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

NCT07252128 | Enrolling By Invitation DMC

• 1 other identifier: 11404-012
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disturbances and Insomnia

Keywords

Sleep Disturbance; Healthcare Workers; Non-Pharmacological Intervention; Brain Dynamic Audio Stimulation

Outcome Measures

Primary Outcomes (2)

• Change in Insomnia Severity Index (ISI) Score

  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.

  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

  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.

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

Study Arms (1)

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

Behavioral: Brain Dynamic Audio Stimulation

Interventions

Brain Dynamic Audio Stimulation BEHAVIORAL

Participants will receive Brain Dynamic Audio Stimulation (BDAS), a non-pharmacological auditory intervention designed to support sleep initiation and improve sleep quality. The stimulation consists of frequency-modulated audio patterns delivered through headphones. Each participant will listen to a 30-minute session once daily for two consecutive weeks in a quiet, controlled environment. The intervention setting will be standardized to minimize external disturbances and ensure consistent delivery of the audio stimulation. The sound patterns are intended to facilitate relaxation and support the transition from wakefulness to sleep. Both subjective and objective sleep-related outcomes will be assessed before and after the intervention. Subjective sleep disturbance 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 distr

Also known as: Brain Dynamic Audio

Brain Dynamic Audio Stimulation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chi Mei Medical Hospital: lead

Study Sites (1)

Chi-Mei Medical Center

Tainan, Taiwan, 710, Taiwan

Location

Related Publications (1)

• Abeln V, Kleinert J, Struder HK, Schneider S. Brainwave entrainment for better sleep and post-sleep state of young elite soccer players - a pilot study. Eur J Sport Sci. 2014;14(5):393-402. doi: 10.1080/17461391.2013.819384. Epub 2013 Jul 18.

  PMID: 23862643 BACKGROUND

Related Links

• Chi Mei Medical Center Institutional Review Board

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Family Medicine

Model Details: This is a single-group, pretest-posttest pilot interventional study evaluating the effects of Brain Dynamic Audio Stimulation on sleep quality among healthcare professionals with subjective sleep disturbances. All participants receive the same intervention and serve as their own controls.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: August 14, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)