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Device

taVNS for Insomnia in Breast Cancer Patients

N/A

Recruiting

Led By Alexandra Evancho, DPT

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Diagnosed stage I-IV breast cancer

Must not have

Have a history of seizures

Have peripheral neuropathy including temporal mandibular disorders and Bells Palsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will look into using a non-medicine approach to help people with breast cancer sleep better.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

taVNS may cause discomfort at the stimulation site on the ear. There could be rare risks like fainting (vasovagal syncope) or an abnormal sensation on the face due to nerve stimulation but generally considered low-risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with breast cancer at any stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had seizures in the past.

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I have nerve damage, including issues with my jaw or facial paralysis.

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I have fainting spells due to sudden drops in heart rate or blood pressure.

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I have significant memory or thinking problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.

Secondary study objectives

Cancer Fatigue Scale (CFS)

Generalized Anxiety Disorder 7 (GAD-7)

Insomnia Severity Index

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met