The Effect of Binaural Beats on Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in Geriatric Depression Scale-15 Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Geriatric Depression Scale-15 Score
时间窗: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Trail Making Test Score
时间窗: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Pittsburgh Sleep Quality Index Score
时间窗: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Montreal Cognitive Assessment Score
时间窗: 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
时间窗: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Stroop Color-Word Test Score
时间窗: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
Change in Geriatric Anxiety Scale Score
时间窗: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
次要结局
未报告次要终点
研究者
Yuhan Geng
Graduate Student
China Medical University, China