ClinicalTrials.gg
CompletedNCT06970444Updated May 14, 2025

taVNS Effect on Central Auditory Processing

An interventional study of transcutaneous auricular vagus nerve stimulation (taVNS) and Sham device in Central Auditory Disease, Auditory Processing Disorder, Central and Auditory Processing Disorders, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Medipol University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Apr 2023, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The behavioral effects of vagus nerve stimulation (VNS) and observed activation in the auditory cortex with transcutaneous auricular VNS (taVNS) raise questions about their potential impact on auditory processing. This study aims to investigate whether taVNS, which has not been studied in the context of central auditory processing (CAP), has any effects on CAP.

Read the detailed description

Experimental procedure First, the participants were made to sign the 'Informed Volunteer Consent Form'. Then, the MoCA test was applied, and pure tone audiometry test was performed on those who scored 21 or above and were determined to have normal cognitive abilities. After air and bone conduction pure tone thresholds were determined, speech reception thresholds with three-syllable phonetically balanced words and Speech Discrimination Scores (SDS) with monosyllabic phonetically balanced words were measured. Participants with normal hearing were included in the study. Central Auditory Processing (CAP) tests, Frequency Patterns Test (FPT) and Duration Patterns Test (DPT) were applied to the participants in the study group separately for each ear, and the current situation in the CAP evaluation was recorded. Then, taVNS was applied to left ear for 15 minutes with a biphasic, square stimulus with a pulse width of 250 µs, a stimulus at the sensor threshold level and a frequency of 20 Hz. The control group received sham stimulation with the stimulator closed and electrodes placed. After the stimulations, CAP tests were repeated for each ear separately. Differences between the study and control groups were examined. The application was performed in a dimly lit, sound-insulated double-walled cabin (a sound-insulated room in accordance with Industrial Acoustics 18 Company [IAC] standards), while sitting in a comfortable chair. The audio file was opened from the desktop computer and sent via the aux cable to the clinical audiometer device (AC40 Clinical Audiometer). The participant listened to the sound through supraaural headphones (TDH39).

70 healthy participants with 140 ears were included in the study. Participants were 18-40 years old. 40 people; 20 females (23,20±2,35 mean of years) were included in the study group with active taVNS and 30 people; 15 females (23,30±3,48 mean of years) were included in the control group. All participants were native Turkish speakers with normal cognitive conditions and hearing which has been demonstrated by routine tests. Further inclusion criteria were: age 18-40 years, normal CAP performance. The age range of the study was determined by taking into account that CAP skills decrease with increasing age. In order to eliminate heterogeneity, male-female balance was taken into account. As the effect of hemispheric lateralization, those with left hand dominance had differences in language skills and spatial attention, and in verbal and non-verbal behavioral tasks, compared to those with right hand dominance, only individuals with right hand dominance were included in the study, taking into account that it may affect the test results. Musical training is an important factor in FPT performance as it provides better frequency discrimination perception. Therefore, individuals with a professional music background were not included in the study, as it was thought that it could affect brain organization and cause differences in test results.

To evaluate cognitive functions, the MoCA test, was applied to the participants. Who scored 21 or above were determined to have normal cognitive abilities.

To confirm that the hearing abilities of the individuals participating in the study were normal, a pure tone and speech audiometry test and FPT-DPT test batteries were performed using the Interacoustic AC40 (Denmark) audiometer device. The hearing thresholds of octave band frequencies thresholds of 250 Hz to 8000 Hz were 25 dB or lower were considered normal.

FPT and DPT were applied to the participants, respectively. During or at the end of the tests, breaks were taken according to the participants' wishes so that they could focus.

FPT is a test battery developed to evaluate temporal sequencing ability, which is one of the subcategories of temporal processing. In our study, for FPT, an audio -mp3- file based on the parameters determined by Musiek was applied. The high frequency sound used as test stimulus frequencies was determined as 1122 Hz, and the low frequency sound was determined as 880 Hz. The length of the stimulus period was determined as 200 ms, and the inter-stimulus interval was 150 ms. There is a 10 ms rise-fall time between the stimuli. There were six possible combinations of tones (Low-Low-High (LLH), LHL, LHH, HLH, HLL and HHL). Participants were asked to verbally rank the sounds they heard according to their frequency and order of occurrence, and several stimulus sets were presented for trial purposes before the test, not to be included in the scoring. The test started when the participant indicated that she/he was ready. Stimuli were presented at 60 dB HL through TDH-39 over-ear headphones. Participants were presented with a total of 50 sets of stimuli, 25 triple stimuli for each ear, and FPT scores were calculated as a percentage for both ears separately.

