Listening to music to prevent delirium in older adults in the ICU
Music to Prevent Delirium: A Prospective, Randomized, Controlled, Three-Arm Parallel-Group Clinical Trial in an Argentine Intensive Care Unit
This trial will try whether personalized or relaxing music, played twice daily for a week, can prevent delirium and increase days alive and free of delirium or coma in adults 65 and older in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Hospital Britanico de Buenos Aires Academic / other |
| Locations | 1 site (Buenos Aires, Buenos Aires F.D.) |
| Trial ID | NCT07369258 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are ICU patients aged 65 or older who are CAM-ICU negative with a RASS between -2 and +2, expected to remain in the ICU at least 48 hours, and without severe preexisting cognitive or acute CNS conditions.
Not a fit: Patients with active delirium before randomization, severe dementia or functional dependence, unresolved hearing loss, acute primary CNS pathology, or intoxication are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could increase delirium-free days in older ICU patients, potentially reducing complications and longer-term cognitive problems.
How similar studies have performed: Prior small trials and observational studies suggest music can reduce anxiety and agitation in hospitalized patients, but randomized evidence specifically showing prevention of ICU delirium with music is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Buenos Aires, Buenos Aires F.D.
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.