Actively Recruiting
Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding: The LUNA Study
Led by Spark Biomedical, Inc. · Updated on 2026-06-02
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Spark Biomedical, Inc.
Lead Sponsor
L
Lindus Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of transcutaneous auricular neurostimulation (tAN) in females aged 14 to 45 years who experience heavy menstrual bleeding (HMB) without a known structural cause. The LUNA study is a prospective, randomized, double-blind, sham-controlled clinical trial that includes two age groups: adolescents (14-21 years) and adults (22-45 years). It aims to assess the effects of tAN on menstrual bleeding and associated symptoms over five menstrual cycles. Participants will be randomly assigned to either an active tAN group or a sham (placebo) tAN group. The study begins with a two-cycle baseline phase (M1-M2) without any treatment, during which participants track blood loss and menstrual pain daily. In the following three treatment cycles (M3-M5), participants self-administer a daily 2-hour session of either active or sham tAN during menstruation. The active device stimulates nerves in the ear, while the sham device looks identical but delivers no stimulation. Throughout the study, participants will record daily blood loss using the Pictorial Bleeding Assessment Chart (PBAC) and pain levels with a Numerical Rating Scale (NRS). Additional assessments include menstrual symptom severity, quality of life questionnaires, and device usability surveys. All activities take place remotely over approximately five menstrual cycles (about 150 days). Participants continue their usual treatment for HMB as allowed and exit after completing the final treatment cycle.
CONDITIONS
Brief Title
Delivering tAN to Reduce HMB: The LUNA Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Regularly menstruating female aged 14-45 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 and willingness to continue during the study
- Reliable access to an internet-enabled device compatible with the study application (iOS 18 and Android 15 or greater)
- Willingness to consistently use only study-provided menstrual products throughout the study
- Participant PBAC scores are 150 or higher for both baseline menstruation months
You will not qualify if you...
- Pregnancy within three months of enrollment
- Currently lactating
- Typical menstruation lasting longer 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 aspirin, naproxen, or 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 a standard 21/7 dosing regimen for at least six months prior
- History of chronic tobacco or nicotine use in the past three months
- History of epileptic seizures in the past 12 months
- History of neurologic diseases such as stroke or brain tumor
- History of traumatic brain injury within the 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
- Being a ward of the state
- Any other significant disease or disorder that may pose risk or affect trial results or participation ability
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 menstrual cycles (M3-M5)
Participants self-administer one two-hour session of transcutaneous auricular neurostimulation (tAN) or a sham device each day of menstruation during the treatment phase.
Daily sessions during menstruation
Duration - Up to 5 complete menstrual cycles (estimated 150 days)
Participants complete questionnaires and assessments related to menstrual symptoms, bleeding, and device usability at the end of each menstruation.
Final day assessments of each menstruation, including days 3 and 5 for device usability
Trial Site Locations
Total: 1 location
1
Lindus Health - DECENTRALIZED STUDY
Boston, Massachusetts, United States, 02111
Actively Recruiting
Research Team
L
Laura Mitchell
C
Caroline Benner
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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