DeliriumNCT07875374
40 Hz Gamma Auditory Stimulation for Delirium Prevention in Critically Ill ICU Patients
A study testing 40 Hz Gamma Auditory Stimulation in people with Delirium, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- 40 Hz Gamma Auditory Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expected duration of mechanical ventilation of at least 48 hours.
- Age 50 years or older, with no upper age limit.
Who cannot join
- Known moderate-to-severe neurocognitive or psychiatric disorders that would confound delirium assessment, such as dementia or schizophrenia.
- Severe or worse hearing impairment, defined as Grade 3 or higher according to the World Health Organization classification of hearing impairment.
- Previous treatment with antipsychotic medication.
- Epilepsy or a history of epilepsy.
- Moribund condition with an expected survival of no more than 24 hours.
- Inability to wear earphones because of head trauma or surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yuechuan Xue, MD, +86 18631096780, xueyuechuan@pumch.cn
About this study
Official title: Efficacy of 40 Hz Gamma Auditory Stimulation for the Prevention of Delirium in Critically Ill ICU Patients: A Multicenter Prospective Randomized Controlled Trial
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.
- Conditions
- Delirium
- Being tested
- 40 Hz Gamma Auditory Stimulation, Silent Audio Control
- Keywords
- ICU Delirium, 40 Hz Gamma Auditory Stimulation, Gamma Entrainment, Auditory Stimulation, Mechanical Ventilation
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 Hz Gamma Auditory StimulationDevice
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.
Silent Audio ControlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 40 Hz Gamma Auditory Stimulation Group | Experimental | 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. Receives: Device: 40 Hz Gamma Auditory Stimulation |
| Silent Audio Control Group | Sham comparator | 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. Receives: Device: Silent Audio Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization through Day 7.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization through Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Long, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875374
- Sponsor's protocol ID
- I-26PJ1504
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martorell AJ, Paulson AL, Suk HJ, Abdurrob F, Drummond GT, Guan W, Young JZ, Kim DN, Kritskiy O, Barker SJ, Mangena V, Prince SM, Brown EN, Chung K, Boyden ES, Singer AC, Tsai LH. Multi-sensory Gamma Stimulation Ameliorates Alzheimer's-Associated Pathology and Improves Cognition. Cell. 2019 Apr 4;177(2):256-271.e22. doi: 10.1016/j.cell.2019.02.014. Epub 2019 Mar 14.
PubMed 30879788Thom RP, Levy-Carrick NC, Bui M, Silbersweig D. Delirium. Am J Psychiatry. 2019 Oct 1;176(10):785-793. doi: 10.1176/appi.ajp.2018.18070893. No abstract available.
PubMed 31569986Mehta S, Cook D, Devlin JW, Skrobik Y, Meade M, Fergusson D, Herridge M, Steinberg M, Granton J, Ferguson N, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Mallick R, Reynolds S, Keenan S, Burry L; SLEAP Investigators; Canadian Critical Care Trials Group. Prevalence, risk factors, and outcomes of delirium in mechanically ventilated adults. Crit Care Med. 2015 Mar;43(3):557-66. doi: 10.1097/CCM.0000000000000727.
PubMed 25493968Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PubMed 15082703van den Boogaard M, Schoonhoven L, Evers AW, van der Hoeven JG, van Achterberg T, Pickkers P. Delirium in critically ill patients: impact on long-term health-related quality of life and cognitive functioning. Crit Care Med. 2012 Jan;40(1):112-8. doi: 10.1097/CCM.0b013e31822e9fc9.
PubMed 21926597Heffernan AB, Steinruecke M, Dempsey G, Chandran S, Selvaraj BT, Jiwaji Z, Stavrou M. Role of glia in delirium: proposed mechanisms and translational implications. Mol Psychiatry. 2025 Mar;30(3):1138-1147. doi: 10.1038/s41380-024-02801-4. Epub 2024 Oct 27.
PubMed 39463449Khan BA, Perkins AJ, Prasad NK, Shekhar A, Campbell NL, Gao S, Wang S, Khan SH, Marcantonio ER, Twigg HL 3rd, Boustani MA. Biomarkers of Delirium Duration and Delirium Severity in the ICU. Crit Care Med. 2020 Mar;48(3):353-361. doi: 10.1097/CCM.0000000000004139.
