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Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)

NCT06006299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-02

No results posted yet for this study

Summary

In the present study, the investigators aim to investigate feasibility of utilizing noninvasive neuromodulation, specifically taVNS, as a nonpharmacologic approach to address insomnia in patients with stage I-IV breast cancer.

Conditions

Interventions

DEVICE

transauricular Vagus Nerve Stimulation

Transcutaneous auricular vagus nerve stimulation (taVNS) is a form of transcutaneous electrical nerve stimulation (TENS) applied to peripheral nerves, considered a low-risk procedure. It involves the use of standard neurostimulation electrodes placed on the surface of the external ear. The taVNS method delivers low-intensity, pulsed electrical currents with a peak current amplitude of \<4 mA, which is significantly lower than those used in most over-the-counter TENS devices for pain relief or muscle stimulation. By targeting the auricular branches of the vagus nerve, taVNS aims to stimulate specific neural pathways associated with various indications and intended uses. This non-invasive approach has broad applications in research, medical device treatments, health products, and cosmetic or lifestyle products.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Alexandra Evancho, DPT · The University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-26
Primary Completion
2025-07-09
Completion
2025-07-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT06006299 on ClinicalTrials.gov