Breast CancerPhase 1NCT06006299
Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)
A Phase 1 study testing transauricular Vagus Nerve Stimulation in people with Breast Cancer and Insomnia, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Insomnia
- What is being tested?
- transauricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Sep 2023to 9 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- diagnosed stage I-IV breast cancer
- self-reported difficulty falling asleep, staying asleep, or waking up too early, for at least three nights per week for a duration of at least three months
- beginning or worsening of sleep disturbance since cancer diagnosis (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?)
- English-speaking
Who cannot join
- Are using a daily sleep aid except melatonin (use of a sleep aid as needed will be permitted, and use will be noted).
- have a history of severe mental illness
- have an implanted medical device of any type
- have a history of seizures
- have peripheral neuropathy including temporal mandibular disorders and Bells Palsy
- have vasovagal syncope
- have moderate to severe cognitive impairment
- have <6 months to live as determined by the physician
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UAB Lakeshore Collaborative (WHARF)
Birmingham, Alabama, 35209
UAB Spain Rehabilitation Center
Birmingham, Alabama, 35233
About this study
Official title: Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer
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.
Read the detailed description
The study will evaluate the feasibility, safety, and tolerability of nightly, at-home self-administered taVNS treatments. Study staff will monitor for adverse reactions, unanticipated adverse device events and severe adverse events as described to evaluate safety, tolerability, and biocompatibility. Additionally, investigators will estimate effect size by collecting outcome assessment data as described below. An additional objective is to use information gained through this study to inform product development activities. Specific information about the comfort, ease of use, and other user subject feedback will be used to inform future product development efforts for optimizing device designs.
Specific Aim 1: To evaluate the feasibility of using taVNS for patients with breast cancer to treat insomnia. HYPOTHESIS: Investigators expect that 40 patients with stage I-III breast cancer and insomnia will be enrolled and undergo taVNS to address insomnia, quantified by various sleep related outcome measures, with an estimated recruitment rate of 70%, eligibility rate of 70%, completion rate of 80%, and follow up rate of 80%.
Specific Aim 2: To evaluate the efficacy of repeated, nightly taVNS on sleep quality, anxiety, and cancer related fatigue. HYPOTHESIS: Investigators hypothesize that patients will report improved sleep, anxiety, depression, and cancer related fatigue after one week of taVNS.
- Conditions
- Breast Cancer, Insomnia
- Being tested
- transauricular Vagus Nerve Stimulation
- Keywords
- taVNS
- Medical subject headings
- Breast Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transauricular Vagus Nerve StimulationDevice
Transcutaneous auricular vagus nerve stimulation (taVNS) is a form of transcutaneous electrical nerve stimulation (TENS) applied to peripheral nerves, considered a low-risk procedure. It involves the use of standard neurostimulation electrodes placed on the surface of the external ear. The taVNS method delivers low-intensity, pulsed electrical currents with a peak current amplitude of <4 mA, which is significantly lower than those used in most over-the-counter TENS devices for pain relief or muscle stimulation. By targeting the auricular branches of the vagus nerve, taVNS aims to stimulate specific neural pathways associated with various indications and intended uses. This non-invasive approach has broad applications in research, medical device treatments, health products, and cosmetic or lifestyle products.
| Study group | Role | What they receive |
|---|---|---|
| taVNS | Experimental | 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. Receives: Device: transauricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.
Our mixed method approach for evaluating feasibility includes measuring eligibility rates, retention rates, refusal rates, and follow-up rates as well as analyzing information gathered from interviews. In this feasibility study, a recruitment rate of at least 70% within 6 weeks, an eligibility rate of >70%, a completion rate of 80% of the protocol, and a follow up rate of 80% will be considered successful.
