NCT06006299

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

Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will evaluate the feasibility, safety, and tolerability of nightly, at-home self-administered taVNS treatments. Study staff will monitor for adverse reactions, unanticipated adverse device events and severe adverse events as described to evaluate safety, tolerability, and biocompatibility. Additionally, investigators will estimate effect size by collecting outcome assessment data as described below. An additional objective is to use information gained through this study to inform product development activities. Specific information about the comfort, ease of use, and other user subject feedback will be used to inform future product development efforts for optimizing device designs. Specific Aim 1: To evaluate the feasibility of using taVNS for patients with breast cancer to treat insomnia. HYPOTHESIS: Investigators expect that 40 patients with stage I-III breast cancer and insomnia will be enrolled and undergo taVNS to address insomnia, quantified by various sleep related outcome measures, with an estimated recruitment rate of 70%, eligibility rate of 70%, completion rate of 80%, and follow up rate of 80%. Specific Aim 2: To evaluate the efficacy of repeated, nightly taVNS on sleep quality, anxiety, and cancer related fatigue. HYPOTHESIS: Investigators hypothesize that patients will report improved sleep, anxiety, depression, and cancer related fatigue after one week of taVNS.

Conditions

• Breast Cancer
• Insomnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-26
• Primary completion: 2025-07-09
• Completion: 2025-07-09
• First posted: 2023-08-23
• Last updated: 2025-10-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study