Health TrialsbyHealthPanel

Binaural Beats Stimulation for Adults With Attention-Deficit/Hyperactivity Disorder

ConditionAttention-Deficit/Hyperactivity Disorder (ADHD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorCalifornia State University, San Bernardino

About this trial

This study is conducted entirely in person at California State University, San Bernardino. Participation requires 12 campus visits over six weeks. Remote participation is not available, and travel expenses are not reimbursed. Participants who complete all study visits will receive a gift valued at $25.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 at the CSUSB campus conducted twice weekly over six weeks -

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Music-Based Binaural Beats Stimulation

    Behavioral

    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.

  • Music Listening Without Binaural Beats

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Binaural Beats Stimulation (BBS)Experimental treatment 1 intervention
Group B: Music ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Throughout the six-week intervention
2

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.

Time frame
Throughout the six-week intervention

Secondary outcomes

1

Change in Attention Performance

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.

Time frame
Baseline and immediately after the six-week intervention
2

Change in Memory Performance

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.

Time frame
Baseline and immediately after the six-week intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

California State University, San Bernardino

Lead sponsor

Source ClinicalTrials.gov
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