PubMed 31770149Ritter C, Tomasi CD, Dal-Pizzol F, Pinto BB, Dyson A, de Miranda AS, Comim CM, Soares M, Teixeira AL, Quevedo J, Singer M. Inflammation biomarkers and delirium in critically ill patients. Crit Care. 2014 May 23;18(3):R106. doi: 10.1186/cc13887.
PubMed 24886875Munster BC, Aronica E, Zwinderman AH, Eikelenboom P, Cunningham C, Rooij SE. Neuroinflammation in delirium: a postmortem case-control study. Rejuvenation Res. 2011 Dec;14(6):615-22. doi: 10.1089/rej.2011.1185. Epub 2011 Oct 6.
PubMed 21978081Fan YY, Luo RY, Wang MT, Yuan CY, Sun YY, Jing JY. Mechanisms underlying delirium in patients with critical illness. Front Aging Neurosci. 2024 Sep 26;16:1446523. doi: 10.3389/fnagi.2024.1446523. eCollection 2024.
PubMed 39391586Bloem B, Poorthuis RB, Mansvelder HD. Cholinergic modulation of the medial prefrontal cortex: the role of nicotinic receptors in attention and regulation of neuronal activity. Front Neural Circuits. 2014 Mar 11;8:17. doi: 10.3389/fncir.2014.00017. eCollection 2014.
PubMed 24653678Klinkenberg I, Sambeth A, Blokland A. Acetylcholine and attention. Behav Brain Res. 2011 Aug 10;221(2):430-42. doi: 10.1016/j.bbr.2010.11.033. Epub 2010 Nov 23.
PubMed 21108972Baldauf D, Desimone R. Neural mechanisms of object-based attention. Science. 2014 Apr 25;344(6182):424-7. doi: 10.1126/science.1247003. Epub 2014 Apr 10.
PubMed 24763592Sahu PP, Tseng P. Gamma sensory entrainment for cognitive improvement in neurodegenerative diseases: opportunities and challenges ahead. Front Integr Neurosci. 2023 Apr 17;17:1146687. doi: 10.3389/fnint.2023.1146687. eCollection 2023.
PubMed 37138796Murdock MH, Yang CY, Sun N, Pao PC, Blanco-Duque C, Kahn MC, Kim T, Lavoie NS, Victor MB, Islam MR, Galiana F, Leary N, Wang S, Bubnys A, Ma E, Akay LA, Sneve M, Qian Y, Lai C, McCarthy MM, Kopell N, Kellis M, Piatkevich KD, Boyden ES, Tsai LH. Multisensory gamma stimulation promotes glymphatic clearance of amyloid. Nature. 2024 Mar;627(8002):149-156. doi: 10.1038/s41586-024-07132-6. Epub 2024 Feb 28.
PubMed 38418876
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 40 Hz Gamma Auditory Stimulation for the Prevention of Delirium in Critically Ill ICU Patients: A Multicenter Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07875374
- Acronym / sponsor ID
- I-26PJ1504
- Conditions
- Delirium
- Keywords
- ICU Delirium, 40 Hz Gamma Auditory Stimulation, Gamma Entrainment, Auditory Stimulation, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 Hz Gamma Auditory Stimulation Group | Experimental | Device: 40 Hz Gamma Auditory StimulationParticipants 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 ControlParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Expected duration of mechanical ventilation of at least 48 hours.
- Age 50 years or older, with no upper age limit.
Key exclusion criteria (6 listed)
- Known moderate-to-severe neurocognitive or psychiatric disorders that would confound delirium assessment, such as dementia or schizophrenia.
- Severe or worse hearing impairment, defined as Grade 3 or higher according to the World Health Organization classification of hearing impairment.
- Previous treatment with antipsychotic medication.
- Epilepsy or a history of epilepsy.
- Moribund condition with an expected survival of no more than 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 Hz Gamma Auditory Stimulation40 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. | Device | 40 Hz Gamma Auditory Stimulation Group |
| Silent Audio ControlA 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. | Device | Silent Audio Control Group |
Primary outcome
Delirium- and Coma-Free Days During the First 7 Days After Randomization
Time frame: From randomization through Day 7.
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.
6 secondary outcomes
Incidence of Delirium During the First 7 Days After Randomization
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
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
Time frame: From randomization through Day 28.
