An interventional study of 40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic Stimulation and Sham group in Anxiety, sponsored by National Cheng Kung University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by National Cheng Kung University · Not applicable, Interventional, and Supportive care
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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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 55 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →National Cheng Kung University is the lead sponsor of 63 studies on the registry; 12 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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4. Current participation in a day-care program, community rehabilitation center, or rehabilitation ward.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic Stimulation
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.
Other: Sham group
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.
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.
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.
Time frame: Baseline and within 2 days after completion of the 12-week intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in Jun 2024, 4 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 4 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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