Binaural Beats for Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Binaural Beats Embedded in Old Songs, Old Songs.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment, Cognitive Function. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Binaural Beats on Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes: A Randomized Controlled Trial
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Change in Montreal Cognitive Assessment Score [Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
- Change in Digit Span Test Score [Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
- Change in Stroop Color-Word Test Score [Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
- Change in Trail Making Test Score [Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
- Change in Pittsburgh Sleep Quality Index Score [Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
- Change in Geriatric Anxiety Scale Score [Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
- Change in Geriatric Depression Scale-15 Score [Time frame: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Jintaiyang Jingguan Elderly Care Apartment — Shenyang
- Jintaiyang Elderly Care Center, Huanggu Branch — Shenyang
- Renai Changwan Elderly Care Home, Dadong District — Shenyang
Identifiers
NCT: NCT07735910 · Lunshen [2025] 239