taVNS for Insomnia in Breast Cancer Patients

Recruiting at 1 trial location

Overseen By Wendy Reed, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Daily sleep aids

Disqualifiers: Severe mental illness, seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

40 Participants Needed

What You Need to Know Before You Apply

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.

Is 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. ^{1 2 3 4 5}

How 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. ^{6 7 8 9 10}

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. ^{1 2 3 4 11}

Who Is on the Research Team?

Alexandra Evancho, DPT

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 have been diagnosed with breast cancer at any stage.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• transauricular Vagus Nerve Stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: taVNS Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improved sleep quality and structure in 21 patients with primary insomnia over a 4-week treatment period, as measured by the Pittsburgh Sleep Quality Index and various sleep metrics.

The treatment led to increased sleep efficiency and deeper sleep stages, along with enhanced nocturnal heart rate variability, suggesting that taVNS may help regulate autonomic nervous system functions related to sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of transcutaneous auricular vagus nerve stimulation on nocturnal autonomic nervous function in primary insomnia patients]. Zhao, YN., Li, SY., Li, SX., et al.[2022]

Transcutaneous vagus nerve stimulation (ta-VNS) significantly improved sleep quality and reduced symptoms of fatigue, depression, and anxiety in 63 insomnia participants over 4 weeks, as measured by various scales including the Pittsburgh Sleep Quality Index.

While ta-VNS showed positive effects on insomnia and overall quality of life, it did not demonstrate significant differences in outcomes compared to transcutaneous nonvagus nerve stimulation (tn-VNS), indicating that both treatments may have similar efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Transcutaneous Vagus Nerve Stimulation at Auricular Concha for Insomnia: A Randomized Clinical Trial. Jiao, Y., Guo, X., Luo, M., et al.[2020]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improved sleep quality and reduced fatigue in patients with chronic insomnia, as evidenced by decreased scores on the Pittsburgh Sleep Quality Index and Flinders Fatigue Scale after 4 weeks of treatment.

The treatment appeared to modulate activity in the left dorsolateral prefrontal cortex, suggesting that the initial state of this brain region may predict how effective taVNS will be for individuals with chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Modulates the Prefrontal Cortex in Chronic Insomnia Patients: fMRI Study in the First Session. He, JK., Jia, BH., Wang, Y., et al.[2022]

Transcutaneous vagus nerve stimulation (taVNS) applied at the auricular concha significantly improved sleep quality, depression, and anxiety symptoms in 35 patients with primary insomnia over a treatment period of 4 weeks.

The treatment was found to be safe, with no adverse reactions reported, suggesting that taVNS could be a beneficial long-term intervention for managing primary insomnia and associated affective disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcutaneous vagus nerve stimulation for primary insomnia and affective disorder:a report of 35 cases]. Luo, M., Qu, X., Li, S., et al.[2018]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improved sleep quality in patients with primary insomnia, as indicated by a lower Pittsburgh sleep quality index (PSQI) score after 4 weeks of treatment.

taVNS altered the functional connectivity in the brain's default mode network (DMN), particularly between the posterior cingulate cortex and other brain regions, suggesting a potential mechanism for its effectiveness in treating insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Modulation of transcutaneous auricular vagus nerve stimulation on default mode network in patients with primary insomnia]. Zhang, S., He, JK., Zhao, YN., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

In a study of 333 patients with vestibular schwannomas, the use of antidepressants and sedatives did not significantly differ between patients and matched controls before and after surgery, indicating similar mental health management.

However, two years after surgery, a higher percentage of patients (75%) had no registered sick leave compared to controls (88%), suggesting that patients may face more challenges in returning to work post-surgery, particularly if they experienced new neurological deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression and ability to work after vestibular schwannoma surgery: a nationwide registry-based matched cohort study on antidepressants, sedatives, and sick leave. Thurin, E., Förander, P., Bartek, J., et al.[2022]

In a study of 260 patients with vestibular schwannoma, it was found that female patients reported significantly worse quality of life related to dizziness, headaches, and anxiety both before and after surgery compared to male patients.

Despite experiencing greater physical impairments, female patients showed similar or even greater improvements in general health after surgery, highlighting the need for sex-specific considerations in treatment and counseling for vestibular schwannoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex Differences in Vestibular Schwannoma. Machetanz, K., Wang, SS., Oberle, L., et al.[2023]

Radiosurgery provides a significantly better quality of life (QOL) at 5 years compared to microsurgery and the wait-and-scan approach for patients with vestibular schwannomas, with QOL scores of 0.97, 0.953, and 0.898 respectively.

Complications from wait-and-scan and microsurgery negatively affect patient quality of life more than those from radiosurgery, although 10-year follow-up data is limited and further studies are needed to confirm long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision analysis of treatment options for vestibular schwannoma. Whitmore, RG., Urban, C., Church, E., et al.[2011]

The incidence of vestibular schwannomas (VSs) in the US is 1.2 per 100,000 people per year, with surgery being the most common treatment option, used in nearly half of the cases studied (49.04%).

Older age and racial disparities significantly influence treatment choices, as older patients are less likely to undergo surgery, and African American patients are less likely to receive surgical treatment despite having larger tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular schwannomas in the modern era: epidemiology, treatment trends, and disparities in management. Babu, R., Sharma, R., Bagley, JH., et al.[2022]

In a study of 61 NF2 patients treated with bevacizumab over a median follow-up of 23 months, 39% showed partial tumor response and 51% had stabilization of tumor growth, indicating the drug's efficacy in managing vestibular schwannomas.

Bevacizumab treatment also led to improved hearing in 86% of patients and enhanced quality of life, while reducing the need for surgical interventions, although some patients experienced hypertension and proteinuria as side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab in neurofibromatosis type 2 (NF2) related vestibular schwannomas: a nationally coordinated approach to delivery and prospective evaluation. Morris, KA., Golding, JF., Axon, PR., et al.[2022]

Citations

1. China pubmed.ncbi.nlm.nih.gov

[Effect of transcutaneous auricular vagus nerve stimulation on nocturnal autonomic nervous function in primary insomnia patients]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Transcutaneous Vagus Nerve Stimulation at Auricular Concha for Insomnia: A Randomized Clinical Trial. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Modulates the Prefrontal Cortex in Chronic Insomnia Patients: fMRI Study in the First Session. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Transcutaneous vagus nerve stimulation for primary insomnia and affective disorder:a report of 35 cases]. [2018]

5. China pubmed.ncbi.nlm.nih.gov

[Modulation of transcutaneous auricular vagus nerve stimulation on default mode network in patients with primary insomnia]. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]

7. Austria pubmed.ncbi.nlm.nih.gov

Depression and ability to work after vestibular schwannoma surgery: a nationwide registry-based matched cohort study on antidepressants, sedatives, and sick leave. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Sex Differences in Vestibular Schwannoma. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Decision analysis of treatment options for vestibular schwannoma. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

Vestibular schwannomas in the modern era: epidemiology, treatment trends, and disparities in management. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Bevacizumab in neurofibromatosis type 2 (NF2) related vestibular schwannomas: a nationally coordinated approach to delivery and prospective evaluation. [2022]