Study of the Effect of the Auditory Stimulation on Stuttering Symptoms in Patients With a Deficit of Spectral Power in the EEG Beta Frequency Band

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05339906

Acronym

ZOV

Enrollment

Registered

2022-04-21

Start date

2021-05-25

Completion date

2022-12-31

Last updated

2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stammering, Stuttering, Adult

Keywords

Speech disorders, Binaural beats, Auditory stimulation, Stuttering, Stammering

Brief summary

In this study, the investigators will research the efficacy of a novel auditory neuro modulating technology that leverages euphonic music tracks with broad-spectrum binaural beats to induce selective EEG spectral power changes.

Detailed description

Stuttering is a speech disorder that affects more than 70 million people worldwide, limiting their ability to communicate and socialize. During recent decades, several studies have demonstrated a link between stuttering and a deficit of β EEG spectral power. In this study, the investigators will research the efficacy of a novel auditory neuro modulating technology that leverages euphonic music tracks with broad-spectrum binaural beats to induce selective EEG spectral power changes. Participants are adults with stuttering and without speech disfluencies from the control group will expose to euphonic binaural stimuli for 5 minutes. The brain electrical activity patterns (EEG) and ECG bio-signals will record prior to, during, and after exposure.

Interventions

DEVICEZOV.ai digital therapy candidate

ZOV.ai is a novel auditory neuro modulating technology that leverages euphonic music tracks with broad-spectrum binaural beats to induce selective EEG spectral power changes to improve stuttering symptoms

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Audio intervention with the same stimulus for participants with and without stuttering

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Adults with stuttering (stammering) symptoms;

Exclusion criteria

* Hearing disabilities; * Applying other drugs or devices simultaneously;

Design outcomes

Primary

Measure	Time frame	Description
Speech disfluencies	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	The total number of repetitions, blocks and prolongations during the speech (assessed by speech therapist) measured before, just after and 10 minutes after auditory stimulation

Secondary

Measure	Time frame	Description
Heart Rate Variability meanRR [ms]	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	Average of RR-intervals array assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
Heart Rate Variability Total Power [ms^2]	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	Total Power of RR-intervals array spectrogram assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
Heart Rate Variability Stress Index [a.u.]	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	Stress Level changes assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
Heart Rate Variability RMSSD [ms]	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	RMSSD value of RR-intervals array assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
EEG spectral power in beta frequency range, [uV^2]	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	Electrical spectral density in beta frequency range of brain activity measured before, just after and 10 minutes after auditory stimulation
Heart Rate Variability SDNN [ms]	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	SDNN value of RR-intervals array assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation

Countries

Ukraine

Contacts

Primary ContactDmytro V Chernetchenko, PhD

d.chernetchenko@zov.ai+380504208604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026