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

NCT06006299 | Completed FDA Device

• 2 other identifiers: IRB-300010460PREP grant
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Breast Cancer; Insomnia

Keywords

taVNS

Outcome Measures

Primary Outcomes (1)

• Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.

  Our mixed method approach for evaluating feasibility includes measuring eligibility rates, retention rates, refusal rates, and follow-up rates as well as analyzing information gathered from interviews. In this feasibility study, a recruitment rate of at least 70% within 6 weeks, an eligibility rate of \>70%, a completion rate of 80% of the protocol, and a follow up rate of 80% will be considered successful.

  2 months

Secondary Outcomes (6)

• Insomnia Severity Index

  2 months

• The Pittsburgh Sleep Quality Index (PSQI)

  2 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Assessment (Short Form)

  2 months

• Generalized Anxiety Disorder 7 (GAD-7)

  2 months

• Patient Health Questionnaire-9 (PHQ-9)

  2 months

Study Arms (1)

taVNS

EXPERIMENTAL

Participants will use the transauricular Vagus Nerve Stimulator provided to them by the lab for 14 days, 15 minutes prior to sleeping. Data will be collected via surveys, interviews, and Fitbit wear over the course of 2 months. A sleep diary will be kept to record sleep quality.

Device: transauricular Vagus Nerve Stimulation

Interventions

transauricular Vagus Nerve Stimulation DEVICE

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.

taVNS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age
• diagnosed stage I-IV breast cancer
• self-reported difficulty falling asleep, staying asleep, or waking up too early, for at least three nights per week for a duration of at least three months
• beginning or worsening of sleep disturbance since cancer diagnosis (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?)
• English-speaking

You may not qualify if:

• Are using a daily sleep aid except melatonin (use of a sleep aid as needed will be permitted, and use will be noted).
• have a history of severe mental illness
• have an implanted medical device of any type
• have a history of seizures
• have peripheral neuropathy including temporal mandibular disorders and Bells Palsy
• have vasovagal syncope
• have moderate to severe cognitive impairment
• have \<6 months to live as determined by the physician

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (2)

UAB Lakeshore Collaborative (WHARF)

Birmingham, Alabama, 35209, United States

Location

UAB Spain Rehabilitation Center

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• Do M, Evancho A, Tyler WJ. Bilateral transcutaneous auricular vagus nerve stimulation for the treatment of insomnia in breast cancer. Sci Rep. 2025 Dec 4;16(1):1081. doi: 10.1038/s41598-025-30600-6.

  PMID: 41345210 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Alexandra Evancho, DPT

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All of the participants who are eligible will be in the taVNS group.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 23, 2023
• Study Start: September 26, 2023
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)