Sleep DisturbancesNCT07909187
Effects of Brainwave Audio on Sleep in People With Sleep Disturbances
A study testing Brainwave Audio in people with Sleep Disturbances, run by Kaohsiung Armed Forces General Hospital at 1 site in Taiwan.
Trial summary
This exploratory study examines changes in sleep patterns during a four-week auditory stimulation intervention in 30 adults with self-reported sleep difficulties. Participants use an 18-minute programmed audio recording daily before sleep for four weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Disturbances
- What is being tested?
- Brainwave Audio
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jul 2025to 27 Nov 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults.
Who cannot join
- Hearing impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigate the Effectiveness of Brainwave Audio Intervention in Improving Sleep Cycles Among Individuals With Sleep Disturbances
This exploratory study examines changes in sleep patterns during a four-week auditory stimulation intervention in 30 adults with self-reported sleep difficulties.
Participants use an 18-minute programmed audio recording daily before sleep for four weeks. The recording combines natural environmental sounds, rhythmic sound components, and background noise. Listening volume can be adjusted to a comfortable level.
Read more
Sleep assessments are conducted at the beginning of the study, Week 2, and Week 4. Each assessment lasts 24 minutes and includes 3 minutes of silence before the audio, 18 minutes of audio, and 3 minutes of silence afterward. Brain activity, eye movements, and chin muscle activity are recorded to classify wakefulness and non-rapid eye movement sleep stages.
This study evaluates whether brainwave audio intervention can improve sleep in people with sleep disturbances. Participants listen to the study audio, and their sleep is assessed before and after the intervention to examine changes in sleep patterns.
- Conditions
- Sleep Disturbances
- Being tested
- Brainwave Audio
- Keywords
- Auditory stimulation, Brainwave audio, Sleep stages, Sleep-state transitions, Electroencephalography
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainwave AudioBehavioural
Participants listen to an 18-minute programmed audio recording daily before sleep for four weeks. The recording combines natural environmental sounds, rhythmic sound components, and background noise. All participants use the same audio program, with the listening volume adjusted to a comfortable level.
| Study group | Role | What they receive |
|---|---|---|
| Brainwave Audio | Experimental | An 18-minute programmed audio recording combining natural environmental sounds, rhythmic sound components, and background noise. Participants listen daily before sleep for four weeks at a comfortable volume. Receives: Behavioral: Brainwave Audio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth Sleepiness Scale (ESS)
Daytime sleepiness is assessed using the Epworth Sleepiness Scale (ESS). Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. Changes are calculated by comparing post-intervention scores with baseline scores.
Measured: All participants receive daily auditory stimulation for four weeks, with assessments at baseline, Week 2, and Week 4.
Secondary outcomes (1)
Electroencephalography (EEG)
Electroencephalography (EEG) is used to assess changes in brain activity. Power in the delta, theta, alpha, and beta frequency bands is compared between baseline and the post-intervention assessment.
Measured: All participants receive daily auditory stimulation for four weeks, with assessments at baseline, Week 2, and Week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start9 Jul 2025
- Primary completion30 Oct 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbancesStudies 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
- Single-group study in which all participants receive daily auditory stimulation for four weeks, with assessments at baseline, Week 2, and Week 4. No comparison group is included.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Armed Forces General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Tzu Chang, MD, Principal investigator, Kaohsiung Armed Forces General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909187
- Sponsor's protocol ID
- KAFGH_D_114089
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on sharing individual participant data has not yet been made. Any future sharing will be subject to participant consent, privacy protection, and applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Effectiveness of Brainwave Audio Intervention in Improving Sleep Cycles Among Individuals With Sleep Disturbances
- ClinicalTrials.gov ID
- NCT07909187
- Acronym / sponsor ID
- KAFGH_D_114089
- Conditions
- Sleep Disturbances
- Keywords
- Auditory stimulation, Brainwave audio, Sleep stages, Sleep-state transitions, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kaohsiung Armed Forces General HospitalUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 2 Nov 2026 (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 exploratory study examines changes in sleep patterns during a four-week auditory stimulation intervention in 30 adults with self-reported sleep difficulties.
Participants use an 18-minute programmed audio recording daily before sleep for four weeks. The recording combines natural environmental sounds, rhythmic sound components, and background noise. Listening volume can be adjusted to a comfortable level.
Sleep assessments are conducted at the beginning of the study, Week 2, and Week 4. Each assessment lasts 24 minutes and includes 3 minutes of silence before the audio, 18 minutes of audio, and 3 minutes of silence afterward. Brain activity, eye movements, and chin muscle activity are recorded to classify wakefulness and non-rapid eye movement sleep stages.
This study evaluates whether brainwave audio intervention can improve sleep in people with sleep disturbances. Participants listen to the study audio, and their sleep is assessed before and after the intervention to examine changes in sleep patterns.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group study in which all participants receive daily auditory stimulation for four weeks, with assessments at baseline, Week 2, and Week 4. No comparison group is included.
| Arm | Type | Receives |
|---|---|---|
| Brainwave Audio | Experimental | Behavioral: Brainwave AudioAn 18-minute programmed audio recording combining natural environmental sounds, rhythmic sound components, and background noise. Participants listen daily before sleep for four weeks at a comfortable volume. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults.
Key exclusion criteria (1 listed)
- Hearing impairment.
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 |
|---|---|---|
| Brainwave AudioParticipants listen to an 18-minute programmed audio recording daily before sleep for four weeks. The recording combines natural environmental sounds, rhythmic sound components, and background noise. All participants use the same audio program, with the listening volume adjusted to a comfortable level. | Behavioural | Brainwave Audio |
Primary outcome
Epworth Sleepiness Scale (ESS)
Time frame: All participants receive daily auditory stimulation for four weeks, with assessments at baseline, Week 2, and Week 4.
Daytime sleepiness is assessed using the Epworth Sleepiness Scale (ESS). Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. Changes are calculated by comparing post-intervention scores with baseline scores.
1 secondary outcome
Electroencephalography (EEG)
Time frame: All participants receive daily auditory stimulation for four weeks, with assessments at baseline, Week 2, and Week 4.
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 2 Nov 2026.
- Individual participant dataSharing planned: Undecided. A decision on sharing individual participant data has not yet been made. Any future sharing will be subject to participant consent, privacy protection, and applicable ethical and institutional requirements.
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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.
Yu-Tzu Chang, MD principal investigator
Kaohsiung Armed Forces General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brainwave Audio in people with Sleep Disturbances, run by Kaohsiung Armed Forces General 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 1 inclusion and 1 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 2 Nov 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?
Epworth Sleepiness Scale (ESS) (time frame: All participants receive daily auditory stimulation for four weeks, with assessments at baseline, Week 2, and Week 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.