Status:
COMPLETED
Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Breast Cancer
Insomnia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06006299
Start Date
September 26 2023
End Date
July 9 2025
Last Update
October 2 2025
Active Locations (2)
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1
UAB Lakeshore Collaborative (WHARF)
Birmingham, Alabama, United States, 35209
2
UAB Spain Rehabilitation Center
Birmingham, Alabama, United States, 35233