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

NCT07735910 | Recruiting

• 1 other identifier: Lunshen [2025] 239
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Mild Cognitive Impairment; Cognitive Function

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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.

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.

Behavioral: Old Songs

Interventions

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.

Binaural Beats Plus Old Songs Group

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.

Old Songs Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (3)

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

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Liu Yu Yu Liu, Professor

CONTACT

+8618640068209; liuyu@cmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Model Details: Participants will be assigned to an intervention group or a control group to evaluate the effect of binaural beats on cognitive function.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

CN (3)