It is a test set that measures another temporal sequencing skill known as DPT. In our study, sound recording for DPT was made using an audiometer in line with the criteria determined by Musiek. Stimuli were presented at a frequency of 1000 Hz. Long duration sounds were determined as 500 ms, and short duration sounds were determined as 250 ms. There was a 10 ms rise and fall time between stimuli. The interstimulus interval was set at 300 ms. There were six possible combinations of tones (Long-Long-Short (LLS), LSS, LSL, SLL, SSL, SLS). Participants were asked to verbally rank the sounds they heard according to their duration and the order in which they were presented, and stimulus sets were presented for trial purposes not to be included in the scoring. Before the test began, participants were asked to indicate their readiness. Stimuli were presented in a total of 50 sets, 25 triple stimuli for each ear, at 60 dB HL level, and separate DPT scores were calculated for both ears.

FPT and DPT allow participants to express some of the stimulus patterns presented to them in reverse. In the literature, 2 score types have been defined in which this situation is accepted as a right or wrong. In our study, scoring was done according to both score types.

These score types are listed below:

Rev Plus: Score type calculated by accepting the reversed patterns as correct that we mentioned as "Rev." in the tables.

Rev Minus: Score type calculated by accepting the reversed patterns as incorrect.

taVNS parameters After the first CAP evaluations of the participants in the study group, taVNS was applied via VAGUSTIM TENS (Vagustim Health Technologies, San Francisco, CA, USA) device. Stimulating electrodes were placed on the inner surface of the left ear between the tragus and concha (Figure2). Ultrasound gel was applied to the electrodes during placement to increase electrical conduction. Then, stimulation parameters adjusted and stimulation started. The stimulation amplitude increased gradually, with the guidance of the participants, at a comfortable level (sensory treshold level), where the stimulation was felt but did not cause pain or discomfort. Stimulation time was set as 15 minutes. Stimulation duration was limited to 15 minutes to prevent possible side effects like hypotension, dizziness, etc.

Stimulus parameters used when applying taVNS to the left ear: In the study of Peng et al., the stimulus parameters proven by f-MRI to create activity in the auditory cortex were taken as a reference. A biphasic modified square stimulus with a pulse width of 250 µs. Electric current amplitude threshold was adjusted according to participant tolerance. The stimulation frequency was kept at 20 Hz, which is known to activate nerve fibers.

02

Conditions studied

  • Central Auditory Disease
  • Auditory Processing Disorder, Central
  • Auditory Processing Disorders
  • Vagus Nerve Stimulation

Keywords

  • central auditory processing
  • transcutaneous auricular vagus nerve stimulation
  • central auditory processing disorder
  • aural rehabilitation
03

In context

Language Development Disorders

121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.

This study's enrollment of 70 is close to the median of 74 across 106 interventional studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being between 18-40 years old
  • Having a score of 21 or above on the test
  • Having a normal range on the bilateral pure tone audiometry test
  • Having no problems on any scanner
  • Having no professional music background
  • Having right hand dominance
  • Having no to T-a-VNS

Exclusion criteria

Exclusion Criteria:

  • Peripheral hearing disorders
  • Professional music history
  • Physical and emotional disorders that may affect the test results
  • Left-hand dominance
  • Persons in whom the use of T-a-VSU is
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    taVNS Group

    The group which recieved taVNS stimulation through their left ear

    Device: transcutaneous auricular vagus nerve stimulation (taVNS)

  • Sham comparator
    Sham (Placebo) g,Group

    control group received sham stimulation with the stimulator closed and electrodes placed in their left ear

    Other: Sham device

Interventions

  • Devicetranscutaneous auricular vagus nerve stimulation (taVNS)

    Transcutaneous auricular vagus nerve stimulation (taVNS) is an emerging non-invasive therapy that modulates brain activity by delivering electrical impulses to the auricular branch of the vagus nerve at the outer ear (Badran et al., 2018). taVNS subsequently stimulates the nucleus of tractus solitarius via the afferent vagus nerve fibers. The nucleus solitarius sends outputs to the hypothalamus, which is critical for sensory processing, including auditory processing, and also activates various brain regions, including the locus coeruleus, resulting in the release of neurotransmitters such as norepinephrine and serotonin, which are involved in neural plasticity and cognitive function, which is important for CAP. Another theory for taVNS effects is the release of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, which may further help to balance abnormal neural activity in auditory circuits.

