Poor Sleep QualityNCT07440264
Theta Brainwave Entrainment Combined With Natural Sound on Healthcare Shift Workers With Poor Sleep Quality: A Randomized Controlled Trial
A study testing Theta brainwave entrainment combined with natural sound in people with Poor Sleep Quality, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
Brief summary The goal of this clinical trial is to investigate the effects of theta BWE combined with natural sounds on sleep quality in healthcare shift workers. The main questions it aims to answer are: Does theta brainwave entrainment (BWE) in combination with natural sound improve the sleep quality based on the… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Poor Sleep Quality
- What is being tested?
- Theta brainwave entrainment combined with natural sound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Oct 2025to 9 Feb 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- healthcare shift workers at Universitas Hasanuddin Hospital, Makassar, Indonesia.
- healthcare shift workers for at least the past three months,
- aged 20-50 years,
- having poor sleep quality based on the Pittsburgh Sleep Quality Index (PSQI) (>5),
- willing to participate in the entire study and sign an informed consent
Who cannot join
- having hearing impairment,
- currently taking psychotropic medications that affect sleep patterns,
- having a history of epilepsy, head trauma, or other brain disorders
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Hasanuddin Hospital
Makassar, South Sulawesi, 90245
About this study
Brief summary
The goal of this clinical trial is to investigate the effects of theta BWE combined with natural sounds on sleep quality in healthcare shift workers. The main questions it aims to answer are:
Read more
- Does theta brainwave entrainment (BWE) in combination with natural sound improve the sleep quality based on the Pittsburgh Sleep Quality Index (PSQI) score?
- Does theta BWE in combination with natural sound change theta power based on quantitative electroencephalography (qEEG)?
Researchers will compare theta BWE combined with natural sound to a BWE audio at a sham frequency to see if theta BWE improves sleep quality.
Participants will:
- undergo baseline assessments, including the PSQI questionnaire and a quantitative Electroencephalography (qEEG), before intervention is given.
- receive theta BWE binaural beats (intervention group) or BWE audio at a sham frequency (control group) for 20-30 minutes daily for 14 days.
- be re-measured on the PSQI questionnaire and qEEG assessment after the intervention period.
- Conditions
- Poor Sleep Quality
- Being tested
- Theta brainwave entrainment combined with natural sound, BWE audio at a sham frequency
- Keywords
- poor sleep quality, sleep disturbance, PSQI, theta brainwave, brainwave entrainment, healthcare shift workers, qEEg, natural sound
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta brainwave entrainment combined with natural soundOther
Also called Theta brainwave entrainment based on binaural beats, Theta binaural beats, The Theta BWE-based binaural-beat auditory stimulation
The Theta BWE-based binaural-beat auditory stimulation intervention will be implemented according to the following protocol. Participants in the intervention group will receive BWE audio through stereo headphones at two frequencies: binaural beats at 6 Hz (theta) and natural sounds. Sessions will be conducted for 20-30 minutes daily, in a quiet room. The intervention will consist of 14 sessions over two weeks. Researchers will ensure the audio volume is at a safe and comfortable level and record participants' daily compliance. During the intervention period, researchers will monitor respondents periodically to ensure adherence to the intervention protocol and to identify any side effects or complaints. Monitoring will be conducted using a daily checklist, and compliance records will be analyzed as part of the evaluation of the intervention's implementation success.
BWE audio at a sham frequencyOther
The control group participants will listen to the BWE audio through stereo headphones at a sham frequency. Sessions will be conducted for 20-30 minutes daily, in a quiet room. The intervention will consist of 14 sessions over two weeks. Researchers will ensure the audio volume is at a safe and comfortable level and record participants' daily compliance. During the intervention period, researchers will monitor respondents periodically to ensure adherence to the intervention protocol and to identify any side effects or complaints. Monitoring will be conducted using a daily checklist, and compliance records will be analyzed as part of the evaluation of the intervention's implementation success.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Theta BWE combined with natural sound Receives: Other: Theta brainwave entrainment combined with natural sound |
| Control group | Sham comparator | BWE audio at a sham frequency Receives: Other: BWE audio at a sham frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI) score
The PSQI score will be used to assess participants' overall sleep quality. PSQI is a self-rated questionnaire comprising 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A PSQI score of more than five indicates poor sleep quality.
Measured: Baseline (enrollment) and at 2 weeks post-intervention
Secondary outcomes (1)
Theta power
Theta power is operationally defined as spectral power within the 4-8 Hz frequency range, quantified as absolute and relative theta power derived from FFT analysis of uantitative Electroencephalography (qEEG) recordings. Researchers will perform a qEEG examination using the international 10-20 system and install 19-32 electrodes on the scalp using electrodes in a lying position, record for 15 minutes with the eyes closed or open, and perform qEEG extraction to obtain the Fast Fourier Transform (FFT) theta absolute and relative power values. The measurements will be conducted before and after the intervention period.
