Sleep Disturbances and InsomniaBDAS-HPNCT07252128
Effectiveness of Brain Dynamic Audio Stimulation for Improving Insomnia and Sleep Cycles in Healthcare Professionals: A Pilot Study
A study testing Brain Dynamic Audio Stimulation in people with Sleep Disturbances and Insomnia, run by Chi Mei Medical Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbances and Insomnia
- What is being tested?
- Brain Dynamic Audio Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Aug 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Pilot Interventional Study Investigating the Effects of Brain Dynamic Audio Stimulation on Insomnia and Sleep Cycles in Healthcare Professionals
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.
Read the detailed 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 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).
- Conditions
- Sleep Disturbances and Insomnia
- Being tested
- Brain Dynamic Audio Stimulation
- Keywords
- Sleep Disturbance, Healthcare Workers, Non-Pharmacological Intervention, Brain Dynamic Audio Stimulation
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Dynamic Audio StimulationBehavioural
Also called Brain Dynamic Audio
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Brain Dynamic Audio Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline (Day 0, prior to intervention) to post-intervention assessment (Day 14, after completion of two weeks of daily sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start14 Aug 2025
- Primary completion31 Mar 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Disturbances and InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chi Mei Medical Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Hong-Min, Chimei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252128
- Sponsor's protocol ID
- 11404-012
- Other IDs
- 11404-012
- Acronym
- BDAS-HP
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared outside the research team due to privacy protection of healthcare workers and institutional policy at Chi Mei Medical Center. Only aggregated and anonymized results will be published in academic journals or conferences.
Publications
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.
PubMed 23862643
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Interventional Study Investigating the Effects of Brain Dynamic Audio Stimulation on Insomnia and Sleep Cycles in Healthcare Professionals
- ClinicalTrials.gov ID
- NCT07252128
- Acronym / sponsor ID
- BDAS-HP / 11404-012
- Conditions
- Sleep Disturbances and Insomnia
- Keywords
- Sleep Disturbance, Healthcare Workers, Non-Pharmacological Intervention, Brain Dynamic Audio Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Chi Mei Medical HospitalUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brain Dynamic Audio Stimulation | Experimental | Behavioral: Brain Dynamic Audio StimulationParticipants 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Dynamic Audio StimulationAlso: Brain Dynamic AudioParticipants 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 | Behavioural | Brain Dynamic Audio Stimulation |
Primary outcome
Change in Insomnia Severity Index (ISI) Score
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 23862643Abeln 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.
- Chi Mei Medical Center Institutional Review BoardLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared outside the research team due to privacy protection of healthcare workers and institutional policy at Chi Mei Medical Center. Only aggregated and anonymized results will be published in academic journals or conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Dynamic Audio Stimulation in people with Sleep Disturbances and Insomnia, run by Chi Mei Medical Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) Score (time frame: From baseline (Day 0, prior to intervention) to post-intervention assessment (Day 14, after completion of two weeks of daily sessions).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07252128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.