xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06006299</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-300010460</org_study_id>
      <nct_id>NCT06006299</nct_id>
    </id_info>
    <brief_title>Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)</brief_title>
    <official_title>Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alabama at Birmingham</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Alabama at Birmingham</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        In the present study, the investigators aim to investigate feasibility of utilizing&#xD;
        noninvasive neuromodulation, specifically taVNS, as a nonpharmacologic approach to address&#xD;
        insomnia in patients with stage I-IV breast cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will evaluate the feasibility, safety, and tolerability of nightly, at-home&#xD;
        self-administered taVNS treatments. Study staff will monitor for adverse reactions,&#xD;
        unanticipated adverse device events and severe adverse events as described to evaluate&#xD;
        safety, tolerability, and biocompatibility. Additionally, investigators will estimate effect&#xD;
        size by collecting outcome assessment data as described below. An additional objective is to&#xD;
        use information gained through this study to inform product development activities. Specific&#xD;
        information about the comfort, ease of use, and other user subject feedback will be used to&#xD;
        inform future product development efforts for optimizing device designs.&#xD;
  &#xD;
        Specific Aim 1: To evaluate the feasibility of using taVNS for patients with breast cancer to&#xD;
        treat insomnia. HYPOTHESIS: Investigators expect that 40 patients with stage I-III breast&#xD;
        cancer and insomnia will be enrolled and undergo taVNS to address insomnia, quantified by&#xD;
        various sleep related outcome measures, with an estimated recruitment rate of 70%,&#xD;
        eligibility rate of 70%, completion rate of 80%, and follow up rate of 80%.&#xD;
  &#xD;
        Specific Aim 2: To evaluate the efficacy of repeated, nightly taVNS on sleep quality,&#xD;
        anxiety, and cancer related fatigue. HYPOTHESIS: Investigators hypothesize that patients will&#xD;
        report improved sleep, anxiety, depression, and cancer related fatigue after one week of&#xD;
        taVNS.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>All of the participants who are eligible will be in the taVNS group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.</measure>
      <time_frame>2 months</time_frame>
      <description>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 &gt;70%, a completion rate of 80% of the protocol, and a follow up rate of 80% will be considered successful.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index</measure>
      <time_frame>2 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>2 months</time_frame>
      <description>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.&#xD;
  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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Assessment (Short Form)</measure>
      <time_frame>2 months</time_frame>
      <description>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.&#xD;
  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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder 7 (GAD-7)</measure>
      <time_frame>2 months</time_frame>
      <description>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:&#xD;
  0 to 4: Minimal anxiety 5 to 9: Mild anxiety 10 to 14: Moderate anxiety 15 to 21: Severe anxiety&#xD;
  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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
      <time_frame>2 months</time_frame>
      <description>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:&#xD;
  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&#xD;
  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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cancer Fatigue Scale (CFS)</measure>
      <time_frame>2 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Insomnia</condition>
    <arm_group>
      <arm_group_label>taVNS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>transauricular Vagus Nerve Stimulation</intervention_name>
      <description>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 &lt;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.</description>
      <arm_group_label>taVNS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. at least 18 years of age&#xD;
  &#xD;
            2. diagnosed stage I-IV breast cancer&#xD;
  &#xD;
            3. self-reported difficulty falling asleep, staying asleep, or waking up too early, for&#xD;
               at least three nights per week for a duration of at least three months&#xD;
  &#xD;
            4. beginning or worsening of sleep disturbance since cancer diagnosis (did your sleep&#xD;
               problems begin or get worse with the diagnosis of cancer or with chemotherapy?)&#xD;
  &#xD;
            5. English-speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Are using a daily sleep aid except melatonin (use of a sleep aid as needed will be&#xD;
               permitted, and use will be noted).&#xD;
  &#xD;
            2. have a history of severe mental illness&#xD;
  &#xD;
            3. have an implanted medical device of any type&#xD;
  &#xD;
            4. have a history of seizures&#xD;
  &#xD;
            5. have peripheral neuropathy including temporal mandibular disorders and Bells Palsy&#xD;
  &#xD;
            6. have vasovagal syncope&#xD;
  &#xD;
            7. have moderate to severe cognitive impairment&#xD;
  &#xD;
            8. have &lt;6 months to live as determined by the physician&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alexandra Evancho, DPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Alabama at Birmingham</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexandra Evancho, DPT</last_name>
      <phone>(205)447-6846</phone>
      <email>amelgin@uab.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wendy Reed, PhD</last_name>
      <email>wend@uab.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
      <investigator_full_name>Alexandra Evancho</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>taVNS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06006299
  org study id: IRB-300010460
  nct id: NCT06006299
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All of the participants who are eligible will be in the taVNS group.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.
  time frame: 2 months
  description: 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.
  measure: Insomnia Severity Index
  time frame: 2 months
  description: 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.
  measure: The Pittsburgh Sleep Quality Index (PSQI)
  time frame: 2 months
  description: 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.
  measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Assessment (Short Form)
  time frame: 2 months
  description: 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.
  measure: Generalized Anxiety Disorder 7 (GAD-7)
  time frame: 2 months
  description: 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.
  measure: Patient Health Questionnaire-9 (PHQ-9)
  time frame: 2 months
  description: 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.
  measure: Cancer Fatigue Scale (CFS)
  time frame: 2 months
  description: 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.
  arm group label: taVNS
  arm group type: Experimental
  description: 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.
  intervention type: Device
  intervention name: transauricular Vagus Nerve Stimulation
  description: 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.
  arm group label: taVNS
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alexandra Evancho, DPT
  role: Principal Investigator
  affiliation: The University of Alabama at Birmingham
  last name: Alexandra Evancho, DPT
  phone: (205)447-6846
  email: amelgin@uab.edu
  last name: Wendy Reed, PhD
  email: wend@uab.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Alabama at Birmingham
  investigator full name: Alexandra Evancho
  investigator title: Assistant Professor
  mesh term: Breast Neoplasms
  mesh term: Sleep Initiation and Maintenance Disorders
  sharing ipd: No