Measured: Baseline (enrollment) and at 2 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Oct 2025
- Primary completion23 Jan 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Sleep QualityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rezki Indriyanti, Hasanuddin University
- Investigators
- Abdul Muis, dr., Sp.S(K), Study chair, Department of Neurology, Faculty of Medicine, Universitas Hasanuddin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440264
- Sponsor's protocol ID
- UH25100814
- Other IDs
- 834/UN4.6.4.5.31/PP26/2025
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta Brainwave Entrainment Combined With Natural Sound on Healthcare Shift Workers With Poor Sleep Quality: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07440264
- Acronym / sponsor ID
- UH25100814
- Conditions
- Poor Sleep Quality
- Keywords
- poor sleep quality, sleep disturbance, PSQI, theta brainwave, brainwave entrainment, healthcare shift workers, qEEg, natural sound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 27 Feb 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.
Brief summary
The goal of this clinical trial is to investigate the effects of theta BWE combined with natural sounds on sleep quality in healthcare shift workers. The main questions it aims to answer are:
- Does theta brainwave entrainment (BWE) in combination with natural sound improve the sleep quality based on the Pittsburgh Sleep Quality Index (PSQI) score?
- Does theta BWE in combination with natural sound change theta power based on quantitative electroencephalography (qEEG)?
Researchers will compare theta BWE combined with natural sound to a BWE audio at a sham frequency to see if theta BWE improves sleep quality.
Participants will:
- undergo baseline assessments, including the PSQI questionnaire and a quantitative Electroencephalography (qEEG), before intervention is given.
- receive theta BWE binaural beats (intervention group) or BWE audio at a sham frequency (control group) for 20-30 minutes daily for 14 days.
- be re-measured on the PSQI questionnaire and qEEG assessment after the intervention period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Theta brainwave entrainment combined with natural soundTheta BWE combined with natural sound |
| Control group | Sham comparator | Other: BWE audio at a sham frequencyBWE audio at a sham frequency |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthcare shift workers at Universitas Hasanuddin Hospital, Makassar, Indonesia.
- healthcare shift workers for at least the past three months,
- aged 20-50 years,
- having poor sleep quality based on the Pittsburgh Sleep Quality Index (PSQI) (>5),
- willing to participate in the entire study and sign an informed consent
Key exclusion criteria (3 listed)
- having hearing impairment,
- currently taking psychotropic medications that affect sleep patterns,
- having a history of epilepsy, head trauma, or other brain disorders
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 |
|---|---|---|
| Theta brainwave entrainment combined with natural soundAlso: Theta brainwave entrainment based on binaural beats, Theta binaural beats, The Theta BWE-based binaural-beat auditory stimulationThe Theta BWE-based binaural-beat auditory stimulation intervention will be implemented according to the following protocol. Participants in the intervention group will receive BWE audio through stereo headphones at two frequencies: binaural beats at 6 Hz (theta) and natural sounds. Sessions will be conducted for 20-30 minutes daily, in a quiet room. The intervention will consist of 14 sessions over two weeks. Researchers will ensure the audio volume is at a safe and comfortable level and record participants' daily compliance. During the intervention period, researchers will monitor respondents periodically to ensure adherence to the intervention protocol and to identify any side effects or complaints. Monitoring will be conducted using a daily checklist, and compliance records will be analyzed as part of the evaluation of the intervention's implementation success. | Other | Intervention group |
| BWE audio at a sham frequencyThe control group participants will listen to the BWE audio through stereo headphones at a sham frequency. Sessions will be conducted for 20-30 minutes daily, in a quiet room. The intervention will consist of 14 sessions over two weeks. Researchers will ensure the audio volume is at a safe and comfortable level and record participants' daily compliance. During the intervention period, researchers will monitor respondents periodically to ensure adherence to the intervention protocol and to identify any side effects or complaints. Monitoring will be conducted using a daily checklist, and compliance records will be analyzed as part of the evaluation of the intervention's implementation success. | Other | Control group |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: Baseline (enrollment) and at 2 weeks post-intervention
The PSQI score will be used to assess participants' overall sleep quality. PSQI is a self-rated questionnaire comprising 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A PSQI score of more than five indicates poor sleep quality.
1 secondary outcome
Theta power
Time frame: Baseline (enrollment) and at 2 weeks post-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 27 Feb 2026.
- Individual participant dataSharing planned: No. The data that support the findings of this study will be available upon reasonable request.
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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.
Abdul Muis, dr., Sp.S(K) study chair
Department of Neurology, Faculty of Medicine, Universitas Hasanuddin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta brainwave entrainment combined with natural sound in people with Poor Sleep Quality, run by Hasanuddin University at 1 site in Indonesia.
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 3 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 27 Feb 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
Pittsburgh Sleep Quality Index (PSQI) score (time frame: Baseline (enrollment) and at 2 weeks post-intervention). 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 27 Feb 2026.