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Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients

Primary Purpose

Von Willebrand Disease, Type 1, Heavy Menstrual Bleeding

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Volta System
Sponsored by
Five Liters, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Von Willebrand Disease, Type 1 focused on measuring Transcutaneous auricular vagus nerve stimulation, Neurostimulation, Hemostasis, Menstrual cycle, Menstruation, Blood loss

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Regularly menstruating female participants between 18-45 years of age Diagnosis of von Willebrand Disease Type 1 History of menorrhagia as assessed by the Menstrual Bleeding Questionnaire On oral birth control (at least three months) and willing to continue use for the duration of the study No changes to all current medications and supplements in the past three months, willingness to continue use for duration of study, and not start any new medications or homeopathic remedies Reliable access to an Internet-enabled device to complete required questionnaires Willingness to consistently use the same brand of tampons and/or pads throughout duration of the study Exclusion Criteria: Pregnancy within three months of enrollment Lactating at the time of enrollment Antifibrinolytic use within 30 days of enrollment Acquired bleeding disorder Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment Known structural cause of heavy menstrual bleeding Use of menstrual cups as a method of menstrual blood collection Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months Participant has received a blood transfusion within 30 days prior to study Participant has a history of epileptic seizures Participant has a history of neurologic diseases or traumatic brain injury Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) Participant has abnormal ear anatomy or ear infection present Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Baseline Followed by Active tAN

    Arm Description

    First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN)

    Outcomes

    Primary Outcome Measures

    Blood loss during menses in von Willebrand Disease patients
    Comparison of mean Pictorial Bleeding Assessment Chart (PBAC) scores during first menstruation (no stimulation) versus second menstruation (active stimulation). The PBAC is a widely accepted tool for patients with HMB to account for menstrual blood loss. Menstrual blood loss is estimated through a selection of images of tampons, pads, clots, and flooding events. Patients mark a tally next to the images that best match each of the menstruation products they used that day. This trial will utilize a modified version of the Wyatt et al. 2001 PBAC, where a tally system will be added to each of the images.
    Quality of Life of von Willebrand Disease patients
    Comparison of mean quality of life score measured by the Short Form 36 (SF-36) during first menstruation (no stimulation) versus second menstruation (active stimulation). The SF-36 is a 36-item patient-reported questionnaire that assesses general quality of life. This questionnaire includes eight variables: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy and vitality, pain, and general perception of health. The SF-36 is scored using a standardized scoring algorithm or by the SF-36 scoring software. The SF-36 scores range from 0 to 100, with higher scores representing better health status.
    Duration and severity of dysmenorrhea in von Willebrand Disease patients
    Comparison of mean Cox Menstrual Symptom Scale (CMSS) scores during first menstruation (no stimulation) versus second menstruation (active stimulation). The CMSS measures menstrual distress and dysmenorrhea. The CMSS Severity subscale is an 18-item self-reported scale that measures severity of menstrual symptoms, including pain, nausea, emotions, etc. during menstruation. The CMSS will be used in this trial to measure a participant's dysmenorrhea every day of each menstruation. Each CMSS item is scored from 0-4, with a higher score indicating higher dysmenorrhea severity.
    Duration of menstruation in von Willebrand Disease patients
    Compare duration of menstruation between first menstruation (no stimulation) versus second menstruation (active stimulation).

