Effects of Exposure to a Single-electrode Electroencephalography-guided Binaural Beat Audio Track on Sustained Attention and Subjective Well-being Among Healthy Adults: a Randomized, Double-blinded, Sham-controlled Repeated-measures Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Stop Signal Reaction Time
研究概览
简要总结
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.
详细描述
With the existence of a strong evidence base regarding audio-assisted relaxation, audio products are widely used globally to achieve relaxed and focused mental states. The utility of audio for achieving relaxed mental states has revolutionized with the advent of the concept of binaural beats, an auditory phenomenon that is induced by separately presenting two tones of different frequencies to each ear. The superior olivary nucleus of the midbrain computes the difference between the two tones, and with time, the brain state is expected to synchronize with the difference in the frequencies presented to the two ears. Binaural beats are widely used to achieve relaxed mental states for applications including improved memory, enhanced relaxation, augmented hypnotherapy, improved sleep quality, creating and breaking habits, addiction therapy, and enhanced cognitive performance with limited empirical support.
Electroencephalography (EEG) is a well-established technique for recording the electrical activity of the brain. This is conventionally achieved through the placement of multiple electrodes across the scalp, allowing for the detection of the brain's spontaneous electrical activity over a period of time. EEG measures voltage fluctuations resulting from ionic current flows within the neurons of the brain. Single-electrode electroencephalography simplifies the conventional approach by using one electrode placed at a strategic location on the scalp. When recorded over the pre-frontal cortex, this method allows for capturing the electrical activity of the brain's frontal lobe, which is responsible for high-level cognitive functions and behavior. EEG waves are typically divided into bandwidths known as frequency bands. These are characterized based on their frequency, which is measured in cycles per second (Hz), and include:
Delta waves (0 to 4 Hz): Associated with deep sleep and certain pathological conditions.
Theta waves (4.1 to 8 Hz): Linked to drowsiness, early stages of sleep, and meditation.
Low Alpha waves (8.1 to 10 Hz): Related to relaxed, calm, and resting states. High Alpha waves (10.1 to 14 Hz): Often associated with a state of wakeful relaxation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Both participants and research staff will be blinded to condition; randomization and condition assignment are automated within the PsychoPy script.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adults (age > 18 years)
排除标准
- •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
研究组 & 干预措施
EEG-Guided Binaural Beat Audio
30-minute audio session with dynamic frequency adjustments based on real-time EEG feedback
干预措施: EEG-Guided Binaural Beat Audio (Behavioral)
Sham Control
30-minute audio session with identical tones presented to both ears, EEG monitored but not used for frequency adjustment
干预措施: Sham Control (Behavioral)
结局指标
主要结局
Stop Signal Reaction Time
时间窗: 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).
Estimated time (milliseconds) required to inhibit a prepotent response following a stop signal, derived from the integration method. Lower values indicate better inhibitory control.
Reaction Time on Novelty Encoding Task
时间窗: 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).
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.
Predominant Frequency and Frequency Band from a Single Prefrontal Electrode
时间窗: 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).
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.
次要结局
- 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).)
- Hit Rate of Novelty Encoding Task(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 - 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 - 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).)
- False Alarm Rate of Novelty Encoding Task(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).)
研究者
Samudani Dhanasekara
Assistant Professor
Texas Tech University Health Sciences Center