Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients
Von Willebrand Disease, Type 1, Heavy Menstrual Bleeding
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
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
Experimental
Baseline Followed by Active tAN
First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN)