Understanding the LUNA Study: How Wearable Neurostimulation is Being Tested to Treat Heavy Periods
If you've been dealing with heavy periods, you know it’s more than “just that time of the month.” Heavy menstrual bleeding (HMB) can take over your calendar, your energy, and your peace of mind. At OhmBody, we believe women deserve better options. That's why we're excited to share what's happening with the LUNA study, a major research study designed to test how wearable neurostimulation can help reduce heavy menstrual bleeding. Here’s what that means, how the study works, and why it matters for you.
What Is the LUNA Study?
LUNA stands for Lessening Uncomfortable Menstrual Symptoms with Auricular Neurostimulation. This clinical trial examines whether transcutaneous auricular neurostimulation (tAN) —a wearable, non-invasive, non-hormone based treatment —can effectively reduce heavy menstrual bleeding.
The study follows rigorous scientific protocols:
- Randomized – Participants are chosen by chance to receive either the active tAN treatment or a sham (a look-alike treatment ).
- Double-blind – Neither the participant nor the study team knows who is getting the real treatment during the study.
- Decentralized – Everything happens from home. No clinic visits are required.
This design helps us get strong, trustworthy results.
Who Is in the Study?
The study will enroll 80 females across the United States from two distinct cohorts:
- Adolescents: ages 14-21
- Adults: ages 22-45
All participants must have regularly occurring periods and experience heavy menstrual bleeding without a known structural cause. This means their excessive bleeding isn't attributed to conditions like uterine fibroids or polyps—it's occurring without an identifiable underlying structural abnormality.
How the Study Works
The LUNA study follows participants through five consecutive menstrual cycles, divided into two distinct phases:
Baseline Phase (Menstrual Cycles 1-2)
During the first two cycles, participants track their typical menstrual experience without any treatment. They measure daily blood loss, cramp severity, menstrual symptoms, and quality of life using standardized assessment tools. This baseline data provides researchers with an accurate picture of each participant's normal menstrual pattern.
Treatment Phase (Menstrual Cycles 3-5)
During the next three cycles, participants will wear the tAN earpiece and deliver stimulation for 2-hours daily during menstruation. The study uses a double-blind design—the gold standard in clinical research. Participants are randomly assigned to receive either active tAN or sham stimulation. Neither participants nor researchers know which treatment is being given until the study ends. This eliminates bias and ensures scientific integrity.
Study Objectives
The primary objective is determining whether active tAN significantly reduces menstrual blood loss compared to sham treatment. Researchers are investigating whether participants achieve a clinically meaningful reduction in menstrual blood loss. The study also examines the efficacy of wearable neurostimulation to reduce other menstrual symptoms like pain, bloating and fatigue, as well as overall quality of life improvements. Safety is closely monitored, comparing side effects between the active and sham groups to make sure the treatment is safe.
The Science Behind the Technology
Transcutaneous auricular neurostimulation involves:
- Transcutaneous: delivering stimulation through intact skin (non-invasive)
- Auricular: targeting nerves in the external ear
- Neurostimulation: applying controlled electrical impulses to activate specific nerves
The device used in this study specifically targets two neural pathways:
- The auricular branch of the vagus nerve (ABVN)
- The auriculotemporal nerve (ATN), a branch of the trigeminal nerve.
These nerves interface with the body's autonomic nervous system, which regulates involuntary physiological functions including vascular control. By modulating these neural pathways, the technology may influence mechanisms that regulate menstrual blood flow and associated discomfort.
Why This Research Matters
Heavy menstrual bleeding affects millions of women globally and can lead to anemia (iron deficiency), yet treatment options remain limited:
- Hormonal contraceptives (which have side effects and don't work for everyone)
- Surgical interventions (which are invasive and may impact fertility)
- Enduring symptoms without intervention (which shouldn't be the default)
The LUNA study investigates whether an alternative exists— a treatment that is:
- Non-invasive and drug-free
- Self-administered at home
- Compatible with existing treatment regimens
Funding and Recognition: The Missed Vital Sign Program
Spark Biomedical, the company behind the LUNA study, was selected as one of only 13 projects funded by Wellcome Leap's prestigious Missed Vital Sign Program. This $50 million initiative represents a major investment in advancing women's health research.
Wellcome Leap is an organization dedicated to funding unconventional, high-impact health research projects. The Missed Vital Sign Program operates on a revolutionary premise: menstruation should be treated as a vital sign—just like blood pressure, heart rate, or body temperature.
Currently, women with heavy menstrual bleeding wait an average of 5 years before receiving effective treatment. This delay occurs because symptoms are normalized, diagnostic tools are inadequate, and treatment options are limited. The Missed Vital Sign Program aims to demonstrate that when menstruation is properly monitored and addressed, this timeline can be reduced dramatically—from 5 years to just 5 months. By supporting the LUNA study, Wellcome Leap validates the potential of neurostimulation technology to provide meaningful relief for those who have been suffering without adequate solutions.
What Comes Next
The LUNA study represents a comprehensive investigation into whether tAN can provide effective, accessible relief for heavy menstrual bleeding. Upon completion of the study, the findings will be submitted to the Food and Drug Administration (FDA), which serves as the gatekeeper for all medical devices in the United States. The FDA reviews clinical trial data to ensure devices are both safe and effective before companies can legally market them as treatments for specific medical conditions like heavy menstrual bleeding. If results demonstrate efficacy, this technology could offer a new pathway for managing heavy menstrual bleeding—one that doesn't require medication or surgery and can be integrated into daily life without disruption.
Looking Forward
Heavy menstrual bleeding can be isolating and debilitating. Whether you're experiencing HMB yourself or supporting someone who is, the LUNA study represents hope for better, more accessible treatment options. We're committed to advancing the science of women's health and will share updates as the study progresses.
OhmBody is a wellness device designed to support comfort and overall well-being during menstruation, including areas like mood, sleep, focus, energy, and digestion. It’s not a medical treatment. Always check in with a qualified healthcare provider about symptoms, diagnoses, or care decisions.
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