An interventional study of 40 Hz Gamma Auditory Stimulation and Silent Audio Control in Delirium, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Prevention
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.
1,071 studies on the registry are indexed under Delirium; 239 are open to participants now.
This study's planned enrollment of 142 is above the median of 119 across 608 interventional studies indexed under Delirium.
Browse Delirium studies →Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
Device: 40 Hz Gamma Auditory Stimulation
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.
Device: Silent Audio Control
40 Hz isochronic tones are presented synchronously to both ears through standardized high-fidelity wired in-ear noise-canceling earphones. The sound level is maintained at 65-70 decibels (dB). The intervention is administered twice daily at 08:00 and 20:00 for 60 minutes per session, beginning after randomization and continuing until extubation or Day 7 after randomization, whichever occurs first. Standard ICU care is provided concurrently.
A silent audio track is presented through standardized high-fidelity wired in-ear noise-canceling earphones. The device appearance, wearing procedure, session schedule, and duration are matched to the experimental intervention. Sessions are administered twice daily at 08:00 and 20:00 for 60 minutes per session, beginning after randomization and continuing until extubation or Day 7 after randomization, whichever occurs first. Standard ICU care is provided concurrently.
Delirium- and Coma-Free Days During the First 7 Days After Randomization
Delirium- and coma-free days (DCFDs) are the total number of days during the first 7 days after randomization on which the participant is alive, not comatose (best daily Richmond Agitation-Sedation Scale \[RASS\] score of -3 or higher), and free of delirium (all Confusion Assessment Method for the ICU \[CAM-ICU\] assessments negative). A day with coma (best daily RASS score of -4 or -5) or any positive CAM-ICU assessment is scored as 0. Under the prespecified assignment rule, participants who die within 28 days after randomization are assigned a DCFD value of 0. Scores range from 0 to 7, with higher scores indicating a better outcome.
Time frame: From randomization through Day 7.
Incidence of Delirium During the First 7 Days After Randomization
The proportion of participants with at least one positive Confusion Assessment Method for the ICU (CAM-ICU) assessment during the observation period. CAM-ICU is performed when the Richmond Agitation-Sedation Scale (RASS) score is -3 or higher. A lower proportion indicates a better outcome.
Time frame: From the date of randomization until the date of ICU discharge or death, whichever occurs first, assessed up to 7 days after randomization.
Duration of Delirium During the First 7 Days After Randomization
The number of calendar days during the observation period on which the participant has at least one positive Confusion Assessment Method for the ICU (CAM-ICU) assessment. CAM-ICU is performed when the Richmond Agitation-Sedation Scale (RASS) score is -3 or higher. Values range from 0 to 7 days, with fewer days indicating a better outcome.
Time frame: From the date of randomization until the date of ICU discharge or death, whichever occurs first, assessed up to 7 days after randomization.
Duration of Mechanical Ventilation
The cumulative number of hours during which the participant is alive and receiving invasive mechanical ventilation after randomization. A shorter duration indicates a better outcome.
Time frame: From randomization through Day 28.
Length of ICU Stay
The total number of hours from randomization to ICU discharge, ICU death, or Day 28, whichever occurs first. A shorter duration indicates a better outcome.
Time frame: From the date of randomization until the date of ICU discharge or death in the ICU, whichever occurs first, assessed up to 28 days after randomization.
Total Length of Hospital Stay
The total number of days from randomization to hospital discharge, in-hospital death, or Day 28, whichever occurs first. A shorter duration indicates a better outcome.
Time frame: From the date of randomization until the date of hospital discharge or in-hospital death, whichever occurs first, assessed up to 28 days after randomization.
28-Day All-Cause Mortality
The proportion of participants who die from any cause within 28 days after randomization.
Time frame: From randomization through Day 28.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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