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 Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stuttering, Adult, Stammering

Intervention / Treatment
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* Device: ZOV.ai digital therapy candidate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with stuttering (stammering) symptoms; Exclusion Criteria: Hearing disabilities; Applying other drugs or devices simultaneously;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Audio intervention with the same stimulus for participants with and without stuttering
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZOV.ai digital therapy candidate<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Speech disorders, Binaural beats, Auditory stimulation, Stuttering, Stammering