tAN to reduce heavy menstrual bleeding (LUNA)

Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding: The LUNA Study

This trial tests whether transcutaneous auricular neurostimulation (tAN) can reduce heavy menstrual bleeding in people aged 14–45 with no known structural cause.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 14 Years to 45 Years
• Sex: Female
• Sponsor: Spark Biomedical, Inc. (Industry-sponsored)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07326722 on ClinicalTrials.gov

What this trial studies

The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized trial comparing active transcutaneous auricular neurostimulation (tAN) to a sham device in participants with heavy menstrual bleeding of no known structural cause. It enrolls two age cohorts (adolescents 14–21 and adults 22–45) and follows participants across five consecutive menstrual cycles, with the first two cycles serving as a baseline without tAN. tAN targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), while participants record menstrual blood loss with the Pictorial Blood Assessment Chart (PBAC) and pain using numeric rating scales via a study app. All study activities are conducted remotely and participants may continue permitted usual treatments during the trial.

Who should consider this trial

Good fit: Ideal participants are menstruating people aged 14–45 with non-structural heavy menstrual bleeding who have PBAC scores ≥150 in both baseline months, have stable use of non-hormonal medications, reliable access to a compatible internet-enabled device, and agree to use only study-provided menstrual products.

Not a fit: People with confirmed structural causes of bleeding, those who are pregnant or lactating, have menstruation longer than 14 days, recent antifibrinolytic use, or cannot use the required mobile device or study products are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, tAN could offer a non-drug, non-surgical at-home option to reduce menstrual blood loss and related pain.

How similar studies have performed: Auricular/vagus neurostimulation has shown benefits for pain and autonomic conditions in prior research, but using tAN specifically to reduce heavy menstrual bleeding is a novel application that has not been well studied.

Eligibility criteria

Inclusion Criteria:

1. Regularly menstruating female aged 14-45 years at time of screening
2. History of menorrhagia as assessed by the Menorrhagia Screening Tool
3. Stable/consistent use of current non-hormonal medications and supplements for the past three months, willingness to continue use for duration of study, and not start any new medications or homeopathic remedies
4. Reliable access to an internet-enabled device to complete required questionnaires that is compatible with the study application (iOS 18 and Android 15 or greater)
5. Willingness to consistently use only study-provided menstrual products throughout duration of the study
6. Participant PBAC scores are ≥150 for both baseline menstruation months

Exclusion Criteria:

1. Pregnancy within three months of enrollment
2. Lactating at the time of enrollment
3. Typical length of menstruation greater than 14 days
4. Antifibrinolytic (i.e. tranexamic acid; Lysteda) use within 14 days of enrollment
5. Known acquired bleeding disorder
6. Known severe bleeding disorder (participants with mild von Willebrand disease will be eligible to participate in the study)
7. Use of anticoagulants (i.e. Warfarin, Coumadin, etc.) including platelet inhibitors for 14 days prior to enrollment
8. Use of prescriptive pain medications and/or use of the following analgesics: Aspirin, naproxen (Aleve), or magnesium salicylate (Doan's) during the study
9. Use of the copper intrauterine device within the past three months
10. Structural cause of heavy menstrual bleeding (e.g. fibroids, polyps, etc.) in medical records
11. Documented thrombocytopenia within the last 12 months (platelet count ≤100,000 per microliter of blood) in medical records
12. Any use of continuous hormone therapies (e.g., IUD, etc.) within three months prior to enrollment
13. Use of hormone therapies that have not followed a standard 21/7 dosing regimen for at least six months prior to enrollment
14. Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months
15. Participant has a history of epileptic seizures within the past 12 months
16. Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)
17. Participant has a history traumatic brain injury within the past 12 months
18. Participant has had a splenectomy
19. Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) and/or uses other neurostimulators
20. Participant has abnormal ear anatomy or ear infection present
21. Participant has previously used auricular neurostimulation for any clinical indication
22. Participant is currently or plans to be enrolled in another clinical trial during enrollment
23. Participant is a ward of the state
24. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Where this trial is running

Boston, Massachusetts

• Lindus Health - DECENTRALIZED STUDY — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Navid Khodaparast, PhD — Spark Biomedical, Inc.
• Study coordinator: Laura Mitchell

Conditions Heavy Menstrual Bleeding; transcutaneous auricular neurostimulation; tAN; heavy menstrual bleeding; HMB; adolescent heavy menstrual bleeding; aHMB; neurostimulation