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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)

Primary Purpose

Stuttering, Adult, Stammering

Status
Recruiting
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
ZOV.ai digital therapy candidate
Sponsored by
Oles Honchar Dnipro National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stuttering, Adult focused on measuring Speech disorders, Binaural beats, Auditory stimulation, Stuttering, Stammering

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults with stuttering (stammering) symptoms;

Exclusion Criteria:

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

Sites / Locations

  • Oles Honchar Dnipro National UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ZOV.ai digital therapy candidate

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Heart Rate Variability Stress Index [a.u.]
Stress Level changes assessed by ECG HRV measurements before, just after and 10 minutes after auditory 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
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
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
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
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

Full Information

First Posted
March 31, 2022
Last Updated
April 15, 2022
Sponsor
Oles Honchar Dnipro National University
Collaborators
SynthezAI Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT05339906
Brief Title
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
Acronym
ZOV
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oles Honchar Dnipro National University
Collaborators
SynthezAI Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Adult, Stammering
Keywords
Speech disorders, Binaural beats, Auditory stimulation, Stuttering, Stammering

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Audio intervention with the same stimulus for participants with and without stuttering
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ZOV.ai digital therapy candidate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ZOV.ai digital therapy candidate
Intervention Description
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
Primary Outcome Measure Information:
Title
Speech disfluencies
Description
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
Time Frame
The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Secondary Outcome Measure Information:
Title
Heart Rate Variability Stress Index [a.u.]
Description
Stress Level changes assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
Time Frame
The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Title
Heart Rate Variability meanRR [ms]
Description
Average of RR-intervals array assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
Time Frame
The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Title
Heart Rate Variability Total Power [ms^2]
Description
Total Power of RR-intervals array spectrogram assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
Time Frame
The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Title
Heart Rate Variability SDNN [ms]
Description
SDNN value of RR-intervals array assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
Time Frame
The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Title
Heart Rate Variability RMSSD [ms]
Description
RMSSD value of RR-intervals array assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
Time Frame
The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Title
EEG spectral power in beta frequency range, [uV^2]
Description
Electrical spectral density in beta frequency range of brain activity measured before, just after and 10 minutes after auditory stimulation
Time Frame
The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults with stuttering (stammering) symptoms; Exclusion Criteria: Hearing disabilities; Applying other drugs or devices simultaneously;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmytro V Chernetchenko, PhD
Phone
+380504208604
Email
d.chernetchenko@zov.ai
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmytro Lituiev, PhD
Organizational Affiliation
SynthezAI Corp.
Official's Role
Study Chair
Facility Information:
Facility Name
Oles Honchar Dnipro National University
City
Dnipro
State/Province
Dnipropetrovska
ZIP/Postal Code
49010
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmytro Chernetchenko, PhD
Phone
+380504208604
Email
d.chernetchenko@zov.ai

12. IPD Sharing Statement

Learn more about this trial

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

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