age ≥65) who are CAM-ICU negative and within a defined window after achieving an adequate level of consciousness are randomized to one of three arms. Participants in the two music arms listen through headphones for at least 30 minutes twice daily over a 7-day period while all participants receive daily delirium and consciousness assessments. The primary outcome is days alive and free of delirium and coma during a 7-day observation period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Británico de Buenos Aires
  Buenos Aires, Buenos Aires F.D., Argentina Recruiting

Study contacts

• Principal investigator: Sebastián Consalvo, MD — Hospital Británico de Buenos Aires
• Study coordinator: Sebastián Consalvo, MD
• Email: sebasconsalvo@gmail.com
• Phone: +54 9 11 6784 9495

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.