Using taVNS to help breast cancer patients with insomnia
Investigating the Feasibility of Using TaVNS to Treat Insomnia in Individuals with Stage I-IV Breast Cancer
This study is testing if a new device that stimulates a nerve in the ear can help breast cancer patients with insomnia sleep better and feel less anxious and tired.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT06006299 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using transauricular Vagus Nerve Stimulation (taVNS) as a nonpharmacologic treatment for insomnia in patients with stage I-IV breast cancer. Participants will self-administer taVNS nightly at home, while study staff monitor for safety and tolerability. The study aims to evaluate the impact of taVNS on sleep quality, anxiety, and cancer-related fatigue over a one-week period. Data collected will also inform future product development for optimizing device designs.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18 and older diagnosed with stage I-IV breast cancer who experience insomnia.
Not a fit: Patients with severe mental illness, implanted medical devices, or those who are using daily sleep aids (except melatonin) may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safe and effective non-drug treatment option for insomnia in breast cancer patients.
How similar studies have performed: While the use of taVNS is a novel approach in this context, similar neuromodulation techniques have shown promise in treating insomnia in other populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 1 other locations
- UAB Lakeshore Collaborative (WHARF) — Birmingham, Alabama, United States (Recruiting)
- UAB Spain Rehabilitation Center — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Alexandra Evancho, DPT — The University of Alabama at Birmingham
- Study coordinator: Alexandra Evancho, DPT
- Email: amelgin@uab.edu
- Phone: (205)447-6846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.