CompletedNot Applicable

Effectiveness of Brain Dynamic Audio Stimulation for Improving Insomnia and Sleep Cycles in Healthcare Professionals: A Pilot Study

Taiwan15 participantsStarted 2025-08-14

Plain-language summary

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.

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Insomnia Severity Index (ISI) Score

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

Change in EEG-Derived Sleep Parameters

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

Trial details

NCT IDNCT07252128

SponsorChi Mei Medical Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Sleep Disturbances and Insomnia trials

Plain-language summary

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Insomnia Severity Index (ISI) Score

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

Change in EEG-Derived Sleep Parameters

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