RECRUITING

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

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Conditions

Breast CancerInsomniataVNS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigating the Feasibility of Using TaVNS to Treat Insomnia in Individuals with Stage I-IV Breast Cancer

Quick Facts

Study Start:2023-09-26
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06006299

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. at least 18 years of age
  2. 2. diagnosed stage I-IV breast cancer
  3. 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. 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. 5. English-speaking
  1. 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. 2. have a history of severe mental illness
  3. 3. have an implanted medical device of any type
  4. 4. have a history of seizures
  5. 5. have peripheral neuropathy including temporal mandibular disorders and Bells Palsy
  6. 6. have vasovagal syncope
  7. 7. have moderate to severe cognitive impairment
  8. 8. have \<6 months to live as determined by the physician

Contacts and Locations

Study Contact

Alexandra Evancho, DPT
CONTACT
(205)447-6846
amelgin@uab.edu
Wendy Reed, PhD
CONTACT
wend@uab.edu

Principal Investigator

Alexandra Evancho, DPT
PRINCIPAL_INVESTIGATOR
The University of Alabama at Birmingham

Study Locations (Sites)

UAB Lakeshore Collaborative (WHARF)
Birmingham, Alabama, 35209
United States
UAB Spain Rehabilitation Center
Birmingham, Alabama, 35233
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Alexandra Evancho, DPT, PRINCIPAL_INVESTIGATOR, The University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-26
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-09-26
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • taVNS

Additional Relevant MeSH Terms

  • Breast Cancer
  • Insomnia