taVNS for Insomnia in Breast Cancer Patients
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byAlexandra Evancho, DPT
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Daily sleep aids
Disqualifiers: Severe mental illness, seizures, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
If you are using a daily sleep aid, except for melatonin, you will need to stop taking it to participate in the trial. However, using a sleep aid occasionally is allowed.
What data supports the effectiveness of this treatment for insomnia in breast cancer patients?
Research shows that transcutaneous auricular vagus nerve stimulation (taVNS) can significantly improve sleep quality, reduce fatigue, and alleviate symptoms like depression and anxiety in people with insomnia. This suggests it might also help breast cancer patients who struggle with sleep issues.
12345Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?
Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe for humans, with only mild and temporary side effects like ear pain, headache, and tingling. A large review found no serious adverse events linked to taVNS, making it a safe option for clinical use.
12346How does the treatment taVNS for insomnia in breast cancer patients differ from other treatments?
taVNS (transauricular Vagus Nerve Stimulation) is unique because it involves stimulating the vagus nerve through the ear, which is a non-invasive method, unlike many traditional treatments for insomnia that may involve medication or more invasive procedures.
7891011Eligibility Criteria
This trial is for adults over 18 with stage I-IV breast cancer who've had sleep problems like trouble falling or staying asleep at least three nights a week since their diagnosis. It's not for those with less than six months to live, implanted medical devices, certain nerve disorders, severe mental illness, cognitive impairment, regular sleep aid use (except melatonin), or a history of seizures.Inclusion Criteria
My sleep problems started or worsened after my cancer diagnosis.
I have trouble sleeping at least 3 nights a week for over 3 months.
I am 18 years old or older.
+2 more
Exclusion Criteria
I use sleep aids other than melatonin regularly.
I have had seizures in the past.
I have nerve damage, including issues with my jaw or facial paralysis.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants use the transauricular Vagus Nerve Stimulator nightly for 14 days, 15 minutes prior to sleeping
2 weeks
At-home self-administered
Follow-up
Participants are monitored for safety, tolerability, and effectiveness of the treatment
6 weeks
Data collection via surveys, interviews, and Fitbit wear
Outcome Assessment
Outcome measures such as PSQI, CFS, PHQ-9, ISI, PROMIS Anxiety, and GAD-7 are collected to evaluate sleep quality, anxiety, and fatigue
2 months
Participant Groups
The study tests taVNS—a non-drug method stimulating the ear's vagus nerve—to see if it helps improve sleep in breast cancer patients. Participants will receive this treatment and researchers will check if it's practical and effective for insomnia related to cancer.
1Treatment groups
Experimental Treatment
Group I: taVNSExperimental Treatment1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UAB Lakeshore Collaborative (WHARF)Birmingham, AL
UAB Spain Rehabilitation CenterBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
[Effect of transcutaneous auricular vagus nerve stimulation on nocturnal autonomic nervous function in primary insomnia patients]. [2022]To observe the effect of transcutaneous auricular vagus nerve stimulation (taVNS) on the sleep quality and nocturnal heart rate variability (HRV) in patients with primary insomnia.
Effect of Transcutaneous Vagus Nerve Stimulation at Auricular Concha for Insomnia: A Randomized Clinical Trial. [2020]Insomnia inflicts mental burden and decreases physical productivity and affects life quality. Transcutaneous vagus nerve stimulation (ta-VNS) may be an effective treatment option for insomnia. This study aims to evaluate the effect and safety of ta-VNS and compare it with transcutaneous nonvagus nerve stimulation (tn-VNS). A multicenter, randomized, clinical trial was conducted at 3 hospitals in China enrolling 72 insomnia participants from May 2016 to June 2017. Participants were randomly assigned (1 : 1) to receive 40 sessions of ta-VNS or tn-VNS treatment. 63 participants completed the trial. ta-VNS treatment significantly decreased the Pittsburgh Sleep Quality Index score, Epworth Sleepiness Scale score, Flinders Fatigue Scale score, Hamilton Depression Scale score, and Hamilton Anxiety Scale score over 4 weeks compared with those of the baseline. Moreover, it also significantly increased the 36-item Short-Form Health Survey Questionnaire scores compared with that of the baseline. However, it did not show significant differences compared with tn-VNS in changes of primary and secondary outcomes. The incidence of adverse events was low. ta-VNS significantly relieved insomnia over 4 weeks. Moreover, it also alleviated fatigue and improved participants' quality of life as well as other concomitant symptoms such as depression and anxiety. This trial is registered at Chinese Clinical Trial Registry (http://www.chictr.org.cn) with the registration number: ChiCTR-TRC-13003519.
Transcutaneous Auricular Vagus Nerve Stimulation Modulates the Prefrontal Cortex in Chronic Insomnia Patients: fMRI Study in the First Session. [2022]Transcutaneous auricular vagus nerve stimulation (taVNS) has been reported to be effective for chronic insomnia (CI). However, the appropriate population for taVNS to treat insomnia is unclear.
[Transcutaneous vagus nerve stimulation for primary insomnia and affective disorder:a report of 35 cases]. [2018]To observe and evaluate the clinical efficacy of transcutaneous vagus nerve stimulation (taVNS) at auricular concha for primary insomnia (PI) and affective disorder.
