Effects of Binaural Beats Stimulation on Attention and Memory in Adults With Attention-Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intervention Feasibility
研究概览
简要总结
This study is conducted entirely in person at California State University, San Bernardino. Participation requires 12 campus visits over six weeks. Remote participation is not available, and travel expenses are not reimbursed. Participants who complete all study visits will receive a gift valued at $25.
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are randomly assigned to listen to either music containing embedded binaural beats or similar music without binaural beats. Participants are not informed which listening condition they receive.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 55 years
- •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)
- •Willing to wear headphones during the listening sessions
- •Able and willing to attend 12 listening sessions at the CSUSB campus conducted twice weekly over six weeks -
排除标准
- •Anticipated absence from the study area for more than seven days during the two-month study period
- •Uncorrectable hearing impairment that would prevent adequate delivery of music through headphones
- •Acute psychiatric condition, such as depression
- •Intellectual or developmental disability that could interfere with study participation
- •Acute medical condition resulting in sensory impairment
- •Initiation of, or a change in dosage of, stimulant, antipsychotic, or analgesic medication within the previous month
- •Anticipated change in stimulant, antipsychotic, or analgesic medication during the study period
研究组 & 干预措施
Binaural Beats Stimulation (BBS)
Participants receive music containing embedded binaural beats.
干预措施: Music-Based Binaural Beats Stimulation (Behavioral)
Music Control
Participants receive similar music without embedded binaural beats.
干预措施: Music Listening Without Binaural Beats (Behavioral)
结局指标
主要结局
Intervention Feasibility
时间窗: 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.
Participant Acceptability
时间窗: 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.
次要结局
- Change in Attention Performance(Baseline and immediately after the six-week intervention)
- Change in Memory Performance(Baseline and immediately after the six-week intervention)
研究者
Zhaojing Chen
Associate Professor of Kinesiology
California State University, San Bernardino