  • OtherSham device

    the control group received sham stimulation with the stimulator closed and electrodes placed in their left ear

06

What researchers measure

Primary outcomes

  1. Frequency Patterns Test (FPT)

    FPT is a test battery developed to evaluate temporal sequencing ability, which is one of the subcategories of temporal processing. In our study, for FPT, an audio -mp3- file based on the parameters determined by Musiek was applied. The high frequency sound used as test stimulus frequencies was determined as 1122 Hz, and the low frequency sound was determined as 880 Hz. The length of the stimulus period was determined as 200 ms, and the inter-stimulus interval was 150 ms. There is a 10 ms rise-fall time between the stimuli. There were six possible combinations of tones (Low-Low-High (LLH), LHL, LHH, HLH, HLL and HHL). Participants were asked to verbally rank the sounds they heard according to their frequency and order of occurrence, and several stimulus sets were presented for trial purposes before the test, not to be included in the scoring.

    Time frame: Immediately before and after the stimulation (totally: 30 min)

  2. Duration Patterns Test (DPT)

    It is a test set that measures another temporal sequencing skill known as DPT (Musiek et al., 1990). In our study, sound recording for DPT was made using an audiometer in line with the criteria determined by Musiek. Stimuli were presented at a frequency of 1000 Hz. Long duration sounds were determined as 500 ms, and short duration sounds were determined as 250 ms. There was a 10 ms rise and fall time between stimuli. The interstimulus interval was set at 300 ms. There were six possible combinations of tones (Long-Long-Short (LLS), LSS, LSL, SLL, SSL, SLS). Participants were asked to verbally rank the sounds they heard according to their duration and the order in which they were presented, and stimulus sets were presented for trial purposes not to be included in the scoring. Before the test began, participants were asked to indicate their readiness. Stimuli were presented in a total of 50 sets, 25 triple stimuli for each ear, at 60 dB HL level, and separate DPT scores were calculated.

    Time frame: Immediately before and after the stimulation (totally: 30 min)

07

Study locations

1 site
  • Istanbul Medipol University
    Istanbul, Beykoz 34000, Turkey
08

References and documents

Publications

  • De Taeye L, Vonck K, van Bochove M, Boon P, Van Roost D, Mollet L, Meurs A, De Herdt V, Carrette E, Dauwe I, Gadeyne S, van Mierlo P, Verguts T, Raedt R. The P3 event-related potential is a biomarker for the efficacy of vagus nerve stimulation in patients with epilepsy. Neurotherapeutics. 2014 Jul;11(3):612-22. doi: 10.1007/s13311-014-0272-3. PubMed 24711167 ↗
  • Peng L, Mu K, Liu A, Zhou L, Gao Y, Shenoy IT, Mei Z, Chen Q. Transauricular vagus nerve stimulation at auricular acupoints Kindey (CO10), Yidan (CO11), Liver (CO12) and Shenmen (TF4) can induce auditory and limbic cortices activation measured by fMRI. Hear Res. 2018 Mar;359:1-12. doi: 10.1016/j.heares.2017.12.003. Epub 2017 Dec 24. PubMed 29305037 ↗
  • Musiek, F. E. (2002). The frequency pattern test: A guide. Hearing Journal, 55(6), 58. https://doi.org/10.1097/01.HJ.0000293280.99394.DD
  • Musiek FE. Frequency (pitch) and duration pattern tests. J Am Acad Audiol. 1994 Jul;5(4):265-8. PubMed 7949300 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2023 to primary completion in May 2024, 13 months.

Of 72 non-industry interventional studies with no phase under Language Development Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's 13 months is below that.

Counting every sponsor, half of 72 studies reached it within 30 months; a quarter within 19 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2025
First posted
May 14, 2025
StartActual
Apr 1, 2023
Primary completionActual
May 1, 2024
CompletionActual
Jul 19, 2024
Last update
May 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06970444
Lead sponsor
Medipol University
Responsible party
Ayberk Aydın Tunc (Audiologist, M.Sc., Medipol University) — Principal investigator
First posted
May 14, 2025
Start date
Apr 1, 2023
Primary completion
May 1, 2024
Completion
Jul 19, 2024
Last update
May 14, 2025

Study contacts

Ayberk Aydin Tunç, Master of Science
principal investigator · Istanbul Medipol University, Audiology Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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