Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Blood loss
研究概览
简要总结
This study is designed as an open label, single-arm, decentralized research study in which patients with idiopathic heavy menstrual bleeding will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled over the course of three menstruations: one baseline menstruation and two menstruations with added daily neurostimulation.
详细描述
This study is designed as an open label, single arm, cross-over decentralized clinical study in which patients with idiopathic heavy menstrual bleeding will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) via the mastoid and the auriculotemporal nerve (ATN) anterior to the tragus. Participants will be enrolled into the study over the course of three consecutive menstrual cycles.
During the First Menstruation (baseline), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC) daily throughout the duration of the menstruation phase of their menstrual cycle. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the Short-Form 36 (SF-36).
During the Second Menstruation, participants will self-administer two 1-hour active tAN sessions daily (once in the AM, once in the PM), beginning Day 1 of menstruation through the final day of menstruation. Blood loss will be assessed daily using the PBAC throughout the duration of menstruation. Quality of life will be assessed with the CMSS and SF-36 on the final day of menstruation.
During the Third Menstruation, participants will self-administer a single 2-hour active tAN session each day, beginning Day 1 of menstruation through the final day of menstruation. Blood loss will be assessed daily using the PBAC throughout the duration of menstruation. Quality of life will be assessed with the CMSS and SF-36 on the final day of menstruation.
In addition, a device satisfaction survey will be completed at the end of the study. Participants will exit the study after the final day of their third menstruation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Regularly menstruating female participants between 18-45 years of age
- •History of menorrhagia as assessed by the Menorrhagia Screening Tool
- •Stable/consistent use of current medications and supplements for 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
排除标准
- •Pregnancy within three months of enrollment
- •Lactating at the time of enrollment
- •Typical length of menstruation greater than 14 days
- •Use of hormone therapy in the past three months
- •Antifibrinolytic use within 30 days of enrollment
- •Known inherited or acquired bleeding disorder
- •Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment
- •Use of the Copper intrauterine device within the past 3 months
- •Known structural cause of heavy menstrual bleeding
- •Use of menstrual cups or menstrual underwear 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
结局指标
主要结局
Blood loss
时间窗: Daily throughout all three menstruations (up to 3 complete menstrual cycles - estimated 90 days)
Comparison of mean Pictorial Bleeding Assessment Chart (PBAC) scores during first menstruation (no stimulation) versus second and third menstruations (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.
Quality of life
时间窗: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)
Comparison of mean quality of life score measured by the Short Form 36 (SF-36) during first menstruation (no stimulation) versus second and third menstruations (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
时间窗: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)
Comparison of mean Cox Menstrual Symptom Scale (CMSS) scores during first menstruation (no stimulation) versus second and third menstruations (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.
次要结局
未报告次要终点