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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Cancer Fatigue Scale (CFS)

Generalized Anxiety Disorder 7 (GAD-7)

Insomnia Severity Index

+3 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,622 Total Patients Enrolled

31 Trials studying Breast Cancer

4,451 Patients Enrolled for Breast Cancer

Alexandra Evancho, DPTPrincipal InvestigatorThe University of Alabama at Birmingham

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being recruited for this clinical trial?

"Affirmative. Per the information available on clinicaltrials.gov, this experiment is currently searching for 40 volunteers distributed across 2 sites. The trial was initially posted on September 26th 2023 with a most recent update being made on that same day."

Answered by AI

Are there any current opportunities to enroll in this experiment?

"Yes, the details on clinicaltrials.gov allude to this trial's ongoing recruitment process. The trial was first listed on September 26th 2023 and has since been revised accordingly. For completion of the study, 40 patients need to be acquired from 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)

Alexandra Evancho 2023. "Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06006299.