ClinicalTrials.gg
RecruitingNCT07735910BB-MCIUpdated Jul 30, 2026

Binaural Beats for Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes

An interventional study of Binaural Beats Embedded in Old Songs and Old Songs in Mild Cognitive Impairment and Cognitive Function, sponsored by China Medical University, China. Recruiting at 3 sites in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by China Medical University, China · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Mild Cognitive Impairment
  • Cognitive Function

Keywords

  • Binaural Beats
  • Older Adults
  • Nursing Homes
  • Cognitive Function
  • Sleep Quality
  • Anxiety
  • Depression
  • Non-drug Intervention
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 60 is close to the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

China Medical University, China is the lead sponsor of 94 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Age 60 years or older.
  2. Not previously diagnosed with dementia.
  3. Meets the diagnostic criteria for mild cognitive impairment, with scores adjusted by education level, Mini-Mental State Examination score >= 24, and Activities of Daily Living score \< 23.
  4. Has lived in a nursing home for more than 2 months and plans to continue living there during the study period.
  5. No hearing impairment; Hearing Handicap Inventory for the Elderly-Screening Version score \< 8, and able to hear binaural beats through both ears.
  6. Conscious and able to cooperate with questionnaires and scale assessments.
  7. Has not taken medications that may affect cognitive function within 3 to 6 months before the intervention.

Exclusion criteria

Exclusion Criteria:

  1. Severe physical disease, major organ failure, or advanced malignant tumor.
  2. Diagnosed depression or other psychiatric disorders.

Withdrawal Criteria:

  1. 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.
  2. Voluntary withdrawal from the study.

Removal Criteria:

  1. Incomplete data resulting in missing information.
  2. Missing three or more intervention sessions within 2 weeks without following intervention instructions.
  3. Receiving other treatments or interventions related to cognitive function during the trial.
Terms in these criteria, in plain language(1)

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.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Binaural Beats Plus Old Songs Group

    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.

    Behavioral: Binaural Beats Embedded in Old Songs

  • Active comparator
    Old Songs Group

    Participants will listen to the same type of old songs without binaural beats through headphones once daily for 30 minutes for 14 consecutive days.

    Behavioral: Old Songs

Interventions

  • BehavioralBinaural Beats Embedded in Old Songs

    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.

  • BehavioralOld Songs

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention

  2. Change in Digit Span Test Score

    Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention

  3. Change in Stroop Color-Word Test Score

    Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention

  4. Change in Trail Making Test Score

    Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention

  5. Change in Pittsburgh Sleep Quality Index Score

    Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention

  6. Change in Geriatric Anxiety Scale Score

    Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention

  7. Change in Geriatric Depression Scale-15 Score

    Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention

07

Study locations

3 of 3 sites recruiting
  • Jintaiyang Jingguan Elderly Care Apartment
    Shenyang, Liaoning 110030, China
    Recruiting
  • Jintaiyang Elderly Care Center, Huanggu Branch
    Shenyang, Liaoning 110031, China
    Recruiting
  • Renai Changwan Elderly Care Home, Dadong District
    Shenyang, Liaoning 110042, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Sep 2026, 2 months after the start.

Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 2 months is below that.

Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2026
First posted
Jul 30, 2026
StartActual
Jun 15, 2026
Primary completionEst.
Sep 1, 2026
CompletionEst.
Sep 20, 2026
Last update
Jul 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07735910
Lead sponsor
China Medical University, China
Responsible party
Yuhan Geng (Graduate Student, China Medical University, China) — Principal investigator
First posted
Jul 30, 2026
Start date
Jun 15, 2026
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 20, 2026 (estimated)
Last update
Jul 30, 2026

Study contacts

Liu Yu Yu Liu, Professor
Contact
liuyu@cmu.edu.cn
+8618640068209

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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