Clinical trial NCT06006299: Investigating the Use of TaVNS to Treat Insomnia in Individuals with Breast Cancer (taVNS-insomnia-BC)
Official title: Investigating the Feasibility of Using TaVNS to Treat Insomnia in Individuals with Stage I-IV Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Insomnia
Keywords: taVNS
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All of the participants who are eligible will be in the taVNS group.
Primary purpose: TREATMENT

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 stage I-IV breast cancer.

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 events and severe adverse events as described to evaluate safety, tolerability, and biocompatibility. Additionally, investigators will estimate effect size by collecting outcome assessment data as described below. An additional objective is to use information gained through this study to inform product development activities. Specific information about the comfort, ease of use, and other user subject feedback will be used to inform future product development efforts for optimizing device designs.

Specific Aim 1: To evaluate the feasibility of using taVNS for patients with breast cancer to treat insomnia. HYPOTHESIS: Investigators expect that 40 patients with stage I-III breast cancer and insomnia will be enrolled and undergo taVNS to address insomnia, quantified by various sleep related outcome measures, with an estimated recruitment rate of 70%, eligibility rate of 70%, completion rate of 80%, and follow up rate of 80%.

Specific Aim 2: To evaluate the efficacy of repeated, nightly taVNS on sleep quality, anxiety, and cancer related fatigue. HYPOTHESIS: Investigators hypothesize that patients will report improved sleep, anxiety, depression, and cancer related fatigue after one week of taVNS.

Eligibility 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

Primary outcomes:
measure: Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.
timeFrame: 2 months
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: 2 months
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Assessment (Short Form)
timeFrame: 2 months
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: 2 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 2 months
measure: Cancer Fatigue Scale (CFS)
timeFrame: 2 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Lakeshore Collaborative (WHARF)
state: Alabama
city: Birmingham
country: United States
facility: UAB Spain Rehabilitation Center
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Alexandra Evancho, DPT
role: PRINCIPAL_INVESTIGATOR
References: