Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07369258
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07369258
Study Brief:
Protocol Section:
NCT07369258