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Trial Title:
Investigating the Use of TaVNS to Treat Insomnia in Individuals with Breast Cancer (taVNS-insomnia-BC)
NCT ID:
NCT06006299
Condition:
Breast Cancer
Insomnia
Conditions: Official terms:
Breast Neoplasms
Sleep Initiation and Maintenance Disorders
Conditions: Keywords:
taVNS
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
All of the participants who are eligible will be in the taVNS group.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
transauricular Vagus Nerve Stimulation
Description:
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.
Arm group label:
taVNS
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. at least 18 years of age
2. diagnosed stage I-IV breast cancer
3. 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
4. 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?)
5. English-speaking
Exclusion Criteria:
1. Are using a daily sleep aid except melatonin (use of a sleep aid as needed will be
permitted, and use will be noted).
2. have a history of severe mental illness
3. have an implanted medical device of any type
4. have a history of seizures
5. have peripheral neuropathy including temporal mandibular disorders and Bells Palsy
6. have vasovagal syncope
7. have moderate to severe cognitive impairment
8. have <6 months to live as determined by the physician
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UAB Lakeshore Collaborative (WHARF)
Address:
City:
Birmingham
Zip:
35209
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexandra Evancho, DPT
Phone:
(205)447-6846
Email:
amelgin@uab.edu
Facility:
Name:
UAB Spain Rehabilitation Center
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexandra Evancho, DPT
Phone:
(205)447-6846
Email:
amelgin@uab.edu
Start date:
September 26, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University of Alabama at Birmingham
Agency class:
Other
Source:
University of Alabama at Birmingham
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06006299
