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| Name | Class |
|---|---|
| SynthezAI Corp. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZOV.ai digital therapy candidate | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZOV.ai digital therapy candidate | 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 |
| 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 |
| 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] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmytro V Chernetchenko, PhD | Contact | +380504208604 | d.chernetchenko@zov.ai |
| Name | Affiliation | Role |
|---|---|---|
| Dmytro Lituiev, PhD | SynthezAI Corp. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oles Honchar Dnipro National University | Recruiting | Dnipro | Dnipropetrovska | 49010 | Ukraine |
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Audio intervention with the same stimulus for participants with and without stuttering
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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 |
| ID | Term |
|---|---|
| D013342 | Stuttering |
| D013064 | Speech Disorders |
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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