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NCT Number: NCT07735910

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

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.

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Key information

Conditions

Mild Cognitive Impairment Anxiety Disorders Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Cognitive Function Depression Dyssomnias Mental Disorders Nervous System Diseases Neurocognitive Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jintaiyang Elderly Care Center, Huanggu Branch, Shenyang, Liaoning, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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:

  • 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.

Treatment and study plan

Binaural Beats Embedded in Old Songs

Behavioral

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 Songs

Behavioral

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.

Primary outcomes

  1. 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.

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Liu Yu Yu Liu, Professor

CONTACT

[email protected]

+8618640068209

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study title

The Effect of Binaural Beats on Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes: A Randomized Controlled Trial

Acronym: BB-MCI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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