AnxietyNCT07782034
40-Hz Audiovisual Stimulation in Schizophrenia Spectrum Disorders
A study testing 40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic Stimulation in people with Anxiety, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
This randomized, sham-controlled trial evaluated the effects of 40-Hz binaural beat music (BBM) combined with 40-Hz rhythmic photic stimulation (RPS) in adults with schizophrenia spectrum disorders. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- 40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2024to 30 Jul 2024
- 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
- Diagnosis of schizophrenia or schizoaffective disorder according to DSM-5 criteria, made by a board-certified psychiatrist at least 1 year prior to enrollment.
- Age 20 to 60 years.
- Stable psychiatric symptoms, with no adjustment of major psychotropic medications for at least 2 consecutive months.
- No severe hearing impairment.
- 4. Current participation in a day-care program, community rehabilitation center, or rehabilitation ward.
Who cannot join
- Acute illness episode or unstable physical condition.
- History of epilepsy or risk of seizures.
- Substance abuse.
- Impaired or disturbed consciousness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 40-Hz Binaural Beat Music Combined With Rhythmic Photic Stimulation on Psychological Distress, Anxiety, Cognitive Function, and Electroencephalographic Spectral Activity in Patients With Schizophrenia Spectrum Disorders: A Sham-Controlled Randomized Trial
This randomized, sham-controlled trial evaluated the effects of 40-Hz binaural beat music (BBM) combined with 40-Hz rhythmic photic stimulation (RPS) in adults with schizophrenia spectrum disorders. A total of 55 participants with schizophrenia or schizoaffective disorder were randomly assigned to either the BBM plus RPS group or a sham control group. Participants received 20-minute sessions three times per week for 12 consecutive weeks, for a total of 36 sessions. The primary outcome was anxiety measured using the Beck Anxiety Inventory (BAI). Secondary outcomes included psychological distress measured using the Five-item Brief Symptom Rating Scale (BSRS-5) and global cognitive function measured using the Mini-Mental State Examination (MMSE). Electroencephalographic (EEG) relative power across delta, theta, alpha, beta, and gamma frequency bands was also assessed as an exploratory physiological outcome.
- Conditions
- Anxiety
- Being tested
- 40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic Stimulation, Sham group
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic StimulationOther
Participants received simultaneous 40-Hz binaural beat music (BBM) and 40-Hz rhythmic photic stimulation (RPS). The BBM was generated using 200-Hz and 240-Hz carrier tones to produce a 40-Hz binaural beat and was embedded in relaxing music delivered through circumaural stereo headphones at 60-65 dB SPL. The RPS was delivered through glasses equipped with bilateral white LEDs producing a 40-Hz square-wave flicker with a 50% duty cycle and an illuminance of 400 lx. Participants received the combined auditory and visual stimulation for 20 minutes per session with their eyes closed, three times per week for 12 consecutive weeks, for a total of 36 sessions.
Sham groupOther
Participants in the sham group underwent the same session procedures as the intervention group but did not receive 40-Hz binaural beat stimulation or rhythmic photic stimulation. Participants wore circumaural stereo headphones and RPS glasses and listened to the same relaxing music for 20 minutes; however, the music contained no binaural beats, and the light-output module of the RPS glasses remained switched off so that no flickering light was delivered. The glasses were powered on with the power indicator illuminated to maintain a similar device appearance. Music tracks, sound volume, session duration, and environmental conditions were identical to those of the intervention group. Sessions were administered three times per week for 12 consecutive weeks, for a total of 36 sessions.
| Study group | Role | What they receive |
|---|---|---|
| BBM and RPS group | Experimental | Participants assigned to the BBM and RPS group received combined 40-Hz binaural beat music (BBM) and 40-Hz rhythmic photic stimulation (RPS). During each session, participants wore circumaural stereo headphones and RPS glasses and received 20 minutes of relaxing music embedded with 40-Hz binaural beats while simultaneously receiving 40-Hz rhythmic photic stimulation with their eyes closed. The binaural beats were generated using 200-Hz and 240-Hz carrier tones and delivered at 60-65 dB SPL. The RPS glasses delivered bilateral white LED stimulation at 40 Hz using a square-wave pattern with a 50% duty cycle and an illuminance of 400 lx. Sessions were administered three times per week for 12 consecutive weeks, for a total of 36 sessions. Receives: Other: 40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic Stimulation |
| Sham group | Placebo comparator | Participants assigned to the sham group underwent the same session procedures as the intervention group. During each session, participants wore circumaural stereo headphones and RPS glasses and listened to the same relaxing music for 20 minutes with their eyes closed. However, the music contained no binaural beats, and the light-output module of the RPS glasses was switched off so that no rhythmic photic stimulation was delivered. To maintain a similar device appearance, the RPS glasses were powered on with the power indicator illuminated. Music tracks, sound volume, session duration, and other environmental conditions were identical to those of the intervention group. Sessions were administered three times per week for 12 consecutive weeks, for a total of 36 sessions. Receives: Other: Sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Severity as Measured by the Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) is a 21-item self-report measure used to assess the severity of anxiety symptoms. Each item is rated from 0 to 3, yielding a total score ranging from 0 to 63, with higher scores indicating greater anxiety severity. The primary outcome was the change in total BAI score from baseline to post-intervention.
