Neurostimulation for Heavy Menstrual Bleeding
(LUNA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to manage heavy menstrual bleeding using a device that stimulates specific nerves in the ear, known as Transcutaneous Auricular Neurostimulation (tAN). The focus is on women and teens with heavy periods but no structural issues like fibroids. Participants will use either the actual nerve stimulation device or a non-active version that looks identical, allowing researchers to determine if the treatment truly makes a difference. To join, participants should regularly experience heavy periods and be willing to track their symptoms and use study-provided products. All activities occur remotely, so participants need a compatible device to complete surveys online. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options for heavy menstrual bleeding.
Will I have to stop taking my current medications?
You can continue taking your current non-hormonal medications and supplements if you've been using them consistently for the past three months, but you cannot start any new medications or homeopathic remedies during the study. However, you must stop using certain pain medications like aspirin, naproxen, and magnesium salicylate during the study.
What prior data suggests that this neurostimulation technique is safe for treating heavy menstrual bleeding?
Research shows that transcutaneous auricular neurostimulation (tAN) is generally safe. Previous studies with tAN found no major safety issues. Early research suggests this method is safe for reducing heavy menstrual bleeding. tAN has also been used successfully in other situations without major problems, indicating it might be well-tolerated for treating heavy menstrual bleeding too. However, as with any treatment, individual experiences can vary. Participants should always discuss any concerns with their healthcare provider.12345
Why are researchers excited about this trial?
Transcutaneous Auricular Neurostimulation (tAN) is unique because it offers a non-invasive way to manage heavy menstrual bleeding. Unlike standard treatments like hormonal therapies or surgical options, tAN uses a gentle electrical stimulation applied to the ear, potentially reducing symptoms without affecting the whole body. Researchers are excited because this approach may offer relief with fewer side effects, making it an attractive option for those seeking alternatives to medication or surgery.
What evidence suggests that transcutaneous auricular neurostimulation is effective for heavy menstrual bleeding?
This trial will compare active transcutaneous auricular neurostimulation (tAN) with a sham version to evaluate its effectiveness in reducing heavy menstrual bleeding. Studies have shown that tAN might help by stimulating nerves in the ear, influencing the body's control of blood flow and pain. Early research found that tAN reduced menstrual blood loss and shortened the period by about 19%. It also eased menstrual cramps and other related symptoms. These initial results suggest tAN could be a promising option for those dealing with heavy menstrual bleeding.12678
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
Citations
Transcutaneous auricular neurostimulation to reduce heavy ...
These pilot results suggest that tAN may be effective in reducing menstrual blood loss in HMB, including those with VWD using concomitant ...
Delivering tAN to Reduce HMB: The LUNA Study
The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy ...
HTRS2025.O8C.2 Delivering Transcutaneous Auricular ...
Fig 1: Transcutaneous auricular neurostimulation (tAN) reduces menstrual blood loss. Women (n=5) with von Willebrand disease and heavy menstrual bleeding ...
Transcutaneous auricular neurostimulation to reduce ...
These pilot results suggest that tAN may be effective in reducing menstrual blood loss in HMB, including those with VWD using concomitant ...
5.
ohsu.elsevierpure.com
ohsu.elsevierpure.com/en/publications/transcutaneous-auricular-neurostimulation-to-reduce-heavy-menstru/Transcutaneous auricular neurostimulation to reduce ...
Use of tAN also reduced duration of menstruation in both cohorts by 19%. Reductions in menstrual symptoms including cramp and other pain and ...
Hemostasis Using Transcutaneous Auricular ...
The preclinical data suggest a safe ... Transcutaneous auricular neurostimulation to reduce heavy menstrual bleeding in women with and without von Willebrand ...
Study Details | NCT06814028 | Transcutaneous Auricular ...
This study is designed as an open label, single-arm, decentralized research study in which patients with idiopathic heavy menstrual bleeding will receive ...
Effects of Transcutaneous Auricular Vagus Nerve ...
Risk factors for PD include age, obesity, smoking, nulliparity, early onset of menstruation, familial history, prolonged and heavy menstrual ...
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