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

NCT ID: NCT05339906

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2022-12-31

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.

Conditions

Stuttering, Adult; Stammering

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ZOV.ai digital therapy candidate

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults with stuttering (stammering) symptoms;

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SynthezAI Corp.

UNKNOWN

Sponsor Role: collaborator

Oles Honchar Dnipro National University

OTHER

Sponsor Role: lead

Responsible Party

Dmytro Chernetchenko

PhD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dmytro Lituiev, PhD

Role: STUDY_CHAIR

SynthezAI Corp.

Locations

Oles Honchar Dnipro National University

Dnipro, Dnipropetrovska, Ukraine

Site Status: RECRUITING

Countries

Ukraine

Central Contacts

Dmytro V Chernetchenko, PhD

Role: CONTACT

d.chernetchenko@zov.ai

+380504208604

Facility Contacts

Dmytro Chernetchenko, PhD

Role: primary

d.chernetchenko@zov.ai

+380504208604

Other Identifiers

ZOV01

Identifier Type: -

Identifier Source: org_study_id