Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
taVNS
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.
干预措施: transauricular Vagus Nerve Stimulation (Device)
结局指标
主要结局
Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.
时间窗: 2 months
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.
次要结局
- Insomnia Severity Index(2 months)
- Patient Health Questionnaire-9 (PHQ-9)(2 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Assessment (Short Form)(2 months)
- Generalized Anxiety Disorder 7 (GAD-7)(2 months)
- The Pittsburgh Sleep Quality Index (PSQI)(2 months)
- Cancer Fatigue Scale (CFS)(2 months)
研究者
Alexandra Evancho
Assistant Professor
University of Alabama at Birmingham