Cognitive Function, Mild Cognitive Impairment
Conditions
Keywords
Binaural Beats, Older Adults, Nursing Homes, Cognitive Function, Sleep Quality, Anxiety, Depression, Non-drug Intervention
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.
Interventions
BEHAVIORALBinaural 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.
BEHAVIORALOld 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.
Sponsors
China Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will be assigned to an intervention group or a control group to evaluate the effect of binaural beats on cognitive function.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
CONTACTLiu Yu Yu Liu, Professor
Outcome results
None listed