- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07793045
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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Zhaojing Chen, Ph.D.
- 전화번호: 909-537-5358
- 이메일: zhaojing.chen@csusb.edu
연구 장소
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California
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San Bernardino, California, 미국, 92407
- 모병
- California State University, San Bernardino
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연락하다:
- Zhaojing Chen, Ph.D.
- 전화번호: 909-537-5358
- 이메일: zhaojing.chen@csusb.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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가짜 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intervention Feasibility
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Attention Performance
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB-FY2026-171
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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