40 Hz Gamma Auditory Stimulation for Delirium Prevention in Critically Ill ICU Patients

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

  1. Minor Study First Submitted
Delirium is a common acute disturbance of attention and cognition among critically ill patients and is associated with prolonged mechanical ventilation, longer hospital stays, and increased mortality. This multicenter, quadruple-masked, randomized controlled trial will evaluate whether 40 Hz gamma auditory stimulation can help prevent delirium in mechanically ventilated adult ICU patients. A total of 142 participants aged 50 years or older who are expected to require mechanical ventilation for at least 48 hours will be randomly assigned in a 1:1 ratio to receive either 40 Hz gamma auditory stimulation or a silent audio track, in addition to standard ICU care. The assigned intervention will be delivered through identical earphones twice daily at 08:00 and 20:00, for 60 minutes per session, until extubation or Day 7 after randomization, whichever occurs first. The primary outcome is the number of delirium- and coma-free days during the first 7 days after randomization. Secondary outcomes include the incidence and duration of delirium during this period, duration of mechanical ventilation, length of ICU and hospital stay through Day 28, and 28-day all-cause mortality.
Trial Details
NCT Number NCT07875374
Lead Sponsor Peking Union Medical College Hospital
Conditions
(from sponsor)
Delirium
Related terms Delirium
Enrollment 142 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov