Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomni… (NCT06006299) | Clinical Trial Compass
CompletedPhase 1
Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)
United States20 participantsStarted 2023-09-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was a Phase 1 study focused on whether taVNS — a device that stimulates a nerve through the ear — was feasible to use for insomnia in breast cancer patients, not yet whether it actually works; given that it was only testing feasibility, what do we actually know so far about whether this approach is safe and effective enough to consider?
2Since the trial has already completed recruitment, is there any published data or results from this study that you've seen, and would those findings change how you'd approach my insomnia treatment?
3taVNS is a non-drug approach to treating insomnia — how does it compare to the standard options you'd typically recommend for insomnia in someone at my stage of breast cancer treatment?
4Insomnia is really common during breast cancer treatment — are there proven, guideline-recommended treatments like cognitive behavioral therapy for insomnia (CBT-I) that I should be trying first, rather than waiting to see if an experimental approach like taVNS becomes more widely available?
5If this Phase 1 trial showed taVNS was feasible, is there a follow-up Phase 2 or Phase 3 trial I might be eligible to discuss with you that would give me access to this approach while contributing to more definitive research on whether it actually helps?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.