Actively Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Led by Spark Biomedical, Inc. · Updated on 2026-04-08
80
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
S
Spark Biomedical, Inc.
Lead Sponsor
L
Lindus Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Delivering tAN to Reduce HMB: The LUNA Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Regularly menstruating female aged 14 to 45 years at time of screening
- History of menorrhagia as assessed by the Menorrhagia Screening Tool
- Stable and consistent use of current non-hormonal medications and supplements for the past three months, with willingness to continue for the study duration
- Reliable access to an internet-enabled device compatible with iOS 18 or Android 15 or greater
- Willingness to use only study-provided menstrual products throughout the study
- Participant Pictorial Bleeding Assessment Chart (PBAC) scores are 150 or higher for both baseline menstruation months
You will not qualify if you...
- Pregnancy within three months of enrollment
- Lactating at the time of enrollment
- Typical menstruation length greater than 14 days
- Use of antifibrinolytic medications within 14 days of enrollment
- Known acquired bleeding disorder
- Known severe bleeding disorder (mild von Willebrand disease allowed)
- Use of anticoagulants or platelet inhibitors within 14 days prior to enrollment
- Use of prescriptive pain medications or specific analgesics (Aspirin, naproxen, magnesium salicylate) during the study
- Use of copper intrauterine device within the past three months
- Structural cause of heavy menstrual bleeding documented in medical records
- Documented thrombocytopenia within the last 12 months
- Use of continuous hormone therapies within three months prior to enrollment
- Use of hormone therapies not following standard 21/7 dosing for at least six months prior
- History of chronic tobacco or nicotine use in past three months
- History of epileptic seizures within past 12 months
- History of neurologic diseases (stroke, brain tumor, cerebrovascular disease)
- History of traumatic brain injury within past 12 months
- History of splenectomy
- Presence of pacemakers, cochlear prostheses, neurostimulators, or use of other neurostimulators
- Abnormal ear anatomy or current ear infection
- Previous use of auricular neurostimulation
- Current or planned enrollment in another clinical trial
- Participant is a ward of the state
- Any other significant disease or disorder that may risk participant safety or affect study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lindus Health - DECENTRALIZED STUDY
Boston, Massachusetts, United States, 02111
Actively Recruiting
Research Team
L
Laura Mitchell
CONTACT
C
Caroline Benner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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