An interventional study of Acoustic Stimulation in Alzheimer s Disease, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Basic science
This summary focuses on the acoustic stimulation part of the study.
The goal of this interventional study is to learn if acoustic stimulation during sleep works to improve cognitive function in patients with Alzheimer's disease. It will also learn about safety and feasibility. The main questions are:
Does acoustic stimulation during NREM sleep improve cognitive function in patients with mild cognitive impairment due to Alzheimer's disease (AD-MCI)? How does acoustic stimulation compare with sham stimulation?
Researchers will compare acoustic stimulation with sham stimulation. Participants will:
Be assigned to the acoustic stimulation group (n=20) or the sham stimulation group (n=20).
Receive a familiar, comfortable sound at the bedside during stable NREM sleep, or sham stimulation, with 30 seconds of stimulation every 1 minute, triggered upon entering NREM sleep, with no limit on the number of stimulations.
Complete cognitive assessments and sleep EEG monitoring before and after the intervention.
Be monitored for safety throughout the study. The study is sponsored by Xuanwu Hospital, Capital Medical University. It is funded by the National Natural Science Foundation of China Key International Cooperation Project (Grant No. 82220108009). The study period runs from ethics approval to December 2024. No other centers are participating. Participants will be 60-75 years old and recruited from the neurology wards of Xuanwu Hospital.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- (1) Meets the diagnostic criteria for mild cognitive impairment (according to Petersen criteria): ① insidious onset; ② memory impairment is the primary complaint; ③ objective evidence of memory decline (defined quantitatively as a decline of more than 1.5 standard deviations below age- and education-matched controls); ④ may be accompanied by other cognitive impairments, but memory decline is more prominent; ⑤ general cognitive function is normal; ⑥ preservation of activities of daily living, with an Activities of Daily Living (ADL) scale score \<23; ⑦ does not meet the diagnostic criteria for dementia; ⑧ imaging findings support the diagnosis.
(2) Amyloid PET positivity or reduced cerebrospinal fluid amyloid levels. (3) The patient should have a stable and reliable caregiver, or at least be able to maintain frequent contact with a caregiver. The caregiver must be able to accompany and assist the patient throughout the entire study, must accompany the subject to study visits, and must have sufficient interaction and communication with the subject to provide valuable information for the scoring of various scales.
Exclusion Criteria:
(1) Presence of memory and cognitive decline caused by other non-AD conditions, such as other types of dementia, including but not limited to mixed dementia (AD-VaD), vascular dementia (VD), Parkinson's disease dementia (PDD), dementia with Lewy bodies (DLB), Huntington's disease-related dementia, and frontotemporal dementia (FTD); endocrine disorders (e.g., thyroid disease, parathyroid disease); folate or vitamin B12 deficiency; or dementia caused by any other reason.
(2) At screening, MRI shows significant focal lesions: more than 2 infarcts with a diameter greater than 2 cm, or infarcts in key regions such as the thalamus, hippocampus, entorhinal cortex, perirhinal cortex, angular gyrus, and other cortical and subcortical gray matter nuclei.
(3) Presence of moderate to severe white matter degeneration (Fazekas score 3-6).
(4) Presence of metallic foreign bodies or other implanted electronic devices, or claustrophobia, etc., which preclude TMS treatment or MRI scanning.
(5) Severe visual, auditory, motor, or consciousness impairment that prevents cooperation with examinations and treatment.
(6) History of seizures (presence of at least 2 unprovoked seizures occurring more than 24 hours apart, or diagnosis of an epilepsy syndrome, or a seizure within the past 12 months).
(7) Acute cardiovascular or cerebrovascular events (e.g., unstable angina, severe arrhythmia, myocardial infarction, , or ischemic stroke) within 3 months before screening.
(8) Severe systemic diseases involving the heart, lungs, liver, kidneys, etc., identified by laboratory tests or examinations, and not controlled by conventional medication.
(9) Patients with concurrent malignant tumors; or patients with a of less than 1 year due to causes other than AD.
(10) History of alcohol or drug abuse. (11) Received other TMS treatment within 3 months. (12) Participated in or is currently participating in another clinical trial within 3 months.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A familiar, comfortable sound will be provided at the patient's bedside. Stimulation will be delivered during stable NREM sleep: each stimulation lasts 30 seconds, with a 1-minute interval between stimulations. Stimulation is triggered upon entry into NREM sleep, and the number of stimulations is unlimited.
Other: Acoustic Stimulation
A familiar, comfortable sound that was not presented during the encoding phase will be provided at the patient's bedside. Stimulation will be delivered during stable NREM sleep: each stimulation lasts 30 seconds, with a 1-minute interval between stimulations. Stimulation is triggered upon entry into NREM sleep, and the number of stimulations is unlimited. This serves as an active comparator to control for the non-specific effects of acoustic stimulation during sleep.
Other: Acoustic Stimulation
Acoustic stimulation will be delivered at the patient's bedside during stable NREM sleep. The system uses a closed-loop design: a familiar, comfortable sound is triggered upon entry into NREM sleep, each stimulation lasts 30 seconds, with a 1-minute interval, and the number of stimulations is unlimited. In the experimental arm, the sounds are paired with a prior memory encoding task. In the active comparator arm, the sounds are unpaired (not presented during the encoding task), but all other acoustic parameters and NREM-triggered delivery remain identical. This distinguishes the intervention from standard acoustic stimulation or non-closed-loop auditory stimulation used in other studies.
Computerized 1 × 5 Random Sequence Learning Task Accuracy
Cognitive performance will be assessed using a computerized 1 × 5 random sequence learning task at three time points: before sleep (baseline), the morning after sleep, and one week after the initial assessment. Changes in task performance across these three assessments will be evaluated.
Time frame: Before sleep (baseline), the morning after sleep, and 1 week after the initial assessment.
Computerized 1 × 5 Random Sequence Learning Task Reaction Time
Cognitive performance will be assessed using a computerized 1 × 5 random sequence learning task at three time points: before sleep (baseline), the morning after sleep, and one week after the initial assessment. Changes in task performance across these three assessments will be evaluated.
Time frame: Before sleep (baseline), the morning after sleep, and 1 week after the initial assessment.
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Nov 2026, 18 months after the start.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 18 months is below that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.