Alzheimer s DiseaseNCT07924657
Acoustic Stimulation During Sleep for Alzheimer's Disease
A study testing Acoustic Stimulation in people with Alzheimer s Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Alzheimer s Disease
- What is being tested?
- Acoustic Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 30 Dec 2026
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
- 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.
Who cannot join
- (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.
- 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.
- Presence of moderate to severe white matter degeneration (Fazekas score 3-6).
- Presence of metallic foreign bodies or other implanted electronic devices, or claustrophobia, etc., which preclude TMS treatment or MRI scanning.
- Severe visual, auditory, motor, or consciousness impairment that prevents cooperation with examinations and treatment.
- 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).
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- Acute cardiovascular or cerebrovascular events (e.g., unstable angina, severe arrhythmia, myocardial infarction, transient ischemic attack, or ischemic stroke) within 3 months before screening.
- Severe systemic diseases involving the heart, lungs, liver, kidneys, etc., identified by laboratory tests or examinations, and not controlled by conventional medication.
- Patients with concurrent malignant tumors; or patients with a life expectancy of less than 1 year due to causes other than AD.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sleep-Stage Acoustic Stimulation for Cognitive Improvement in Alzheimer's Disease: A Randomized Sham-Controlled Study
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:
Read more
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.
- Conditions
- Alzheimer s Disease
- Being tested
- Acoustic Stimulation
- Keywords
- alzheimer, Acoustic Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic StimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acoustic Stimulation group | Experimental | 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. Receives: Other: Acoustic Stimulation |
| Active comparator | Active comparator | 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. Receives: Other: Acoustic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before sleep (baseline), the morning after sleep, and 1 week after the initial assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start1 May 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924657
- Sponsor's protocol ID
- 2024390
- Other IDs
- 82220108009
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep-Stage Acoustic Stimulation for Cognitive Improvement in Alzheimer's Disease: A Randomized Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT07924657
- Acronym / sponsor ID
- 2024390
- Conditions
- Alzheimer s Disease
- Keywords
- alzheimer, Acoustic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Nov 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acoustic Stimulation group | Experimental | Other: Acoustic StimulationA 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. |
| Active comparator | Active comparator | Other: Acoustic StimulationA 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (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.
- 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.
Key exclusion criteria (10 listed)
- (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.
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 |
|---|---|---|
| Acoustic StimulationAcoustic 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. | Other | Acoustic Stimulation group, Active comparator |
Primary outcome
Computerized 1 × 5 Random Sequence Learning Task Accuracy
Time frame: Before sleep (baseline), the morning after sleep, and 1 week after the initial assessment.
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.
Computerized 1 × 5 Random Sequence Learning Task Reaction Time
Time frame: Before sleep (baseline), the morning after sleep, and 1 week after the initial assessment.
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.
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 9 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic Stimulation in people with Alzheimer s Disease, run by Xuanwu Hospital, Beijing 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 10 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: looking for participants now, as of the sponsor's last update on 9 Nov 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. 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 Tao Wei, MD (15650228107, twei2019@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized 1 × 5 Random Sequence Learning Task Accuracy (time frame: Before sleep (baseline), the morning after sleep, and 1 week after the initial assessment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2026.