Neurostimulation for Heavy Menstrual Bleeding
(LUNA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), or sham stimulation. Participants will be enrolled into the study over the course of five consecutive menstrual cycles. All study activities will occur remotely and in addition to participants' typical treatment for HMB (as allowed by the eligibility criteria).
During the first two consecutive menstrual cycles (M1 - M2, "Baseline Phase"), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC), and menstrual cramp pain will be assessed with a Numerical Rating Scale (NRS), daily throughout the duration of the menstruation phase of their two baseline menstrual cycles. 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 RAND Short-Form 36 (RAND-36). Menstrual-related quality of life assessments will also be conducted on the final day of each menstruation using the Menstrual Bleeding Questionnaire (MBQ) in the adult cohort, and the adolescent version (aMBQ) in the adolescent cohort.
During the following three consecutive menstruations (M3 - M5, "Treatment Phase"), participants will self-administer one 2-hour sham or active tAN session daily, beginning Day 1 of menstruation through the final day of menstruation in each menstrual cycle. Blood loss (via the PBAC) and menstrual cramp pain (via the NRS) will be assessed daily throughout the duration of each menstruation. Quality of life will be assessed with the CMSS, RAND-36, and the MBQ (adults) or aMBQ (adolescents) on the final day of each menstruation. A device usability survey will be completed at the end of M3 and M5. Participants will exit the study after the final day of M5.
Who Is on the Research Team?
Navid Khodaparast, PhD
Principal Investigator
Spark Biomedical, Inc.
Are You a Good Fit for This Trial?
The LUNA study is for females aged 14-45 with heavy menstrual bleeding who have regular periods and no structural cause for their symptoms. They must use non-hormonal treatments consistently, avoid starting new medications, and be willing to only use provided menstrual products during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Phase
Participants estimate blood loss and assess menstrual cramp pain without tAN treatment
Treatment Phase
Participants self-administer daily sham or active tAN sessions and assess blood loss and pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous Auricular Neurostimulation (tAN)
Trial Overview
This trial tests transcutaneous auricular neurostimulation (tAN) against a sham device in reducing heavy menstrual bleeding over five cycles. Participants will self-administer sessions daily during menstruation in the latter three cycles and complete various quality of life assessments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
In the Treatment Phase (M3-M5), participants will self-administer one two-hour session of active transcutaneous auricular neurostimulation (tAN) each day of menstruation.
In the Treatment Phase (M3-M5), participants will self-administer one two-hour session of sham transcutaneous auricular neurostimulation (tAN) each day of menstruation. Participants in the sham group will apply the earpiece and connect the cable to the Patient Controller. The device will be turned on, and appears to function identically to an active device, but will not deliver stimulation through the earpiece.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spark Biomedical, Inc.
Lead Sponsor
Lindus Health
Industry Sponsor
Wellcome Leap
Collaborator
Oregon Health and Science University
Collaborator
University of Michigan Health
Collaborator
Yale University
Collaborator
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