Binaural Beats for Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes (BB-MCI)
2026年7月27日 更新者：Yuhan Geng、China Medical University, China
The Effect of Binaural Beats on Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes: A Randomized Controlled Trial
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.
研究概览
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Liu Yu Yu Liu, Professor
- 电话号码：+8618640068209
- 邮箱：liuyu@cmu.edu.cn
学习地点
-
-
Liaoning
-
Shenyang、Liaoning、中国、110030
- 招聘中
- Jintaiyang Jingguan Elderly Care Apartment
-
接触：
- Yuhan Geng
- 电话号码：18018945883
- 邮箱：gengyuhan@cmu.edu.cn
-
Shenyang、Liaoning、中国、110031
- 招聘中
- Jintaiyang Elderly Care Center, Huanggu Branch
-
接触：
- Yuhan Geng
- 电话号码：18018945883
- 邮箱：gengyuhan@cmu.edu.cn
-
Shenyang、Liaoning、中国、110042
- 招聘中
- Renai Changwan Elderly Care Home, Dadong District
-
接触：
- Yuhan Geng
- 电话号码：18018945883
- 邮箱：gengyuhan@cmu.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Binaural Beats Plus Old Songs Group
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.
|
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.
|
|
有源比较器：Old Songs Group
Participants will listen to the same type of old songs without binaural beats through headphones once daily for 30 minutes for 14 consecutive days.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Montreal Cognitive Assessment Score
大体时间：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.
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
Change in Digit Span Test Score
大体时间：Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
|
Change in Stroop Color-Word Test Score
大体时间：Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
|
Change in Trail Making Test Score
大体时间：Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
|
Change in Pittsburgh Sleep Quality Index Score
大体时间：Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
|
Change in Geriatric Anxiety Scale Score
大体时间：Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
|
Change in Geriatric Depression Scale-15 Score
大体时间：Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月15日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年9月20日
研究注册日期
首次提交
2026年7月27日
首先提交符合 QC 标准的
2026年7月27日
首次发布 (实际的)
2026年7月30日
研究记录更新
最后更新发布 (实际的)
2026年7月30日
上次提交的符合 QC 标准的更新
2026年7月27日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.