Clinical trial · Interventional
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
NCT06006299CI-TRIAL-00115174completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| transauricular Vagus Nerve Stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- taVNS
- description
- 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.
- interventionNames
- Device: transauricular Vagus Nerve Stimulation
Primary outcomes (1)
- measure
- Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.
- timeFrame
- 2 months
- description
- 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.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDo 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