An interventional study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Oral Sensorimotor Training Protocol in Dysphagia, Swallowing Disorders and Feeding and Eating Disorders of Infancy, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
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Exclusion Criteria:
Infants will receive transcutaneous auricular vagus nerve stimulation (taVNS) paired with an oral sensorimotor training protocol twice daily for 15 days over three weeks.
Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) · Behavioral: Oral Sensorimotor Training Protocol
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.
A structured oromotor stimulation protocol including stimulation of lips, tongue, cheeks, and palate, along with non-nutritive sucking and feeding practice as appropriate.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment baseline and post-treatment, following completion of the 3-week intervention period
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During each 30-minute intervention session throughout the 3-week intervention period
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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