tAN to reduce heavy menstrual bleeding (LUNA)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Navid Khodaparast, PhD — Spark Biomedical, Inc.
• Study coordinator: Elizabeth Petsos
• Email: LUNA@lindushealth.com
• Phone: (844) 534-9716

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry to collect real-world data on the Cerene Cryotherapy Device

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• Progestin options for heavy periods in young people with inherited bleeding disorders

  This project will test two progestin menstrual treatments—a levonorgestrel IUD and daily norethindrone acetate—in adolescents and young adults (ages 10–24) with inherited bleeding disorders to see which better reduces heavy menstrual bleeding over six months.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.