NCT07793045

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Mar 2026Dec 2027

Study Start

First participant enrolled

March 3, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

1.7 years

First QC Date

August 25, 2026

Last Update Submit

August 25, 2026

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

Binaural Beat, ADHD

Outcome Measures

Primary Outcomes (2)

  • Intervention Feasibility

    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

    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 Outcomes (2)

  • Change in Attention Performance

    Baseline and immediately after the six-week intervention

  • Change in Memory Performance

    Baseline and immediately after the six-week intervention

Study Arms (2)

Binaural Beats Stimulation (BBS)

EXPERIMENTAL

Participants receive music containing embedded binaural beats.

Behavioral: Music-Based Binaural Beats Stimulation

Music Control

SHAM COMPARATOR

Participants receive similar music without embedded binaural beats.

Behavioral: Music Listening Without Binaural Beats

Interventions

Music-Based Binaural Beats StimulationBEHAVIORAL

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.

Binaural Beats Stimulation (BBS)
Music Listening Without Binaural BeatsBEHAVIORAL

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.

Music Control

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18 to 55 years
  • Previous diagnosis of ADHD made by a qualified healthcare professional and ADHD diagnosis supported by the Adult ADHD Self-Report Scale (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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California State University, San Bernardino

San Bernardino, California, 92407, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 20117669BACKGROUND

  • 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.

    PMID: 31982036BACKGROUND

  • 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.

    PMID: 35842538BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Zhaojing Chen, Ph.D.

CONTACT

909-537-5358zhaojing.chen@csusb.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned in parallel to either a six-week music-based binaural beat stimulation intervention or a control condition involving similar music without binaural beats.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Kinesiology

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 28, 2026

Study Start

March 3, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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 IRB-approved data-management procedures. Deidentified aggregate findings will be disseminated through conference presentations and peer-reviewed publications.

Locations

US(1)