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

Completed · Phase 1

Conditions studied: Breast Cancer, Insomnia

In brief

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.

Key facts

Study ID

NCT06006299

Run by

University of Alabama at Birmingham

People needed

20

Starts

2023-09-26

Expected to finish

2025-07-09

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• have moderate to severe cognitive impairment
• have <6 months to live as determined by the physician

Where it is running

• UAB Lakeshore Collaborative (WHARF) — Birmingham, Alabama, United States
• UAB Spain Rehabilitation Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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