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

August 28, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Bernardino, California, United States, 92407
        • Recruiting
        • California State University, San Bernardino
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Binaural Beats Stimulation (BBS)
Participants receive music containing embedded binaural beats.
Behavioral: 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.
Sham Comparator: Music Control
Participants receive similar music without embedded binaural beats.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Feasibility
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Attention Performance
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California State University, San Bernardino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 25, 2026

First Submitted That Met QC Criteria

August 25, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2026-171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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