[Modulation of transcutaneous auricular vagus nerve stimulation on default mode network in patients with primary insomnia]. [2022]To explore the modulation of transcutaneous auricular vagus nerve stimulation (taVNS) on default mode network (DMN) in patients with primary insomnia (PI).
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet been investigated. This systematic review and meta-analysis on taVNS aimed to (1) systematically analyze study characteristics and AE assessment, (2) characterize and analyze possible AEs and their incidence, (3) search for predictable risk factors, (4) analyze the severity of AE, and (5) suggest an evidence-based taVNS adverse events questionnaire for safety monitoring. The articles searched were published through April 7, 2022, in Medline, Embase, Web of Science, Cochrane, and Lilacs databases. In general, we evaluated 177 studies that assessed 6322 subjects. From these, 55.37% of studies did not mention the presence or absence of any AEs; only 24.86% of the studies described that at least one adverse event occurred. In the 35 studies reporting the number of subjects with at least one adverse event, a meta-analytic approach to calculate the risk differences of developing an adverse event between active taVNS and controls was used. The meta-analytic overall adverse events incidence rate was calculated for the total number of adverse events reported on a 100,000 person-minutes-days scale. There were no differences in risk of developing an adverse event between active taVNS and controls. The incidence of AE, in general, was 12.84/100,000 person-minutes-days of stimulation, and the most frequently reported were ear pain, headache, and tingling. Almost half of the studies did not report the presence or absence of any AEs. We attribute this to the absence of AE in those studies. There was no causal relationship between taVNS and severe adverse events. This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical intervention.
Depression and ability to work after vestibular schwannoma surgery: a nationwide registry-based matched cohort study on antidepressants, sedatives, and sick leave. [2022]In patients with vestibular schwannomas (VS), tumor control is often achieved, and life expectancy is relatively good. The main risks of surgical treatment are hearing loss and facial nerve function. The occurrence of mood and sleeping disorders in relation to surgery is an important aspect of health that has rarely been studied. Similarly, only limited data exist on the rate of sick leave for patients with VS. In this nationwide registry-based study, we define the use of antidepressants and sedatives and the sick leave pattern before and after VS surgery.
Sex Differences in Vestibular Schwannoma. [2023]Vestibular schwannoma (VS) are equally common in men and woman. A number of epidemiological studies have reported on sex-specific aspects of incidence, tumor size, tinnitus and hearing loss. However, data on sex-specific, pre- and post-surgically quality of life (QoL) are rare. The objective of the present study was to determine sex-specific aspects on QoL in VS. Health-related QoL was analyzed in 260 patients (112 male/148 female) with unilateral sporadic VS using general (SF-36: general Short-Form Health Survey), disease-specific (PANQOL: Penn Acoustic Neuroma Quality-of-Life Scale, PANQOL) and symptom-specific (DHI: Dizziness Handicap Inventory; HHI: Hearing Handicap Inventory; THI: Tinnitus Handicap Inventory; FDI: Facial Disability Index) QoL questionnaires. Sex differences were evaluated pre- and postoperative by multi- and univariate analyses based on 200 preoperative and 88 postoperative questionnaires. Female patients were significantly more affected by dizziness, headaches, reduced energy and anxiety. Energy and balance changed similarly in both sexes after surgery. However, postoperative women tended to be more affected by facial palsy and headaches than men. Despite the greater physical impairment, general health improved equivalently or even more in female patients than in males. In conclusion, self-rated QoL in VS is significantly affected by sex and surgery. This should be taken into account when counseling VS patients regarding observation, radiotherapy, and surgery.
Decision analysis of treatment options for vestibular schwannoma. [2011]Widespread use of MR imaging has contributed to the more frequent diagnosis of vestibular schwannomas (VSs). These tumors represent 10% of primary adult intracranial neoplasms, and if they are symptomatic, they usually present with hearing loss and tinnitus. Currently, there are 3 treatment options for quality of life (QOL): wait and scan, microsurgery, and radiosurgery. In this paper, the authors' purpose is to determine which treatment modality yields the highest QOL at 5- and 10-year follow-up, considering the likelihood of recurrence and various complications.
Vestibular schwannomas in the modern era: epidemiology, treatment trends, and disparities in management. [2022]There are a variety of treatment options for the management of vestibular schwannomas (VSs), including microsurgical resection, radiotherapy, and observation. Although the choice of treatment is dependent on various patient factors, physician bias has been shown to significantly affect treatment choice for VS. In this study the authors describe the current epidemiology of VS and treatment trends in the US in the modern era. They also illustrate patient and tumor characteristics and elucidate their effect on tumor management.
Bevacizumab in neurofibromatosis type 2 (NF2) related vestibular schwannomas: a nationally coordinated approach to delivery and prospective evaluation. [2022]NF2 patients develop multiple nervous system tumors including bilateral vestibular schwannomas (VS). The tumors and their surgical treatment are associated with deafness, neurological disability, and mortality.Medical treatment with bevacizumab has been reported to reduce VS growth and to improve hearing. In addition to evaluating these effects, this study also aimed to determine other important consequences of treatment including patient-reported quality of life and the impact of treatment on surgical VS rates.