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Clinical Trials in China / NCT07735910
Recruiting Not applicable

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

NCT07735910 · tracked via the Priya Life Science China tracker
Sponsor
China Medical University, China
Phase
Not applicable
Started
2026-06-15
Last updated
2026-07-30

Condition(s) studied

Mild Cognitive ImpairmentCognitive Function

Investigational drug(s) / intervention(s)

Binaural Beats Embedded in Old SongsOld Songs

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.

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.

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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in Montreal Cognitive Assessment Score — 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 — 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

Trial sites (3)

FacilityCityRegionStatus
Jintaiyang Jingguan Elderly Care Apartment Shenyang Liaoning Recruiting
Jintaiyang Elderly Care Center, Huanggu Branch Shenyang Liaoning Recruiting
Renai Changwan Elderly Care Home, Dadong District Shenyang Liaoning Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07735910 on ClinicalTrials.gov ↗ ← All trials in China