NCT07369258 · RECRUITING
Clinical Application of Listening to Music to Prevent Delirium in the Intensive Care Unit
This trial is testing whether listening to music through headphones twice a day can help prevent delirium in older adults in the ICU. It compares personalized music playlists to generic relaxing music to standard ICU care, measuring how many days patients stay free of delirium and coma over one week. This is a Phase NA trial, meaning it is evaluating a practical care intervention rather than a drug, and no prior phase testing was required.
You may qualify if
- 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).
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-04