Binaural Beats Stimulation for Adults With Attention-Deficit/Hyperactivity Disorder (BBS-ADHD)
Effects of Binaural Beats Stimulation on Attention and Memory in Adults With Attention-Deficit/Hyperactivity Disorder
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Zhaojing Chen, Ph.D.
- 電話番号：909-537-5358
- メール：zhaojing.chen@csusb.edu
研究場所
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California
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San Bernardino、California、アメリカ、92407
- 募集
- California State University, San Bernardino
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コンタクト：
- Zhaojing Chen, Ph.D.
- 電話番号：909-537-5358
- メール：zhaojing.chen@csusb.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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 conducted twice weekly over six weeks -
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Binaural Beats Stimulation (BBS)
Participants receive music containing embedded binaural beats.
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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.
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偽コンパレータ：Music Control
Participants receive similar music without embedded binaural beats.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intervention Feasibility
時間枠：Throughout the six-week intervention
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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.
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Throughout the six-week intervention
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Participant Acceptability
時間枠：Throughout the six-week intervention
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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.
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Throughout the six-week intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Attention Performance
時間枠：Baseline and immediately after the six-week intervention
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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.
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Baseline and immediately after the six-week intervention
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Change in Memory Performance
時間枠：Baseline and immediately after the six-week intervention
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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.
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Baseline and immediately after the six-week intervention
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Posner J, Polanczyk GV, Sonuga-Barke E. Attention-deficit hyperactivity disorder. Lancet. 2020 Feb 8;395(10222):450-462. doi: 10.1016/S0140-6736(19)33004-1. Epub 2020 Jan 23.
- Kennel S, Taylor AG, Lyon D, Bourguignon C. Pilot feasibility study of binaural auditory beats for reducing symptoms of inattention in children and adolescents with attention-deficit/hyperactivity disorder. J Pediatr Nurs. 2010 Feb;25(1):3-11. doi: 10.1016/j.pedn.2008.06.010. Epub 2009 Jun 3.
- Basu S, Banerjee B. Potential of binaural beats intervention for improving memory and attention: insights from meta-analysis and systematic review. Psychol Res. 2023 Jun;87(4):951-963. doi: 10.1007/s00426-022-01706-7. Epub 2022 Jul 16.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-FY2026-171
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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