Mild Cognitive ImpairmentBB-MCINCT07735910
Binaural Beats for Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes
A study testing Binaural Beats Embedded in Old Songs and Old Songs in people with Mild Cognitive Impairment and Cognitive Function, run by China Medical University, China at 3 sites in China.
Trial summary
This study will evaluate whether binaural beats can improve cognitive function in older adults with mild cognitive impairment living in nursing homes. Participants will listen to 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Cognitive Function
- What is being tested?
- Binaural Beats Embedded in Old Songs and Old Songs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesChina
- Study dates
- 15 Jun 2026to 20 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years or older.
- Not previously diagnosed with dementia.
- Meets the diagnostic criteria for mild cognitive impairment, with Montreal Cognitive Assessment scores adjusted by education level, Mini-Mental State Examination score >= 24, and Activities of Daily Living score < 23.
- Has lived in a nursing home for more than 2 months and plans to continue living there during the study period.
- No hearing impairment; Hearing Handicap Inventory for the Elderly-Screening Version score < 8, and able to hear binaural beats through both ears.
- Conscious and able to cooperate with questionnaires and scale assessments.
- Has not taken medications that may affect cognitive function within 3 to 6 months before the intervention.
Who cannot join
- Severe physical disease, major organ failure, or advanced malignant tumor.
- Diagnosed depression or other psychiatric disorders.
- Withdrawal Criteria:
- Serious adverse events during the study, such as falls, disease recurrence, discomfort caused by the intervention audio, death, or other conditions making continued participation unsuitable.
- Voluntary withdrawal from the study.
- Removal Criteria:
Show all 9Show fewer
- Incomplete data resulting in missing information.
- Missing three or more intervention sessions within 2 weeks without following intervention instructions.
- Receiving other treatments or interventions related to cognitive function during the trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Jintaiyang Jingguan Elderly Care Apartment
Shenyang, Liaoning, 110030
Yuhan Geng, 18018945883, gengyuhan@cmu.edu.cn
- Recruiting
Jintaiyang Elderly Care Center, Huanggu Branch
Shenyang, Liaoning, 110031
Yuhan Geng, 18018945883, gengyuhan@cmu.edu.cn
- Recruiting
Renai Changwan Elderly Care Home, Dadong District
Shenyang, Liaoning, 110042
Yuhan Geng, 18018945883, gengyuhan@cmu.edu.cn
About this study
Official title: The Effect of Binaural Beats on Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes: A Randomized Controlled Trial
This study will evaluate whether binaural beats can improve cognitive function in older adults with mild cognitive impairment living in nursing homes. Participants will listen to 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. Cognitive function, sleep quality, anxiety, and depressive symptoms will be assessed before the intervention, after the intervention, and at a 2-week follow-up after the intervention. The study aims to determine whether binaural beats are a safe, simple, and non-drug approach to support cognitive health in older adults with mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment, Cognitive Function
- Being tested
- Binaural Beats Embedded in Old Songs, Old Songs
- Keywords
- Binaural Beats, Older Adults, Nursing Homes, Cognitive Function, Sleep Quality, Anxiety, Depression, Non-drug Intervention
- Medical subject headings
- Cognitive Dysfunction, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural Beats Embedded in Old SongsBehavioural
Participants in the intervention group will listen to old songs embedded with 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. The old songs will be selected according to older adults' music preferences.
Old SongsBehavioural
Participants in the control group will listen to old songs without binaural beats through headphones once daily for 30 minutes for 14 consecutive days. The old songs will be selected according to older adults' music preferences.
