40-Hz Audiovisual Stimulation in Schizophrenia Spectrum Disorders

NCT07782034 | Completed

• 1 other identifier: 40-Hz in Patients with Schizop
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and within 2 days after completion of the 12-week intervention

Study Arms (2)

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.

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.

Other: Sham group

Interventions

40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic Stimulation OTHER

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.

BBM and RPS group

Sham group OTHER

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.

Sham group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Current participation in a day-care program, community rehabilitation center, or rehabilitation ward.

You may not qualify if:

• Acute illness episode or unstable physical condition.
• History of epilepsy or risk of seizures.
• Substance abuse.
• Impaired or disturbed consciousness.

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

Asia Univeraity

Taichung, WuFeng, 41354, Taiwan

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: February 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)