Clinical trial NCT05339906: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stuttering, Adult
Stammering
Keywords: Speech disorders
Binaural beats
Auditory stimulation
Stuttering
Stammering
Lead sponsor: Oles Honchar Dnipro National University
Sponsor class: OTHER
Collaborators: name: SynthezAI Corp.
First posted: 2022-04-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Audio intervention with the same stimulus for participants with and without stuttering
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Adults with stuttering (stammering) symptoms;

Exclusion Criteria:

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

Primary outcomes:
measure: Speech disfluencies
timeFrame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Secondary outcomes:
measure: Heart Rate Variability Stress Index [a.u.]
timeFrame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
measure: Heart Rate Variability meanRR [ms]
timeFrame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
measure: Heart Rate Variability Total Power [ms^2]
timeFrame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
measure: Heart Rate Variability SDNN [ms]
timeFrame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
measure: Heart Rate Variability RMSSD [ms]
timeFrame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
measure: EEG spectral power in beta frequency range, [uV^2]
timeFrame: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation
Other outcomes:
Locations:
city: Dnipro
country: Ukraine
facility: Oles Honchar Dnipro National University
state: Dnipropetrovska
Study officials:
affiliation: SynthezAI Corp.
name: Dmytro Lituiev, PhD
role: STUDY_CHAIR
References: