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NCT Number: NCT07802301

taVNS in Infants 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants ≥37 weeks post-menstrual age
  • Diagnosed with dysphagia and significant sucking/swallowing impairment
  • Limited oral feeding ability
  • Admitted to NICU

Exclusion criteria

  • Cardiomyopathy
  • Unstable bradycardia
  • Significant respiratory support requirement
  • Absence of gag reflex
  • Inability to manage secretions
  • Infants of poorly controlled diabetic mothers

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Number of bradycardia events during intervention

    Time frame: During each intervention session throughout the 3-week intervention period

    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.

  2. Number of oxygen desaturation events during intervention

    Time frame: During each intervention session throughout the 3-week intervention period

    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.

  3. Number of coughing or choking episodes during intervention

    Time frame: During each intervention session throughout the 3-week intervention period

    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.

  4. Intervention completion rate

    Time frame: End of the 3-week intervention period

    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.

  5. Protocol adherence rate

    Time frame: Throughout the 3-week intervention period

    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.

  6. Oromotor treatment tolerance measured by adverse event rate per session

    Time frame: During each 30-minute intervention session throughout the 3-week intervention period

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Doe Jenkins, MD

CONTACT

[email protected]

8433642662

Heather C McGhee, PhD

CONTACT

[email protected]

7708834902

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Zabara Foundation

Registry information

Official study title

Novel Pairing of taVNS and an Oral Sensorimotor Protocol in Infants With Severe Dysphagia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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