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Five Liters, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06064851
    Brief Title
    Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients
    Official Title
    Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With Von Willebrand Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 6, 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Five Liters, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objectives of this study are to determine if transcutaneous auricular neurostimulation (tAN) can modulate hemostasis, improve perceived quality of life, and improve pain during the menstrual cycle of von Willebrand Disease (VWD) patients.
    Detailed Description
    This study is designed as an open label, decentralized clinical study in which patients with VWD and heavy menstrual bleeding (HMB) will receive tAN, which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled in the study over the course of two consecutive menstrual cycles. During the First Menstruation (baseline), no tAN treatment will be delivered. Participants will estimate blood loss and assess dysmenorrhea symptoms daily throughout the duration of the menstruation phase of their first menstrual cycle. A general quality of life assessment and total duration of menstruation will be collected on the final day of first menstruation. During the Second Menstruation, participants will self-administer 30 minutes of active tAN daily beginning Day 1 of menstruation through the final day of second menstruation. Participants will estimate blood loss and assess dysmenorrhea symptoms daily throughout the duration of the menstruation phase of their second menstruation. A general quality of life assessment and total duration of menstruation will be collected on the final day of second menstruation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Von Willebrand Disease, Type 1, Heavy Menstrual Bleeding
    Keywords
    Transcutaneous auricular vagus nerve stimulation, Neurostimulation, Hemostasis, Menstrual cycle, Menstruation, Blood loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Participants with VWD and HMB will be enrolled in the study over the course of two consecutive menstrual cycles. First Menstruation will be baseline. Second Menstruation participants will self-administer 30 minutes of active tAN daily beginning Day 1 of second menstruation through the final day of second menstruation.
    Masking
    None (Open Label)
    Masking Description
    No masking; open label
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Baseline Followed by Active tAN
    Arm Type
    Experimental
    Arm Description
    First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN)
    Intervention Type
    Device
    Intervention Name(s)
    Volta System
    Intervention Description
    The Volta System will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. During Second Menstruation, participants will self-administer 30 minutes of active tAN daily with the Volta System Device beginning Day 1 of second menstruation through the final day of second menstruation.
    Primary Outcome Measure Information:
    Title
    Blood loss during menses in von Willebrand Disease patients
    Description
    Comparison of mean Pictorial Bleeding Assessment Chart (PBAC) scores during first menstruation (no stimulation) versus second menstruation (active stimulation). The PBAC is a widely accepted tool for patients with HMB to account for menstrual blood loss. Menstrual blood loss is estimated through a selection of images of tampons, pads, clots, and flooding events. Patients mark a tally next to the images that best match each of the menstruation products they used that day. This trial will utilize a modified version of the Wyatt et al. 2001 PBAC, where a tally system will be added to each of the images.
    Time Frame
    Daily throughout both menstruations (up to 2 complete menstrual cycles- estimated 60 days)
    Title
    Quality of Life of von Willebrand Disease patients
    Description
    Comparison of mean quality of life score measured by the Short Form 36 (SF-36) during first menstruation (no stimulation) versus second menstruation (active stimulation). The SF-36 is a 36-item patient-reported questionnaire that assesses general quality of life. This questionnaire includes eight variables: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy and vitality, pain, and general perception of health. The SF-36 is scored using a standardized scoring algorithm or by the SF-36 scoring software. The SF-36 scores range from 0 to 100, with higher scores representing better health status.
    Time Frame
    Daily throughout both menstruations (up to 2 complete menstrual cycles- estimated 60 days)
    Title
    Duration and severity of dysmenorrhea in von Willebrand Disease patients
    Description
    Comparison of mean Cox Menstrual Symptom Scale (CMSS) scores during first menstruation (no stimulation) versus second menstruation (active stimulation). The CMSS measures menstrual distress and dysmenorrhea. The CMSS Severity subscale is an 18-item self-reported scale that measures severity of menstrual symptoms, including pain, nausea, emotions, etc. during menstruation. The CMSS will be used in this trial to measure a participant's dysmenorrhea every day of each menstruation. Each CMSS item is scored from 0-4, with a higher score indicating higher dysmenorrhea severity.
    Time Frame
    Daily throughout both menstruations (up to 2 complete menstrual cycles- estimated 60 days)
    Title
    Duration of menstruation in von Willebrand Disease patients
    Description
    Compare duration of menstruation between first menstruation (no stimulation) versus second menstruation (active stimulation).
    Time Frame
    Daily throughout both menstruations (up to 2 complete menstrual cycles- estimated 60 days)

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Regularly menstruating female participants.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Regularly menstruating female participants between 18-45 years of age Diagnosis of von Willebrand Disease Type 1 History of menorrhagia as assessed by the Menstrual Bleeding Questionnaire On oral birth control (at least three months) and willing to continue use for the duration of the study No changes to all current medications and supplements in the past three months, willingness to continue use for duration of study, and not start any new medications or homeopathic remedies Reliable access to an Internet-enabled device to complete required questionnaires Willingness to consistently use the same brand of tampons and/or pads throughout duration of the study Exclusion Criteria: Pregnancy within three months of enrollment Lactating at the time of enrollment Antifibrinolytic use within 30 days of enrollment Acquired bleeding disorder Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment Known structural cause of heavy menstrual bleeding Use of menstrual cups as a method of menstrual blood collection Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months Participant has received a blood transfusion within 30 days prior to study Participant has a history of epileptic seizures Participant has a history of neurologic diseases or traumatic brain injury Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) Participant has abnormal ear anatomy or ear infection present Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caroline Benner
    Phone
    210-624-8046
    Email
    hmbstudy@fiveliters.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Brooke Le
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Navid Khodaparast, PhD
    Organizational Affiliation
    Chief Science Officer
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Melanie McWade, PhD
    Organizational Affiliation
    Senior Director of Clinical Operations
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients

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