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Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients — HMB/VWD  

Heavy Menstrual Bleeding Clinical Trial

Official title:
Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With Von Willebrand Disease

Clinical Trial 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.

Clinical Trial 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 daily throughout the duration of the menstruation phase of their first menstrual cycle. Dysmenorrhea, 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 2, 1-hour sessions (daily total of 2 hours) of active tAN daily beginning Day 1 of menstruation through the final day of second menstruation. Participants will estimate blood loss daily throughout the duration of the menstruation phase of their second menstruation. Dysmenorrhea, a general quality of life assessment, and total duration of menstruation will be collected on the final day of second menstruation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06064851
Study type Interventional
Source Spark Biomedical, Inc.
Contact Caroline Benner
Phone 210-624-8046
Email hmbstudy@fiveliters.com
Status Recruiting
Phase N/A
Start date October 27, 2023
Completion date September 2024
View Details
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