Length of ICU Stay
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
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
Time frame: From randomization through Day 28.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 30879788Martorell AJ, Paulson AL, Suk HJ, Abdurrob F, Drummond GT, Guan W, Young JZ, Kim DN, Kritskiy O, Barker SJ, Mangena V, Prince SM, Brown EN, Chung K, Boyden ES, Singer AC, Tsai LH. Multi-sensory Gamma Stimulation Ameliorates Alzheimer's-Associated Pathology and Improves Cognition. Cell. 2019 Apr 4;177(2):256-271.e22. doi: 10.1016/j.cell.2019.02.014. Epub 2019 Mar 14.
- Background: PubMed 31569986Thom RP, Levy-Carrick NC, Bui M, Silbersweig D. Delirium. Am J Psychiatry. 2019 Oct 1;176(10):785-793. doi: 10.1176/appi.ajp.2018.18070893. No abstract available.
- Background: PubMed 25493968Mehta S, Cook D, Devlin JW, Skrobik Y, Meade M, Fergusson D, Herridge M, Steinberg M, Granton J, Ferguson N, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Mallick R, Reynolds S, Keenan S, Burry L; SLEAP Investigators; Canadian Critical Care Trials Group. Prevalence, risk factors, and outcomes of delirium in mechanically ventilated adults. Crit Care Med. 2015 Mar;43(3):557-66. doi: 10.1097/CCM.0000000000000727.
- Background: PubMed 15082703Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Background: PubMed 21926597van den Boogaard M, Schoonhoven L, Evers AW, van der Hoeven JG, van Achterberg T, Pickkers P. Delirium in critically ill patients: impact on long-term health-related quality of life and cognitive functioning. Crit Care Med. 2012 Jan;40(1):112-8. doi: 10.1097/CCM.0b013e31822e9fc9.
- Background: PubMed 39463449Heffernan AB, Steinruecke M, Dempsey G, Chandran S, Selvaraj BT, Jiwaji Z, Stavrou M. Role of glia in delirium: proposed mechanisms and translational implications. Mol Psychiatry. 2025 Mar;30(3):1138-1147. doi: 10.1038/s41380-024-02801-4. Epub 2024 Oct 27.
- Background: PubMed 31770149Khan BA, Perkins AJ, Prasad NK, Shekhar A, Campbell NL, Gao S, Wang S, Khan SH, Marcantonio ER, Twigg HL 3rd, Boustani MA. Biomarkers of Delirium Duration and Delirium Severity in the ICU. Crit Care Med. 2020 Mar;48(3):353-361. doi: 10.1097/CCM.0000000000004139.
- Background: PubMed 24886875Ritter C, Tomasi CD, Dal-Pizzol F, Pinto BB, Dyson A, de Miranda AS, Comim CM, Soares M, Teixeira AL, Quevedo J, Singer M. Inflammation biomarkers and delirium in critically ill patients. Crit Care. 2014 May 23;18(3):R106. doi: 10.1186/cc13887.
- Background: PubMed 21978081Munster BC, Aronica E, Zwinderman AH, Eikelenboom P, Cunningham C, Rooij SE. Neuroinflammation in delirium: a postmortem case-control study. Rejuvenation Res. 2011 Dec;14(6):615-22. doi: 10.1089/rej.2011.1185. Epub 2011 Oct 6.
- Background: PubMed 39391586Fan YY, Luo RY, Wang MT, Yuan CY, Sun YY, Jing JY. Mechanisms underlying delirium in patients with critical illness. Front Aging Neurosci. 2024 Sep 26;16:1446523. doi: 10.3389/fnagi.2024.1446523. eCollection 2024.
- Background: PubMed 24653678Bloem B, Poorthuis RB, Mansvelder HD. Cholinergic modulation of the medial prefrontal cortex: the role of nicotinic receptors in attention and regulation of neuronal activity. Front Neural Circuits. 2014 Mar 11;8:17. doi: 10.3389/fncir.2014.00017. eCollection 2014.
- Background: PubMed 21108972Klinkenberg I, Sambeth A, Blokland A. Acetylcholine and attention. Behav Brain Res. 2011 Aug 10;221(2):430-42. doi: 10.1016/j.bbr.2010.11.033. Epub 2010 Nov 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yun Long, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40 Hz Gamma Auditory Stimulation in people with Delirium, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuechuan Xue, MD (+86 18631096780, xueyuechuan@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium- and Coma-Free Days During the First 7 Days After Randomization (time frame: From randomization through Day 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07875374, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.