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 (ZOV)

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.

Study Overview

• Status: Recruiting
• Conditions: Stuttering, Adult; Stammering
• Intervention / Treatment: Device: ZOV.ai digital therapy candidate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmytro V Chernetchenko, PhD; Phone Number: +380504208604; Email: d.chernetchenko@zov.ai

Study Locations

• Ukraine
  • Dnipropetrovska
    • Dnipro, Dnipropetrovska, Ukraine, 49010
      • Recruiting
      • Oles Honchar Dnipro National University
      • Contact: Dmytro Chernetchenko, PhD; Phone Number: +380504208604; Email: d.chernetchenko@zov.ai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults with stuttering (stammering) symptoms;

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZOV.ai digital therapy candidate; The arm will use 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. The total length of the audio stimuli is 5 minutes.	Device: ZOV.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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech disfluencies	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	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oles Honchar Dnipro National University
• Collaborators: SynthezAI Corp.
• Investigators: Study Chair: Dmytro Lituiev, PhD, SynthezAI Corp.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Stuttering; Auditory stimulation; Speech disorders; Binaural beats; Stammering
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stuttering
• Other Study ID Numbers: ZOV01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No