Measured: 2 months
Secondary outcomes (6)
Insomnia Severity Index
The Insomnia Severity Index (ISI) is a seven-question survey that is commonly used to identify and quantify the severity of insomnia over the past 2 weeks. Using a five-point Likert-type scale, it asks questions regarding difficulty falling asleep and maintaining sleep, satisfaction with sleep, noticeability of sleep disturbances, and distress. Out of total possible score of 28, a score of 8 is generally regarded as the optimal cut-off for clinical significance and a score of 15 indicates chronic insomnia syndrome.
Measured: 2 months
The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire designed to assess sleep quality and disturbances in individuals. It is a valuable tool in evaluating the severity of insomnia and other sleep-related issues.
The PSQI generates a total score that ranges from 0 to 21, with higher scores indicating poorer sleep quality. A lower PSQI score suggests better sleep quality and fewer sleep disturbances, while a higher score implies more significant sleep problems and reduced overall sleep satisfaction. The index considers various aspects of sleep, including sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. The score helps to quantify and categorize individuals' sleep patterns, enabling healthcare professionals to identify sleep-related issues and develop appropriate interventions to improve sleep quality and overall well-being.
Measured: 2 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Assessment (Short Form)
The PROMIS Anxiety Assessment Short Form is a concise and validated self-report questionnaire used to evaluate anxiety symptoms in individuals. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS) toolset, widely recognized for assessing various health-related aspects.
The PROMIS Anxiety Assessment Short Form generates a score that reflects the severity of anxiety symptoms experienced by an individual. The score is standardized, with higher values indicating higher levels of anxiety. Conversely, lower scores represent less severe anxiety symptoms. By utilizing this assessment, healthcare professionals can quantify and monitor anxiety levels in patients, aiding in the identification of anxiety-related issues and facilitating personalized interventions for improved mental well-being.
Measured: 2 months
Generalized Anxiety Disorder 7 (GAD-7)
The GAD-7 generates a total score ranging from 0 to 21, with higher scores indicating higher levels of anxiety symptom severity. The score is typically interpreted as follows:
0 to 4: Minimal anxiety 5 to 9: Mild anxiety 10 to 14: Moderate anxiety 15 to 21: Severe anxiety
A lower GAD-7 score suggests minimal to mild anxiety, while higher scores indicate moderate to severe anxiety symptoms. Healthcare professionals utilize the GAD-7 to assess and monitor anxiety levels in individuals, helping to guide treatment decisions and interventions aimed at improving mental well-being and overall quality of life.
Measured: 2 months
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 generates a total score ranging from 0 to 27, with higher scores indicating higher levels of depressive symptom severity. The score is typically interpreted as follows:
0 to 4: Minimal or no depression 5 to 9: Mild depression 10 to 14: Moderate depression 15 to 19: Moderately severe depression 20 to 27: Severe depression
A lower PHQ-9 score suggests minimal or no depression, while higher scores indicate varying degrees of depressive symptoms. Healthcare professionals use the PHQ-9 to assess and monitor depression levels in individuals, facilitating treatment decisions and interventions aimed at improving mental well-being and overall quality of life.
Measured: 2 months
Cancer Fatigue Scale (CFS)
The Cancer Fatigue Scale (CFS) is a self-report questionnaire designed to assess an individual's sense of fatigue in the context of cancer-related fatigue. The questionnaire consists of 15 questions, and participants are asked to rate their current state of fatigue on a scale from 1 (No) to 5 (Very Much). The scale measures three different aspects of fatigue: physical, affective, and cognitive.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start26 Sep 2023
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All of the participants who are eligible will be in the taVNS group.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Evancho, University of Alabama at Birmingham
- Investigators
- Alexandra Evancho, DPT, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006299
- Sponsor's protocol ID
- IRB-300010460
- Other IDs
- PREP grant
- Status last verified
- Sep 2025
- First submitted
- 31 Jul 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Do M, Evancho A, Tyler WJ. Bilateral transcutaneous auricular vagus nerve stimulation for the treatment of insomnia in breast cancer. Sci Rep. 2025 Dec 4;16(1):1081. doi: 10.1038/s41598-025-30600-6.
