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

Primary Purpose

Breast Cancer, Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transauricular Vagus Nerve Stimulation
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring taVNS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • UAB Lakeshore Collaborative (WHARF)Recruiting
  • UAB Spain Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

taVNS

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 31, 2023
Last Updated
September 26, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT06006299
Brief Title
Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)
Official Title
Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Insomnia
Keywords
taVNS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All of the participants who are eligible will be in the taVNS group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
taVNS
Arm Type
Experimental
Arm 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(s)
transauricular Vagus Nerve Stimulation
Intervention 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.
Primary Outcome Measure Information:
Title
Feasibility of using transauricular Vagus Nerve Stimulation to treat insomnia in individuals with stage I-IV breast cancer.
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Insomnia Severity Index
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.
Time Frame
2 months
Title
The Pittsburgh Sleep Quality Index (PSQI)
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.
Time Frame
2 months
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Assessment (Short Form)
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.
Time Frame
2 months
Title
Generalized Anxiety Disorder 7 (GAD-7)
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.
Time Frame
2 months
Title
Patient Health Questionnaire-9 (PHQ-9)
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.
Time Frame
2 months
Title
Cancer Fatigue Scale (CFS)
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.
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Evancho, DPT
Phone
(205)447-6846
Email
amelgin@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Reed, PhD
Email
wend@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Evancho, DPT
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Lakeshore Collaborative (WHARF)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Evancho, DPT
Phone
205-447-6846
Email
amelgin@uab.edu
Facility Name
UAB Spain Rehabilitation Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Evancho, DPT
Phone
205-447-6846
Email
amelgin@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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