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taVNS in Infants Severe Dysphagia

ConditionsDysphagiaSwallowing DisordersFeeding and Eating Disorders of Infancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants ≥37 weeks post-menstrual age

Diagnosed with dysphagia and significant sucking/swallowing impairment

Limited oral feeding ability

Admitted to NICU

Disqualifiers

Cardiomyopathy

Unstable bradycardia

Significant respiratory support requirement

Absence of gag reflex

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 Protocol

    Behavioral

    A structured oromotor stimulation protocol including stimulation of lips, tongue, cheeks, and palate, along with non-nutritive sucking and feeding practice as appropriate.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: taVNS Paired Oromotor TrainingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Zabara Foundation

Collaborator

Source ClinicalTrials.gov

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