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

Not Applicable

• Conditions: Stuttering, Adult; Stammering
• Interventions: Device: ZOV.ai digital therapy candidate

• Registration Number: NCT05339906
• Lead Sponsor: Oles Honchar Dnipro National University

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.

Study Timeline

• Study Start: 2021-05-25
• Study First Submitted: 2022-03-31
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-15
• Last Update Submitted: 2022-04-15
• Study First Posted: 2022-04-21
• Last Update Posted: 2022-04-21
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Adults with stuttering (stammering) symptoms;

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZOV.ai digital therapy candidate	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.

Primary Outcome Measures

Name	Time	Method
Speech disfluencies	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	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

Name	Time	Method
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	Stress Level changes assessed by ECG HRV measurements before, just after and 10 minutes after auditory 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	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]	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	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]	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	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]	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	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]	The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation	Electrical spectral density in beta frequency range of brain activity measured before, just after and 10 minutes after auditory stimulation

Trial Locations

Locations (1)

Oles Honchar Dnipro National University; 🇺🇦 Dnipro, Dnipropetrovska, Ukraine