Measured: Baseline and within 2 days after completion of the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Feb 2024
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Shang-Yu, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782034
- Sponsor's protocol ID
- 40-Hz in Patients with Schizop
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 40-Hz Binaural Beat Music Combined With Rhythmic Photic Stimulation on Psychological Distress, Anxiety, Cognitive Function, and Electroencephalographic Spectral Activity in Patients With Schizophrenia Spectrum Disorders: A Sham-Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT07782034
- Acronym / sponsor ID
- 40-Hz in Patients with Schizop
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 24 Aug 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 randomized, sham-controlled trial evaluated the effects of 40-Hz binaural beat music (BBM) combined with 40-Hz rhythmic photic stimulation (RPS) in adults with schizophrenia spectrum disorders. A total of 55 participants with schizophrenia or schizoaffective disorder were randomly assigned to either the BBM plus RPS group or a sham control group. Participants received 20-minute sessions three times per week for 12 consecutive weeks, for a total of 36 sessions. The primary outcome was anxiety measured using the Beck Anxiety Inventory (BAI). Secondary outcomes included psychological distress measured using the Five-item Brief Symptom Rating Scale (BSRS-5) and global cognitive function measured using the Mini-Mental State Examination (MMSE). Electroencephalographic (EEG) relative power across delta, theta, alpha, beta, and gamma frequency bands was also assessed as an exploratory physiological outcome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBM and RPS group | Experimental | Other: 40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic StimulationParticipants assigned to the BBM and RPS group received combined 40-Hz binaural beat music (BBM) and 40-Hz rhythmic photic stimulation (RPS). During each session, participants wore circumaural stereo headphones and RPS glasses and received 20 minutes of relaxing music embedded with 40-Hz binaural beats while simultaneously receiving 40-Hz rhythmic photic stimulation with their eyes closed. The binaural beats were generated using 200-Hz and 240-Hz carrier tones and delivered at 60-65 dB SPL. The RPS glasses delivered bilateral white LED stimulation at 40 Hz using a square-wave pattern with a 50% duty cycle and an illuminance of 400 lx. Sessions were administered three times per week for 12 consecutive weeks, for a total of 36 sessions. |
| Sham group | Placebo comparator | Other: Sham groupParticipants assigned to the sham group underwent the same session procedures as the intervention group. During each session, participants wore circumaural stereo headphones and RPS glasses and listened to the same relaxing music for 20 minutes with their eyes closed. However, the music contained no binaural beats, and the light-output module of the RPS glasses was switched off so that no rhythmic photic stimulation was delivered. To maintain a similar device appearance, the RPS glasses were powered on with the power indicator illuminated. Music tracks, sound volume, session duration, and other environmental conditions were identical to those of the intervention group. Sessions were administered three times per week for 12 consecutive weeks, for a total of 36 sessions. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of schizophrenia or schizoaffective disorder according to DSM-5 criteria, made by a board-certified psychiatrist at least 1 year prior to enrollment.
- Age 20 to 60 years.
- Stable psychiatric symptoms, with no adjustment of major psychotropic medications for at least 2 consecutive months.
- No severe hearing impairment.
- 4. Current participation in a day-care program, community rehabilitation center, or rehabilitation ward.
Key exclusion criteria (4 listed)
- Acute illness episode or unstable physical condition.
- History of epilepsy or risk of seizures.
- Substance abuse.
- Impaired or disturbed consciousness.
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 |
|---|---|---|
| 40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic StimulationParticipants received simultaneous 40-Hz binaural beat music (BBM) and 40-Hz rhythmic photic stimulation (RPS). The BBM was generated using 200-Hz and 240-Hz carrier tones to produce a 40-Hz binaural beat and was embedded in relaxing music delivered through circumaural stereo headphones at 60-65 dB SPL. The RPS was delivered through glasses equipped with bilateral white LEDs producing a 40-Hz square-wave flicker with a 50% duty cycle and an illuminance of 400 lx. Participants received the combined auditory and visual stimulation for 20 minutes per session with their eyes closed, three times per week for 12 consecutive weeks, for a total of 36 sessions. | Other | BBM and RPS group |
| Sham groupParticipants in the sham group underwent the same session procedures as the intervention group but did not receive 40-Hz binaural beat stimulation or rhythmic photic stimulation. Participants wore circumaural stereo headphones and RPS glasses and listened to the same relaxing music for 20 minutes; however, the music contained no binaural beats, and the light-output module of the RPS glasses remained switched off so that no flickering light was delivered. The glasses were powered on with the power indicator illuminated to maintain a similar device appearance. Music tracks, sound volume, session duration, and environmental conditions were identical to those of the intervention group. Sessions were administered three times per week for 12 consecutive weeks, for a total of 36 sessions. | Other | Sham group |
Primary outcome
Change in Anxiety Severity as Measured by the Beck Anxiety Inventory (BAI)
Time frame: Baseline and within 2 days after completion of the 12-week intervention
The Beck Anxiety Inventory (BAI) is a 21-item self-report measure used to assess the severity of anxiety symptoms. Each item is rated from 0 to 3, yielding a total score ranging from 0 to 63, with higher scores indicating greater anxiety severity. The primary outcome was the change in total BAI score from baseline to 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 24 Aug 2026.
- Individual participant dataSharing planned: No
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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 40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic Stimulation in people with Anxiety, run by National Cheng Kung University 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 4 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 24 Aug 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. 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?
Change in Anxiety Severity as Measured by the Beck Anxiety Inventory (BAI) (time frame: Baseline and within 2 days after completion of the 12-week 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 24 Aug 2026.