A Prospective Pilot Interventional Study Investigating the Effects of Brain Dynamic Audio Stimulation on Insomnia and Sleep Cycles in Healthcare Professionals
Phase: NA
Conditions: Sleep Disturbances and Insomnia
Sponsor: Chi Mei Medical Hospital

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Study Document Cover Page 
Official Title: Brain Dynamic Audio Stimulation for Improving Sleep Quality and Circadian 
Rhythm in Healthcare Workers 
Short Title: Brain Dynamic Audio Stimulation 
Document Type: Study Protocol 
IRB Number: CMMC IRB No. 11404-012 
Organization Name: Chi Mei Medical Center (CMMC) 
Principal Investigator: Hong-Min, Lin 
Document Date: 2025-10-21 
Version: 1.0 
Confidentiality Statement: This document contains confidential information intended for 
regulatory and research purposes only. 
 
 

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Study Protocol 
Title: 
Effectiveness of Brain Dynamic Audio Stimulation for Improving Insomnia and Sleep Cycles 
in Healthcare Professionals (BDAS-HP) 
Protocol ID: 11404-012 
Institution: Chi Mei Medical Center, Tainan, Taiwan 
Principal Investigator: Hong-Min Lin, MD 
IRB Number: CMMC IRB No. 11404-012 
Approval Date: May 6, 2025 
Document Date: January 1, 2026 
Version: 2.0 
1. Background and Rationale 
Healthcare professionals are at high risk of insomnia and impaired sleep quality due to shift 
work, occupational stress, and high cognitive demands. Poor sleep is associated with 
decreased attention, emotional dysregulation, burnout, and increased medical errors. 
Brain Dynamic Audio Stimulation (BDAS) is a non-invasive auditory intervention that 
delivers frequency-specific sound patterns designed to entrain neural oscillations 
toward brainwave frequencies associated with relaxation and sleep, particularly theta (θ) 
and delta (δ) bands. This mechanism is hypothesized to facilitate sleep initiation and improve 
sleep stability. 
The present study aims to evaluate the clinical feasibility and preliminary effectiveness of 
BDAS using both subjective outcomes (Insomnia Severity Index, ISI) and objective 
sleep-related parameters derived from short-duration polysomnographic EEG recordings, 
sleep onset latency, and sleep efficiency. 
2. Objectives 
Primary Objective: 
To evaluate changes in insomnia severity, measured by the Insomnia Severity Index (ISI), 
before and after BDAS intervention. 
Secondary Objective: 
To assess changes in: 
• 
Sleep onset success rate 
• 
Sleep onset latency 

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• 
Sleep efficiency following BDAS exposure 
To explore short-term changes in sleep stage distribution using EEG-based sleep 
hypnograms. 
 
3. Study Design 
This is a prospective, single-group, pretest-posttest interventional study. 
Fifteen healthcare professionals aged 20–65 years with subjective sleep disturbances will be 
recruited. Participants will undergo a 30-minute BDAS session daily for two consecutive 
weeks in a controlled environment at Chi Mei Medical Center. 
Pre- and post-intervention assessments include ISI and quantitative EEG recordings. 
4. Participants 
Inclusion Criteria 
• 
Licensed healthcare workers at Chi Mei Medical Center (nurses, physicians, therapists, 
social workers). 
• 
Age 20–65 years. 
• 
Subjective sleep disturbance for at least one month. 
• 
Willing and able to participate for two weeks. 
• 
Provided written informed consent. 
Exclusion Criteria 
• 
Current use of hypnotics, antidepressants, or psychiatric medications. 
• 
Diagnosed sleep disorders (e.g., OSA, narcolepsy). 
• 
Neurological or psychiatric illness, epilepsy, or severe chronic disease. 
• 
Hearing impairment affecting audio perception. 
• 
Pregnancy or breastfeeding. 
5. Intervention: Brain Dynamic Audio Stimulation (BDAS) 
Participants will receive 30 minutes of BDAS each night for 14 days. 
The audio files consist of sound frequencies designed to entrain brainwave patterns 
associated with deep relaxation (delta, theta) and restorative sleep. 
Sessions will take place in a quiet, dimly lit room under standardized conditions. 
No pharmacological agents will be administered. 
6. Outcome Measures 

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Primary Outcome: 
Subjective Outcome 
• 
Insomnia Severity Index (ISI) 
o Baseline (pre-intervention) 
o Post-intervention (after 2 weeks of BDAS use) 
Objective Outcomes 
• 
EEG-derived sleep hypnogram based on AASM criteria 
• 
Sleep onset success rate 
• 
Sleep onset latency (seconds) 
• 
Sleep efficiency (sleep time / total recording time) 
EEG, EOG, and EMG signals are used to infer sleep stages (Wake, N1, N2, N3, REM). 
7. Statistical Analysis 
ISI Score Analysis 
• 
Paired-sample t-tests to compare pre- and post-intervention ISI scores 
• 
Effect sizes calculated using Cohen’s d and Hedges’ g 
Sleep Onset Latency Analysis 
• 
Independent-sample t-tests are used to compare latency before and after two weeks of 
use 
• 
Each sleep session is treated as an independent observation to maximize statistical 
power 
Sleep Efficiency Analysis 
• 
Independent-sample t-tests comparing pre-intervention and post-intervention sleep 
efficiency 
• 
Effect sizes reported using Cohen’s d and Hedges’ g 
Statistical Significance 
• 
Two-tailed tests 
• 
p < 0.05 considered statistically significant 
 

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8. Ethical Considerations 
This study was approved by the Institutional Review Board of Chi Mei Medical Center (IRB 
No. 11404-012). 
All participants will provide written informed consent prior to enrollment. 
Participants can withdraw at any time without penalty. 
9. Data Management 
All participant data will be de-identified and stored on secure, 
password-protected institutional servers. 
Only authorized investigators will have access. 
Data will be used solely for research and academic publication purposes. 
10. Dissemination and IPD Sharing Statement 
Individual participant data will not be shared outside the research team due to 
institutional confidentiality policies. 
Aggregated and anonymized results will be presented in scientific conferences 
and peer-reviewed journals. 
11. Contacts and Location 
Principal Investigator: 
Dr. Hong-Min Lin 
Department of Family Medicine 
Chi Mei Medical Center 
No. 901, Zhonghua Road, Yongkang District, Tainan City 710, Taiwan (R.O.C.) 
Email: hongml2828@gmail.com | Tel: +886-6-2812811 
IRB Contact: 
Chi Mei Medical Center IRB 
cmhirb@mail.chimei.org.tw | +886-6-6222547