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

NCT05339906 | Unknown

• 1 other identifier: ZOV01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stuttering, Adult; Stammering

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Heart Rate Variability meanRR [ms]

  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]

  The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after 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

• Heart Rate Variability RMSSD [ms]

  The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation

Study Arms (1)

ZOV.ai digital therapy candidate

EXPERIMENTAL

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

Interventions

ZOV.ai digital therapy candidate DEVICE

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

ZOV.ai digital therapy candidate

Eligibility Criteria

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

You may qualify if:

• Adults with stuttering (stammering) symptoms;

You may not qualify if:

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

Sponsors & Collaborators

• Oles Honchar Dnipro National University: lead
• SynthezAI Corp.: collaborator

Study Sites (1)

Oles Honchar Dnipro National University

Dnipro, Dnipropetrovska, 49010, Ukraine

RECRUITING

MeSH Terms

Conditions

Stuttering; Speech Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dmytro Lituiev, PhD

  SynthezAI Corp.

  STUDY CHAIR

Central Study Contacts

Dmytro V Chernetchenko, PhD

CONTACT

+380504208604; d.chernetchenko@zov.ai

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor

Model Details: Audio intervention with the same stimulus for participants with and without stuttering

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 21, 2022
• Study Start: May 25, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

UA (1)