taVNS for Insomnia in Breast Cancer Patients

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a noninvasive device called transauricular Vagus Nerve Stimulation (taVNS) can aid breast cancer patients with sleep difficulties. The researchers are investigating whether this device can enhance sleep without medication. Participants will use the device for 15 minutes before bed each night for two weeks, and researchers will collect feedback through surveys and sleep diaries. The trial seeks individuals with stage I-IV breast cancer who have experienced sleep problems at least three times a week for three months, particularly if these issues began or worsened after their cancer diagnosis. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve sleep quality for breast cancer patients.

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 prior data suggests that this technique is safe for breast cancer patients with insomnia?

Research has shown that transauricular Vagus Nerve Stimulation (taVNS) is generally safe and well-tolerated. One study on people with chronic insomnia found that taVNS improved sleep quality and reduced symptoms without significant side effects. Another study confirmed its safety in a controlled setting, suggesting it could serve as a good alternative therapy. Overall, taVNS is considered a safe option for improving sleep and other symptoms related to insomnia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard insomnia treatments, which often involve medications like benzodiazepines or cognitive behavioral therapy, transauricular Vagus Nerve Stimulation (taVNS) offers a unique approach by targeting the vagus nerve through the ear. This non-invasive method could potentially minimize side effects commonly associated with medications, such as dependency or daytime drowsiness. Researchers are excited about taVNS because it provides a new way to enhance sleep quality without the need for pharmaceuticals, making it an innovative option for breast cancer patients who may already be managing complex medication regimens.

What evidence suggests that taVNS is effective for insomnia in breast cancer patients?

Research has shown that stimulating the vagus nerve through the ear, known as transauricular Vagus Nerve Stimulation (taVNS), can help reduce insomnia symptoms. In this trial, participants will use the taVNS device for 14 days, 15 minutes before sleeping. Previous clinical trials demonstrated that taVNS significantly lessened the severity of insomnia and improved sleep quality. This suggests it could be an effective non-drug treatment for insomnia, especially for breast cancer patients who often have trouble sleeping. The treatment calms the nervous system, which can lead to better sleep. Early results are promising, indicating that taVNS might be a useful option for those seeking to improve their sleep without medication. ^{1 2 6 7 8}

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) 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]

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]

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]

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 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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06006299

Investigating the Use of taVNS to Treat Insomnia in ... Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer. Our mixed method approach for ...

2. researchsquare.com researchsquare.com/article/rs-7171546/v1.pdf?c=1754310407000

Bilateral transcutaneous auricular vagus nerve stimulation ... Notably, breast cancer patients report the highest rates of insomnia and fatigue, with prevalence estimates ranging from 38–70%, compared to ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828072

Transcutaneous Auricular Vagus Nerve Stimulation for ... In this randomized clinical trial, taVNS significantly reduced insomnia severity. Clinically meaningful enhancements in PSQI scores were observed compared with ...

4. sciety-labs.elifesciences.org sciety-labs.elifesciences.org/articles/by?article_doi=10.21203/rs.3.rs-7171546/v2

Bilateral transcutaneous auricular vagus nerve stimulation for ... Bilateral transcutaneous auricular vagus nerve stimulation for the treatment of insomnia in breast cancer ... outcomes in breast cancer patients ...

5. researchgate.net researchgate.net/publication/394270866_Bilateral_transcutaneous_auricular_vagus_nerve_stimulation_for_the_treatment_of_insomnia_in_breast_cancer

(PDF) Bilateral transcutaneous auricular vagus nerve ... patients. DISCUSSION. Despite the high prevalence of sleep disturbances in breast cancer survivors, fewer than 50% of. survivorship programs at ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945725002540

Transcutaneous auricular vagus nerve stimulation (taVNS ... Highlights · TaVNS improved sleep quality and symptom severity in chronic insomnia. · The study confirmed its efficacy and safety through a sham-controlled trial.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12174914/

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS ... Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and highly tolerated method, and it might be an alternative therapy for patients with ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06006299?locn=UAB&aggFilters=status:rec&rank=2

NCT06006299 | Investigating the Use of taVNS to Treat ... HYPOTHESIS: Investigators hypothesize that patients will report improved sleep, anxiety, depression, and cancer related fatigue after one week of taVNS.