| Study group | Role | What they receive |
|---|---|---|
| Binaural Beats Plus Old Songs Group | Experimental | Participants will listen to old songs embedded with 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. Receives: Behavioral: Binaural Beats Embedded in Old Songs |
| Old Songs Group | Active comparator | Participants will listen to the same type of old songs without binaural beats through headphones once daily for 30 minutes for 14 consecutive days. Receives: Behavioral: Old Songs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment Score
Cognitive function will be assessed using the Montreal Cognitive Assessment. The total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Digit Span Test Score
Measured: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Stroop Color-Word Test Score
Measured: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Trail Making Test Score
Measured: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Pittsburgh Sleep Quality Index Score
Measured: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Geriatric Anxiety Scale Score
Measured: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Geriatric Depression Scale-15 Score
Measured: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start15 Jun 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to an intervention group or a control group to evaluate the effect of binaural beats on cognitive function.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuhan Geng, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735910
- Sponsor's protocol ID
- Lunshen [2025] 239
- Acronym
- BB-MCI
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Binaural Beats on Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07735910
- Acronym / sponsor ID
- BB-MCI / Lunshen [2025] 239
- Conditions
- Mild Cognitive Impairment, Cognitive Function
- Keywords
- Binaural Beats, Older Adults, Nursing Homes, Cognitive Function, Sleep Quality, Anxiety, Depression, Non-drug Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 30 Jul 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 study will evaluate whether binaural beats can improve cognitive function in older adults with mild cognitive impairment living in nursing homes. Participants will listen to 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. Cognitive function, sleep quality, anxiety, and depressive symptoms will be assessed before the intervention, after the intervention, and at a 2-week follow-up after the intervention. The study aims to determine whether binaural beats are a safe, simple, and non-drug approach to support cognitive health in older adults with mild cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to an intervention group or a control group to evaluate the effect of binaural beats on cognitive function.
| Arm | Type | Receives |
|---|---|---|
| Binaural Beats Plus Old Songs Group | Experimental | Behavioral: Binaural Beats Embedded in Old SongsParticipants will listen to old songs embedded with 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. |
| Old Songs Group | Active comparator | Behavioral: Old SongsParticipants will listen to the same type of old songs without binaural beats through headphones once daily for 30 minutes for 14 consecutive days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 60 years or older.
- Not previously diagnosed with dementia.
- Meets the diagnostic criteria for mild cognitive impairment, with Montreal Cognitive Assessment scores adjusted by education level, Mini-Mental State Examination score >= 24, and Activities of Daily Living score < 23.
- Has lived in a nursing home for more than 2 months and plans to continue living there during the study period.
- No hearing impairment; Hearing Handicap Inventory for the Elderly-Screening Version score < 8, and able to hear binaural beats through both ears.
Key exclusion criteria (9 listed)
- Severe physical disease, major organ failure, or advanced malignant tumor.
- Diagnosed depression or other psychiatric disorders.
- Serious adverse events during the study, such as falls, disease recurrence, discomfort caused by the intervention audio, death, or other conditions making continued participation unsuitable.
- Voluntary withdrawal from the study.
- Incomplete data resulting in missing information.
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 |
|---|---|---|
| Binaural Beats Embedded in Old SongsParticipants in the intervention group will listen to old songs embedded with 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. The old songs will be selected according to older adults' music preferences. | Behavioural | Binaural Beats Plus Old Songs Group |
| Old SongsParticipants in the control group will listen to old songs without binaural beats through headphones once daily for 30 minutes for 14 consecutive days. The old songs will be selected according to older adults' music preferences. | Behavioural | Old Songs Group |
Primary outcome
Change in Montreal Cognitive Assessment Score
Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Cognitive function will be assessed using the Montreal Cognitive Assessment. The total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Change in Digit Span Test Score
Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Stroop Color-Word Test Score
Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Trail Making Test Score
Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Pittsburgh Sleep Quality Index Score
Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Geriatric Anxiety Scale Score
Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Geriatric Depression Scale-15 Score
Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
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 30 Jul 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural Beats Embedded in Old Songs and Old Songs in people with Mild Cognitive Impairment and Cognitive Function, run by China Medical University, China at 3 sites 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 7 inclusion and 9 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Liu Yu Yu Liu, Professor (+8618640068209, liuyu@cmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment Score (time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention). The study lists 7 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 30 Jul 2026.