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taVNS in Infants Severe Dysphagia

NCT07802301 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-09-03

No results posted yet for this study

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. 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.

Conditions

  • Dysphagia
  • Swallowing Disorders
  • Feeding and Eating Disorders of Infancy

Interventions

DEVICE

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.

BEHAVIORAL

Oral Sensorimotor Training Protocol

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-30
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Device
Yes

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802301 on ClinicalTrials.gov