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临床试验/NCT07252128
NCT07252128已完成不适用

A Prospective Pilot Interventional Study Investigating the Effects of Brain Dynamic Audio Stimulation on Insomnia and Sleep Cycles in Healthcare Professionals

Chi Mei Medical Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年8月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Change in Insomnia Severity Index (ISI) Score

研究概览

简要总结

This study aims to evaluate the effectiveness of Brain Dynamic Audio Stimulation (BDAS) in improving sleep quality among healthcare professionals experiencing insomnia. Healthcare workers are frequently exposed to high occupational stress, irregular work schedules, and sleep disturbances, which may adversely affect mental well-being, cognitive performance, and clinical care.

Participants will use BDAS once daily for 30 minutes over a two-week period under standardized conditions. Both subjective and objective sleep-related outcomes will be assessed. Subjective sleep quality will be evaluated using the Insomnia Severity Index (ISI). Objective sleep parameters will be derived from short-duration EEG-based sleep recordings, including measures of sleep onset, sleep efficiency, and sleep stage distribution based on standardized scoring criteria.

This study seeks to determine whether audio-based neural entrainment through BDAS can facilitate sleep initiation and improve sleep efficiency in a real-world healthcare setting. As a non-pharmacological and non-invasive intervention, BDAS may offer healthcare professionals a safe and practical approach to managing insomnia and supporting overall well-being.

详细描述

Sleep disorders are recognized by the World Health Organization as a major global health issue, particularly among healthcare professionals exposed to high occupational stress and irregular work schedules. Although conventional pharmacological treatments for insomnia can be effective, they are often associated with adverse effects and the risk of dependence. Consequently, non-pharmacological approaches have gained increasing attention. Among these, audio-based brainwave entrainment has been proposed as a potential method to facilitate sleep initiation and stabilization through neural synchronization mechanisms.

This prospective pilot interventional study adopts a single-group pretest-posttest design to evaluate the effects of Brain Dynamic Audio Stimulation (BDAS) on sleep quality in healthcare professionals. A total of 15 participants aged 20-65 years who report subjective sleep disturbances will be recruited from Chi Mei Medical Center, including nurses, physicians, therapists, and other allied healthcare workers. Exclusion criteria include recent use of hypnotics or psychotropic medications, diagnosed sleep disorders, and a history of major psychiatric, neurological, or severe chronic illnesses.

Participants will use BDAS once nightly for two consecutive weeks. Objective sleep-related data will be collected using short-duration EEG-based recordings before and after the intervention to assess sleep onset, sleep efficiency, and sleep stage distribution in accordance with standardized sleep scoring criteria. Subjective sleep outcomes will be evaluated using the Insomnia Severity Index (ISI).

Pre-post changes in ISI scores will be analyzed using paired-sample t tests, with effect sizes estimated using Cohen's d. EEG-derived sleep parameters will be analyzed using paired-sample t tests at the participant level for sleep onset latency and unpaired t tests at the recording-session level for sleep efficiency, reflecting the exploratory nature of the study. Effect sizes will be reported using Cohen's d or Hedges' g.

All study data will be de-identified and securely stored on password-protected institutional servers accessible only to authorized research personnel. Participation is voluntary, and participants may withdraw at any time without penalty. This study has been approved by the Institutional Review Board of Chi Mei Medical Center (IRB No. 11404-012; approval date: August 14, 2025).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Licensed healthcare workers currently employed at Chi Mei Medical Center.
  • •Aged between 20 and 65 years.
  • •Experiencing subjective sleep disturbance or poor sleep quality for at least one month.
  • •Willing to participate in the Brain Dynamic Audio Stimulation sessions for two consecutive weeks.
  • •Able to provide informed consent and complete questionnaires and EEG assessments.

排除标准

  • •Current use of sedative-hypnotic medication, psychiatric medication, or other sleep-related pharmacotherapy.
  • •Diagnosed sleep disorders (e.g., obstructive sleep apnea, narcolepsy, restless legs syndrome).
  • •History of epilepsy, major psychiatric illness, or neurological disorder.
  • •Significant hearing impairment that interferes with audio stimulation.
  • •Pregnant or breastfeeding women.

研究组 & 干预措施

Brain Dynamic Audio Stimulation

Experimental

Participants in this experimental arm will receive Brain Dynamic Audio Stimulation (BDAS), a non-pharmacological auditory intervention designed to support sleep initiation and improve sleep quality. Each participant will use BDAS for 30 minutes once daily over two consecutive weeks in a controlled environment within Chi Mei Medical Center.

The intervention will be delivered in a quiet and private setting to minimize external disturbances and ensure standardized conditions across sessions. The audio stimulation consists of frequency-modulated sound patterns intended to facilitate relaxation and support sleep onset.

Pre- and post-intervention assessments will include the Insomnia Severity Index (ISI) as a subjective measure of sleep disturbance, as well as short-duration EEG-based sleep recordings. Objective sleep-related outcomes will be derived from EEG data, including sleep onset, sleep efficiency, and sleep stage distribution, in accordance with standardized sleep scoring criteria

干预措施: Brain Dynamic Audio Stimulation (Behavioral)

结局指标

主要结局

Change in Insomnia Severity Index (ISI) Score

时间窗: From baseline (Day 0, prior to intervention) to post-intervention assessment (Day 14, after completion of two weeks of daily sessions).

The Insomnia Severity Index (ISI) will be used to assess subjective insomnia severity before and after the intervention. The ISI is a validated 7-item self-reported questionnaire evaluating the severity, nature, and impact of insomnia symptoms, with each item rated on a 0-4 scale (total score range: 0-28). Higher scores indicate greater insomnia severity. The primary outcome is the within-participant change in total ISI score following Brain Dynamic Audio Stimulation, reflecting changes in perceived sleep disturbance among healthcare professionals.

Change in EEG-Derived Sleep Parameters

时间窗: From baseline (Day 0, prior to intervention) to post-intervention assessment (Day 14, after completion of two weeks of daily sessions).

Electroencephalography (EEG) will be used to derive objective sleep-related parameters before and after the Brain Dynamic Audio Stimulation intervention. Short-duration EEG-based sleep recordings will be analyzed to assess changes in sleep onset, sleep efficiency, and sleep stage distribution, based on standardized sleep scoring criteria. Pre- and post-intervention comparisons will be performed to evaluate objective changes in sleep patterns following the intervention.

次要结局

未报告次要终点

研究者

发起方
Chi Mei Medical Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin Hong-Min

Principal Investigator, Department of Family Medicine

Chimei Medical Center

研究点 (1)

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