Effectiveness of Brain Dynamic Audio Stimulation for Improving Insomnia and Sleep Cycles in Healthcare Professionals (BDAS-HP)

Chi Mei Medical Foundation

Status: Invitation-only

Conditions: Sleep Disturbances and Insomnia

Treatments: Behavioral: Brain Dynamic Audio Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07252128

11404-012 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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 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 sleep 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- and post-intervention changes in ISI scores will be analyzed using paired statistical methods, while objective sleep parameters will be analyzed using appropriate comparative tests consistent with the exploratory nature of the study.

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: May 6, 2025).

Enrollment: 15 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Brain Dynamic Audio Stimulation

Experimental group

Description:

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

Treatment:

Behavioral: Brain Dynamic Audio Stimulation