NCT07369258 Clinical Application of Listening to Music to Prevent Delirium in the Intensive Care Unit
| NCT ID | NCT07369258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HOSPITAL BRITANICO DE BUENOS AIRES |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 330 participants in total. It began in 2026-02-02 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if listening to music can prevent delirium in older adults admitted to the Intensive Care Unit (ICU). The main questions it aims to answer are: * Does listening to music increase the number of days participants are alive and free of delirium and coma during a 7-day period? * Is personalized music more effective than generic relaxing music? Researchers will compare Personalized Music and Relaxing Music to Standard Care (no study-provided music) to see if the music intervention improves delirium outcomes compared to usual care. Participants will: * Listen to music through headphones twice daily (morning and afternoon) for at least 30 minutes during a 7-day period (intervention groups). * Receive standard ICU care and undergo daily assessments for delirium and level of consciousness.
Eligibility 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.
Contact & Investigator
Sebastián Consalvo, MD
PRINCIPAL INVESTIGATOR
Hospital Británico de Buenos Aires
Frequently Asked Questions
Who can join the NCT07369258 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07369258 currently recruiting?
Yes, NCT07369258 is actively recruiting participants. Contact the research team at sebasconsalvo@gmail.com for enrollment information.
Where is the NCT07369258 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina.
Who is sponsoring the NCT07369258 clinical trial?
NCT07369258 is sponsored by HOSPITAL BRITANICO DE BUENOS AIRES. The principal investigator is Sebastián Consalvo, MD at Hospital Británico de Buenos Aires. The trial plans to enroll 330 participants.