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Binaural Beats Stimulation for Adults With Attention-Deficit/Hyperactivity Disorder (BBS-ADHD)

2026年8月28日 更新者：Zhaojing Chen、California State University, San Bernardino

Effects of Binaural Beats Stimulation on Attention and Memory in Adults With Attention-Deficit/Hyperactivity Disorder

This study will evaluate the feasibility and potential effects of a six-week, music-based binaural beats stimulation program in adults with attention-deficit/hyperactivity disorder (ADHD). Forty adults with ADHD will be randomly assigned to either a binaural beat stimulation group or a control group. Both groups will attend 12 supervised listening sessions over six weeks and listen to similar music for 20 minutes per session; however, only the intervention group's music will contain embedded binaural beats. Cognitive assessments will be completed before and after the intervention to evaluate changes in attention and memory. Session attendance and participant retention will also be examined to assess the feasibility and acceptability of the program.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This randomized controlled study will examine the feasibility, acceptability, and preliminary effects of a six-week, music-based binaural beats stimulation (BBS) intervention in adults with attention-deficit/hyperactivity disorder (ADHD). The study aims to enroll 40 adults between 18 and 55 years of age with a previous ADHD diagnosis. Participants will be randomly assigned to either the BBS intervention group or the control group, with approximately 20 participants in each group.

During the first study visit, participants will provide informed consent and complete demographic and mental health questionnaires. ADHD symptoms will be assessed using the Adult ADHD Self-Report Scale. Participants will also complete baseline cognitive assessments using the CogniFit Research platform. The assessment battery will evaluate cognitive abilities related to attention, memory, coordination, and reasoning.

Participants will then attend 12 supervised listening sessions over six weeks, with two sessions conducted each week. Each listening session will include 20 minutes of music delivered through headphones. Participants assigned to the intervention group will listen to music containing embedded binaural beats, while participants assigned to the control group will listen to similar music without binaural beats. Before each listening session, participants will rest quietly for five minutes, after which heart rate and blood pressure will be measured and readiness to participate will be assessed.

After the six-week intervention, participants will complete the same cognitive assessment battery administered at baseline. Changes in cognitive outcomes from baseline to six weeks will be compared between the intervention and control groups. Session attendance and participant retention will also be evaluated as indicators of intervention feasibility and acceptability.

研究类型

介入性

注册 (估计的)

40

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

学习地点

  • 美国
    • California
      • San Bernardino、California、美国、92407
        • 招聘中
        • California State University, San Bernardino
        • 接触：

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

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Adults aged 18 to 55 years
  2. Previous diagnosis of attention-deficit/hyperactivity disorder (ADHD) made by a qualified healthcare professional and supported by the Adult ADHD Self-Report Scale, version 1.1 (ASRS-v1.1)
  3. Willing to wear headphones during the listening sessions
  4. Able and willing to attend 12 listening sessions conducted twice weekly over six weeks -

Exclusion Criteria:

  1. Anticipated absence from the study area for more than seven days during the two-month study period
  2. Uncorrectable hearing impairment that would prevent adequate delivery of music through headphones
  3. Acute psychiatric condition, such as depression
  4. Intellectual or developmental disability that could interfere with study participation
  5. Acute medical condition resulting in sensory impairment
  6. Initiation of, or a change in dosage of, stimulant, antipsychotic, or analgesic medication within the previous month
  7. Anticipated change in stimulant, antipsychotic, or analgesic medication during the study period

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：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Binaural Beats Stimulation (BBS)
Participants receive music containing embedded binaural beats.
行为的：Music-Based Binaural Beats Stimulation
Participants will receive 12 supervised binaural beats stimulation sessions over six weeks, with two sessions conducted per week. During each session, participants will listen through headphones to 20 minutes of music containing embedded binaural beats. Music will be selected based on each participant's preferred genre from available options.
假比较器：Music Control
Participants receive similar music without embedded binaural beats.
行为的：Music Listening Without Binaural Beats
Participants will receive 12 supervised music-listening sessions over six weeks, with two sessions conducted per week. During each session, participants will listen through headphones to 20 minutes of music without embedded binaural beats. The music, listening duration, session schedule, setting, and available genre options will be similar to those provided to the experimental group.

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
Intervention Feasibility
大体时间：Throughout the six-week intervention
Feasibility will be evaluated using the numbers of participants screened, eligible, and enrolled; the proportion of enrolled participants who complete the intervention and post-intervention assessments; and the number and percentage of the 12 scheduled listening sessions completed by each participant.
Throughout the six-week intervention
Participant Acceptability
大体时间：Throughout the six-week intervention
Acceptability will be assessed during each intervention session by documenting changes in health status, perceived positive or negative effects, and any discomfort or concerns. After each session, participants will rate their enjoyment on a 5-point scale ranging from 1 (not at all enjoyable) to 5 (extremely enjoyable) and provide open-ended feedback about their mood, emotions, relaxation, and other perceived effects. Responses will be summarized descriptively.
Throughout the six-week intervention

次要结果测量

结果测量
措施说明
大体时间
Change in Attention Performance
大体时间：Baseline and immediately after the six-week intervention
Change from baseline in attention-related performance measured using the CogniFit cognitive assessment battery, including the Psychomotor Vigilance Test, Stroop Test, and Divided Attention Test. Changes of the scores will be interpreted according to the scoring method for each CogniFit test.
Baseline and immediately after the six-week intervention
Change in Memory Performance
大体时间：Baseline and immediately after the six-week intervention
Change from baseline in memory-related performance measured using the CogniFit cognitive assessment battery, including the Visual Working Memory Span Test and Multimodal Lexical Memory Test. Changes of the scores will be interpreted according to the scoring method for each CogniFit test.
Baseline and immediately after the six-week 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。

赞助

California State University, San Bernardino

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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3月3日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年8月25日

首先提交符合 QC 标准的

2026年8月25日

首次发布 (实际的)

2026年8月28日

研究记录更新

最后更新发布 (实际的)

2026年9月1日

上次提交的符合 QC 标准的更新

2026年8月28日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB-FY2026-171

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared because the dataset contains sensitive mental health and cognitive information, and external sharing of participant-level data is not included in the current informed-consent and Institutional Review Board (IRB)-approved data-management procedures. Deidentified aggregate findings will be disseminated through conference presentations and peer-reviewed publications.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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