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

Stuttering, Adult Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339906
• Other study ID #: ZOV01
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Oles Honchar Dnipro National University
• Contact: Dmytro V Chernetchenko, PhD
• Phone: +380504208604
• Email: d.chernetchenko[@]zov.ai
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with stuttering (stammering) symptoms;

Exclusion Criteria:

• Hearing disabilities;

• Applying other drugs or devices simultaneously;

Related Conditions & MeSH terms

• Stammering
• Stuttering
• Stuttering, Adult

Intervention

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

Locations

Country	Name	City	State
Ukraine	Oles Honchar Dnipro National University	Dnipro	Dnipropetrovska

Sponsors (2)

Lead Sponsor	Collaborator
Oles Honchar Dnipro National University	SynthezAI Corp.

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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