PubMed 41345210
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer
- ClinicalTrials.gov ID
- NCT06006299
- Acronym / sponsor ID
- IRB-300010460
- Conditions
- Breast Cancer, Insomnia
- Keywords
- taVNS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will evaluate the feasibility, safety, and tolerability of nightly, at-home self-administered taVNS treatments. Study staff will monitor for adverse reactions, unanticipated adverse device events and severe adverse events as described to evaluate safety, tolerability, and biocompatibility. Additionally, investigators will estimate effect size by collecting outcome assessment data as described below. An additional objective is to use information gained through this study to inform product development activities. Specific information about the comfort, ease of use, and other user subject feedback will be used to inform future product development efforts for optimizing device designs.
Specific Aim 1: To evaluate the feasibility of using taVNS for patients with breast cancer to treat insomnia. HYPOTHESIS: Investigators expect that 40 patients with stage I-III breast cancer and insomnia will be enrolled and undergo taVNS to address insomnia, quantified by various sleep related outcome measures, with an estimated recruitment rate of 70%, eligibility rate of 70%, completion rate of 80%, and follow up rate of 80%.
Specific Aim 2: To evaluate the efficacy of repeated, nightly taVNS on sleep quality, anxiety, and cancer related fatigue. HYPOTHESIS: Investigators hypothesize that patients will report improved sleep, anxiety, depression, and cancer related fatigue after one week of taVNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All of the participants who are eligible will be in the taVNS group.
| Arm | Type | Receives |
|---|---|---|
| taVNS | Experimental | Device: transauricular Vagus Nerve StimulationParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 18 years of age
- diagnosed stage I-IV breast cancer
- self-reported difficulty falling asleep, staying asleep, or waking up too early, for at least three nights per week for a duration of at least three months
- beginning or worsening of sleep disturbance since cancer diagnosis (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?)
- English-speaking
Key exclusion criteria (8 listed)
- Are using a daily sleep aid except melatonin (use of a sleep aid as needed will be permitted, and use will be noted).
- have a history of severe mental illness
- have an implanted medical device of any type
- have a history of seizures
- have peripheral neuropathy including temporal mandibular disorders and Bells Palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transauricular Vagus Nerve StimulationTranscutaneous auricular vagus nerve stimulation (taVNS) is a form of transcutaneous electrical nerve stimulation (TENS) applied to peripheral nerves, considered a low-risk procedure. It involves the use of standard neurostimulation electrodes placed on the surface of the external ear. The taVNS method delivers low-intensity, pulsed electrical currents with a peak current amplitude of <4 mA, which is significantly lower than those used in most over-the-counter TENS devices for pain relief or muscle stimulation. By targeting the auricular branches of the vagus nerve, taVNS aims to stimulate specific neural pathways associated with various indications and intended uses. This non-invasive approach has broad applications in research, medical device treatments, health products, and cosmetic or lifestyle products. | Device | taVNS |
Primary outcome
Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.
Time frame: 2 months
Our mixed method approach for evaluating feasibility includes measuring eligibility rates, retention rates, refusal rates, and follow-up rates as well as analyzing information gathered from interviews. In this feasibility study, a recruitment rate of at least 70% within 6 weeks, an eligibility rate of >70%, a completion rate of 80% of the protocol, and a follow up rate of 80% will be considered successful.
6 secondary outcomes
Insomnia Severity Index
Time frame: 2 months
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Assessment (Short Form)
Time frame: 2 months
Generalized Anxiety Disorder 7 (GAD-7)
Time frame: 2 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 2 months
Cancer Fatigue Scale (CFS)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 41345210Do M, Evancho A, Tyler WJ. Bilateral transcutaneous auricular vagus nerve stimulation for the treatment of insomnia in breast cancer. Sci Rep. 2025 Dec 4;16(1):1081. doi: 10.1038/s41598-025-30600-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Evancho, DPT principal investigator
The University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing transauricular Vagus Nerve Stimulation in people with Breast Cancer and Insomnia, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.