Efficacy of 40 Hz Gamma Auditory Stimulation for the Prevention of Delirium in Critically Ill ICU Patients: A Multicenter Prospective Randomized Controlled Trial
| Registry | NCT07875374 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 142 (Estimated) |
| Sponsor | Peking Union Medical College Hospital (Other) |
| Conditions | Delirium |
| Interventions | 40 Hz Gamma Auditory Stimulation, Silent Audio Control (Device) |
| Dates | start 2026-10-31 (estimated), primary completion 2028-11-30 (estimated), completion 2029-01-31 (estimated), first posted 2026-10-15, last updated 2026-10-15 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Delirium All trials of 40 Hz Gamma Auditory Stimulation All trials of Silent Audio Control
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 40 Hz Gamma Auditory Stimulation Group | Experimental | Device: 40 Hz Gamma Auditory Stimulation | Participants receive 40 Hz isochronic tones presented synchronously to both ears through standardized high-fidelity wired in-ear noise-canceling earphones, in addition to standard ICU care. The auditory stimulus is delivered at 65-70 decibels (dB) twice daily at 08:00 and 20:00 for 60 minutes per session. The intervention continues until extubation or Day 7 after randomization, whichever occurs first. |
| Silent Audio Control Group | Sham comparator | Device: Silent Audio Control | Participants receive a silent audio track through standardized high-fidelity wired in-ear noise-canceling earphones, in addition to standard ICU care. The device, wearing procedure, session schedule, and duration are matched to the experimental group. Sessions are administered twice daily at 08:00 and 20:00 for 60 minutes per session until extubation or Day 7 after randomization, whichever occurs first. |
Sex: All, ages: 50 Years to any
Inclusion Criteria: 1. Expected duration of mechanical ventilation of at least 48 hours. 2. Age 50 years or older, with no upper age limit. Exclusion Criteria: 1. Known moderate-to-severe neurocognitive or psychiatric disorders that would confound delirium assessment, such as dementia or schizophrenia. 2. Severe or worse hearing impairment, defined as Grade 3 or higher according to the World Health Organization classification of hearing impairment. 3. Previous treatment with antipsychotic medication. 4. Epilepsy or a history of epilepsy. 5. Moribund condition with an expected survival of no more than 24 hours. 6. Inability to wear earphones because of head trauma or surgery.
| Facility | City | Country | Status |
|---|---|---|---|
| Peking Union Medical College Hospital | Beijing, Beijing Municipality | China |