An interventional study of ZOV.ai digital therapy candidate in Stuttering, Adult and Stammering, sponsored by Oles Honchar Dnipro National University. Status unknown at 1 site in Ukraine. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Oles Honchar Dnipro National University · Not applicable, Interventional, and Basic science
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.
74 studies on the registry are indexed under Stuttering; 23 are open to participants now.
This study's planned enrollment of 25 is below the median of 44 across 57 interventional studies indexed under Stuttering.
Browse Stuttering studies →This is the only study on the registry with Oles Honchar Dnipro National University as lead sponsor.
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Exclusion Criteria:
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
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
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
Time frame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Heart Rate Variability Stress Index [a.u.]
Stress Level changes assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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