Binaural Beats Stimulation for Adults With Attention-Deficit/Hyperactivity Disorder (BBS-ADHD)
28 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zhaojing Chen, Ph.D.
- Número de teléfono: 909-537-5358
- Correo electrónico: zhaojing.chen@csusb.edu
Ubicaciones de estudio
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California
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San Bernardino, California, Estados Unidos, 92407
- Reclutamiento
- California State University, San Bernardino
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Contacto:
- Zhaojing Chen, Ph.D.
- Número de teléfono: 909-537-5358
- Correo electrónico: zhaojing.chen@csusb.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
|
|
Comparador falso: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intervention Feasibility
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Attention Performance
Periodo de tiempo: 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.
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Baseline and immediately after the six-week intervention
|
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Change in Memory Performance
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de marzo de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
25 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de agosto de 2026
Publicado por primera vez (Actual)
28 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-FY2026-171
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .