Effects of Exposure to a Single-electrode Electroencephalography-guided Binaural Beat Audio Track on Sustained Attention and Subjective Well-being Among Healthy Adults

NCT07165899 | Completed

• 1 other identifier: IRB-FY2024-286
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the potential of binaural beats, adjusted in real-time via EEG feedback, to positively influence brain states related to relaxation, focus, and cognitive performance. The investigators are examining how these auditory techniques can improve memory, attention, and overall subjective well-being.

Conditions

Psychomotor Speed; Sustained Attention; Inhibitory Control; Memory Encoding; Well-being

Outcome Measures

Primary Outcomes (3)

• Stop Signal Reaction Time

  Estimated time (milliseconds) required to inhibit a prepotent response following a stop signal, derived from the integration method. Lower values indicate better inhibitory control.

  Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 10 minutes after completion of session).

• Reaction Time on Novelty Encoding Task

  Mean response latency (seconds) during the novelty encoding task recognition phase. Lower values indicate faster information retrieval and decision speed without implying a speed-accuracy trade-off. The unit of measurement is in seconds.

  Baseline (at visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).

• Predominant Frequency and Frequency Band from a Single Prefrontal Electrode

  EEG data were segmented into epochs and subjected to quality control procedures. For each epoch, sample entropy was calculated as a measure of signal irregularity. Epochs with entropy values above the 75th percentile were classified as high-noise and excluded from further analysis. The remaining epochs were standardized by z-scoring, transformed to the frequency domain, and then summarized into standard bands (delta: 0.5-4 Hz, theta: 4-8 Hz, low-alpha: 8-10 Hz, high-alpha: 10-12 Hz, low-beta: 12-18 Hz, high-beta: 18-32 Hz) to facilitate comparison across participants and conditions.

  The duration of the audio intervention was 30 minutes. Predominant frequency and frequency bands were measured as baseline, 5, 10, 15, 20, 25 minutes, and at the end of the session (at 30 minutes).

Secondary Outcomes (7)

• Visual Analogue Scale - Subjective Relaxation

  Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).

• Visual Analogue Scale - Sleepiness

  Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).

• Visual Analogue Scale - Focus

  Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).

• Visual Analogue Scale - Cognitive Performance

  Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).

• Visual Analogue Scale - Overall Well-Being

  Baseline (At visit 2 or 3, immediately prior to 30-minute intervention/control audio session) and immediately post-intervention/control audio session (within 20 minutes after completion of session).

Study Arms (2)

EEG-Guided Binaural Beat Audio

EXPERIMENTAL

30-minute audio session with dynamic frequency adjustments based on real-time EEG feedback

Behavioral: EEG-Guided Binaural Beat Audio

Sham Control

SHAM COMPARATOR

30-minute audio session with identical tones presented to both ears, EEG monitored but not used for frequency adjustment

Behavioral: Sham Control

Interventions

EEG-Guided Binaural Beat Audio BEHAVIORAL

30-minute audio session with dynamic frequency adjustments based on real-time EEG feedback

EEG-Guided Binaural Beat Audio

Sham Control BEHAVIORAL

30-minute audio session with identical tones presented to both ears (no binaural beat), EEG monitored but not used for frequency adjustment

Sham Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults (age \> 18 years)

You may not qualify if:

• Cognitive impairment (self-reported)
• Gross visual, auditory, or motor impairments; severe physical, psychiatric, or neurological impairments
• History of epilepsy, seizures, or seizure-like episodes
• History of intracranial lesions, stroke, traumatic brain injury, neoplasms, cranial surgery, or foreign bodies
• Current daily alcohol or substance abuse
• Current daily use of medications affecting EEG activity (e.g., anti-epileptics, opioids) or lowering seizure threshold
• Self-reported auditory hypersensitivity or prior adverse effects from audio stimulation

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center, Lubbock, TX, USA

Lubbock, Texas, 79430, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participants and research staff will be blinded to condition; randomization and condition assignment are automated within the PsychoPy script.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, double-blinded, sham-controlled, repeated-measures crossover design

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 10, 2025
• Study Start: August 16, 2024
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)