Binaural Beats for Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes (BB-MCI)

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Cognitive Function
• Intervention / Treatment: Behavioral: Binaural Beats Embedded in Old Songs; Behavioral: Old Songs

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu Yu Yu Liu, Professor; Phone Number: +8618640068209; Email: liuyu@cmu.edu.cn

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110030
      • Recruiting
      • Jintaiyang Jingguan Elderly Care Apartment
      • Contact: Yuhan Geng; Phone Number: 18018945883; Email: gengyuhan@cmu.edu.cn
    • Shenyang, Liaoning, China, 110031
      • Recruiting
      • Jintaiyang Elderly Care Center, Huanggu Branch
      • Contact: Yuhan Geng; Phone Number: 18018945883; Email: gengyuhan@cmu.edu.cn
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Renai Changwan Elderly Care Home, Dadong District
      • Contact: Yuhan Geng; Phone Number: 18018945883; Email: gengyuhan@cmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 60 years or older.
2. Not previously diagnosed with dementia.
3. 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.
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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Digit Span Test Score		Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Stroop Color-Word Test Score		Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Trail Making Test Score		Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Pittsburgh Sleep Quality Index Score		Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Geriatric Anxiety Scale Score		Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Geriatric Depression Scale-15 Score		Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention

Collaborators and Investigators

• Sponsor: China Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 20, 2026

Study Registration Dates

• First Submitted: July 27, 2026
• First Submitted That Met QC Criteria: July 27, 2026
• First Posted (Actual): July 30, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Older Adults; Sleep Quality; Cognitive Function; Nursing Homes; Binaural Beats; Non-drug Intervention
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Cognition Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Anxiety Disorders; Cognitive Dysfunction; Depression; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: Lunshen [2025] 239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No