Stuttering, AdultZOVNCT05339906
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
A study testing ZOV.ai digital therapy candidate in people with Stuttering, Adult and Stammering, run by Oles Honchar Dnipro National University at 1 site in Ukraine.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stuttering, Adult, Stammering
- What is being tested?
- ZOV.ai digital therapy candidate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUkraine
- Study dates
- 25 May 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with stuttering (stammering) symptoms;
Who cannot join
- Hearing disabilities;
- Applying other drugs or devices simultaneously;
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
Oles Honchar Dnipro National University
Dnipro, Dnipropetrovska, 49010
Dmytro Chernetchenko, PhD, +380504208604, d.chernetchenko@zov.ai
About this study
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.
Read the 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.
- Conditions
- Stuttering, Adult, Stammering
- Being tested
- ZOV.ai digital therapy candidate
- Keywords
- Speech disorders, Binaural beats, Auditory stimulation, Stuttering, Stammering
- Medical subject headings
- Stuttering, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOV.ai digital therapy candidateDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ZOV.ai digital therapy candidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Secondary outcomes (6)
Heart Rate Variability Stress Index [a.u.]
Stress Level changes assessed by ECG HRV measurements before, just after and 10 minutes after auditory stimulation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start25 May 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stuttering, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Audio intervention with the same stimulus for participants with and without stuttering
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oles Honchar Dnipro National University
- Sponsor type
- University, hospital or other
- Collaborators
- SynthezAI Corp.
- Responsible party
- Principal investigator, Dmytro Chernetchenko, Oles Honchar Dnipro National University
- Investigators
- Dmytro Lituiev, PhD, Study chair, SynthezAI Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339906
- Sponsor's protocol ID
- ZOV01
- Acronym
- ZOV
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05339906
- Acronym / sponsor ID
- ZOV / ZOV01
- Conditions
- Stuttering, Adult, Stammering
- Keywords
- Speech disorders, Binaural beats, Auditory stimulation, Stuttering, Stammering
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Oles Honchar Dnipro National UniversityUniversity, hospital or other
- Collaborators
- SynthezAI Corp.
- Study start
- 25 May 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Audio intervention with the same stimulus for participants with and without stuttering
| Arm | Type | Receives |
|---|---|---|
| ZOV.ai digital therapy candidate | Experimental | Device: ZOV.ai digital therapy candidateThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with stuttering (stammering) symptoms;
Key exclusion criteria (2 listed)
- Hearing disabilities;
- Applying other drugs or devices simultaneously;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZOV.ai digital therapy candidateZOV.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 | Device | ZOV.ai digital therapy candidate |
Primary outcome
Speech disfluencies
Time frame: 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
6 secondary outcomes
Heart Rate Variability Stress Index [a.u.]
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]
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]
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]
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]
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]
Time frame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmytro Lituiev, PhD study chair
SynthezAI Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZOV.ai digital therapy candidate in people with Stuttering, Adult and Stammering, run by Oles Honchar Dnipro National University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmytro V Chernetchenko, PhD (+380504208604, d.chernetchenko@zov.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech disfluencies (time frame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.