DysphagiaNCT07802301
taVNS in Infants Severe Dysphagia
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Oral Sensorimotor Training Protocol in people with Dysphagia and Swallowing Disorders, run by Medical University of South Carolina.
Trial summary
This study evaluates the safety, feasibility, and preliminary effects of transcutaneous auricular vagus nerve stimulation (taVNS) paired with an oral sensorimotor training protocol in infants with severe dysphagia. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Dysphagia, Swallowing Disorders, Feeding and Eating Disorders of Infancy
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Oral Sensorimotor Training Protocol
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants ≥37 weeks post-menstrual age
- Diagnosed with dysphagia and significant sucking/swallowing impairment
- Limited oral feeding ability
- Admitted to NICU
Who cannot join
- Cardiomyopathy
- Unstable bradycardia
- Significant respiratory support requirement
- Absence of gag reflex
- Inability to manage secretions
- Infants of poorly controlled diabetic mothers
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Novel Pairing of taVNS and an Oral Sensorimotor Protocol in Infants With Severe Dysphagia
This study evaluates the safety, feasibility, and preliminary effects of transcutaneous auricular vagus nerve stimulation (taVNS) paired with an oral sensorimotor training protocol in infants with severe dysphagia. Infants with significant sucking and swallowing impairment will receive twice-daily taVNS paired with oromotor training over a three-week period. Outcomes include swallowing mechanics, sucking proficiency, and functional feeding performance assessed before and after the intervention.
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Oral Sensorimotor Training Protocol
- Keywords
- Transcutaneous Auricular Vagus Nerve Stimulation, Oromotor Training, Dysphagia, Feeding Disorders
- Medical subject headings
- Deglutition Disorders, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device
A non-invasive neuromodulation intervention delivered via electrodes placed on the ear tragus. Electrical stimulation is delivered at low intensity during feeding-related oromotor training sessions.
Oral Sensorimotor Training ProtocolBehavioural
A structured oromotor stimulation protocol including stimulation of lips, tongue, cheeks, and palate, along with non-nutritive sucking and feeding practice as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| taVNS Paired Oromotor Training | Experimental | Infants will receive transcutaneous auricular vagus nerve stimulation (taVNS) paired with an oral sensorimotor training protocol twice daily for 15 days over three weeks. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Behavioral: Oral Sensorimotor Training Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in swallowing impairment as measured by the BaByVFSImP
Swallowing mechanics will be assessed using the Baby Videofluoroscopic Swallow Study Impairment Profile, a standardized scoring tool used to evaluate physiologic components of infant swallowing during videofluoroscopic swallow study. Scores will be compared from pre-treatment to post-treatment to determine change in swallowing impairment. Lower scores indicate less impairment.
Measured: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
Change in airway protection as measured by the Penetration-Aspiration Scale
Airway protection during swallowing will be assessed using the Penetration-Aspiration Scale from videofluoroscopic swallow study recordings. Scores describe the depth of airway invasion and the infant's response to material entering the airway. Scores will be compared from pre-treatment to post-treatment. Lower scores indicate better airway protection.
Measured: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
Change in early feeding skills as measured by the Early Feeding Skills Assessment
Feeding skills will be assessed using the Early Feeding Skills Assessment, a standardized clinical assessment used to evaluate infant feeding readiness, oral feeding skills, physiologic stability, and feeding tolerance. Scores will be compared from pre-treatment to post-treatment to evaluate change in functional feeding performance. Higher scores indicate more mature or more effective feeding skills.
Measured: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
Change in sucking pressures
Sucking pressures will be measured. Values will be compared from pre-treatment to post-treatment to evaluate change in sucking mechanics.
Measured: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
Change in oral feeding volume
Oral feeding volume will be measured as the amount of prescribed feeding volume taken orally. Oral intake volume will be compared from pre-treatment to post-treatment to determine change in functional oral feeding ability. Greater oral intake volume indicates improved feeding performance.
Measured: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
Secondary outcomes (6)
Number of bradycardia events during intervention
Safety will be assessed by recording the number of bradycardia events occurring during intervention sessions. Bradycardia will be defined as heart rate less than 80 beats per minute for 5 seconds or longer during a feed. Events will be recorded per feeding session.
Measured: During each intervention session throughout the 3-week intervention period
Number of oxygen desaturation events during intervention
Safety will be assessed by recording the number of oxygen desaturation events occurring during intervention sessions. Oxygen desaturation will be defined as oxygen saturation less than 80% for 5 seconds or longer during a feed. Events will be recorded per feeding session.
Measured: During each intervention session throughout the 3-week intervention period
Number of coughing or choking episodes during intervention
Safety will be assessed by recording the number of coughing or choking episodes occurring during intervention sessions. Events will be recorded per feeding session to monitor clinical signs of feeding intolerance or airway compromise.
Measured: During each intervention session throughout the 3-week intervention period
Intervention completion rate
Feasibility will be assessed by determining the number and percentage of enrolled infants who complete the full 3-week paired taVNS and oromotor training intervention. Completion will be defined as finishing the planned intervention period.
Measured: End of the 3-week intervention period
Protocol adherence rate
Feasibility will be assessed by recording the number and percentage of planned oromotor training sessions completed. Protocol adherence will be calculated as the number of completed sessions divided by the number of planned sessions.
Measured: Throughout the 3-week intervention period
Oromotor treatment tolerance measured by adverse event rate per session
Treatment tolerance will be assessed using an events-to-time ratio, calculated as the number of bradycardia and/or oxygen desaturation events occurring during each 30-minute oromotor training session. A lower event rate indicates better treatment tolerance.
Measured: During each 30-minute intervention session throughout the 3-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start30 Aug 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Zabara Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802301
- Sponsor's protocol ID
- Pro00150100
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Pairing of taVNS and an Oral Sensorimotor Protocol in Infants With Severe Dysphagia
- ClinicalTrials.gov ID
- NCT07802301
- Acronym / sponsor ID
- Pro00150100
- Keywords
- Transcutaneous Auricular Vagus Nerve Stimulation, Oromotor Training, Dysphagia, Feeding Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Zabara Foundation
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 3 Sep 2026 (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.
This study evaluates the safety, feasibility, and preliminary effects of transcutaneous auricular vagus nerve stimulation (taVNS) paired with an oral sensorimotor training protocol in infants with severe dysphagia. Infants with significant sucking and swallowing impairment will receive twice-daily taVNS paired with oromotor training over a three-week period. Outcomes include swallowing mechanics, sucking proficiency, and functional feeding performance assessed before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| taVNS Paired Oromotor Training | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Behavioral: Oral Sensorimotor Training ProtocolInfants will receive transcutaneous auricular vagus nerve stimulation (taVNS) paired with an oral sensorimotor training protocol twice daily for 15 days over three weeks. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants ≥37 weeks post-menstrual age
- Diagnosed with dysphagia and significant sucking/swallowing impairment
- Limited oral feeding ability
- Admitted to NICU
Key exclusion criteria (6 listed)
- Cardiomyopathy
- Unstable bradycardia
- Significant respiratory support requirement
- Absence of gag reflex
- Inability to manage secretions
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 |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)A non-invasive neuromodulation intervention delivered via electrodes placed on the ear tragus. Electrical stimulation is delivered at low intensity during feeding-related oromotor training sessions. | Device | taVNS Paired Oromotor Training |
| Oral Sensorimotor Training ProtocolA structured oromotor stimulation protocol including stimulation of lips, tongue, cheeks, and palate, along with non-nutritive sucking and feeding practice as appropriate. | Behavioural | taVNS Paired Oromotor Training |
Primary outcome
Change in swallowing impairment as measured by the BaByVFSImP
Time frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
Swallowing mechanics will be assessed using the Baby Videofluoroscopic Swallow Study Impairment Profile, a standardized scoring tool used to evaluate physiologic components of infant swallowing during videofluoroscopic swallow study. Scores will be compared from pre-treatment to post-treatment to determine change in swallowing impairment. Lower scores indicate less impairment.
Change in airway protection as measured by the Penetration-Aspiration Scale
Time frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
Airway protection during swallowing will be assessed using the Penetration-Aspiration Scale from videofluoroscopic swallow study recordings. Scores describe the depth of airway invasion and the infant's response to material entering the airway. Scores will be compared from pre-treatment to post-treatment. Lower scores indicate better airway protection.
Change in early feeding skills as measured by the Early Feeding Skills Assessment
Time frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
Feeding skills will be assessed using the Early Feeding Skills Assessment, a standardized clinical assessment used to evaluate infant feeding readiness, oral feeding skills, physiologic stability, and feeding tolerance. Scores will be compared from pre-treatment to post-treatment to evaluate change in functional feeding performance. Higher scores indicate more mature or more effective feeding skills.
Change in sucking pressures
Time frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
Sucking pressures will be measured. Values will be compared from pre-treatment to post-treatment to evaluate change in sucking mechanics.
Change in oral feeding volume
Time frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
Oral feeding volume will be measured as the amount of prescribed feeding volume taken orally. Oral intake volume will be compared from pre-treatment to post-treatment to determine change in functional oral feeding ability. Greater oral intake volume indicates improved feeding performance.
6 secondary outcomes
Number of bradycardia events during intervention
Time frame: During each intervention session throughout the 3-week intervention period
Number of oxygen desaturation events during intervention
Time frame: During each intervention session throughout the 3-week intervention period
Number of coughing or choking episodes during intervention
Time frame: During each intervention session throughout the 3-week intervention period
Intervention completion rate
Time frame: End of the 3-week intervention period
Protocol adherence rate
Time frame: Throughout the 3-week intervention period
Oromotor treatment tolerance measured by adverse event rate per session
Time frame: During each 30-minute intervention session throughout the 3-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Oral Sensorimotor Training Protocol in people with Dysphagia and Swallowing Disorders, run by Medical University of South Carolina.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather C McGhee, PhD (7708834902, mcghee@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in swallowing impairment as measured by the BaByVFSImP (time frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period). The study lists 5 primary outcomes in all. 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 3 Sep 2026.