NCT07326722 · Spark Biomedical, Inc.
Delivering tAN to Reduce HMB: The LUNA Study
(LUNA)
What this study is about
The LUNA study is a forward-looking, randomly assigned, where neither patients nor doctors know which treatment is given, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45.
View original scientific description
The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), or sham stimulation. Participants will be enrolled into the study over the course of five consecutive menstrual cycles. All study activities will occur remotely and in addition to participants' typical treatment for HMB (as allowed by the eligibility criteria). During the first two consecutive menstrual cycles (M1 - M2, "Baseline Phase"), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC), and menstrual cramp pain will be assessed with a Numerical Rating Scale (NRS), daily throughout the duration of the menstruation phase of their two baseline menstrual cycles. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the RAND Short-Form 36 (RAND-36). Menstrual-related quality of life assessments will also be conducted on the final day of each menstruation using the Menstrual Bleeding Questionnaire (MBQ) in the adult cohort, and the adolescent version (aMBQ) in the adolescent cohort. During the following three consecutive menstruations (M3 - M5, "Treatment Phase"), participants will self-administer one 2-hour sham or active tAN session daily, beginning Day 1 of menstruation through the final day of menstruation in each menstrual cycle. Blood loss (via the PBAC) and menstrual cramp pain (via the NRS) will be assessed daily throughout the duration of each menstruation. Quality of life will be assessed with the CMSS, RAND-36, and the MBQ (adults) or aMBQ (adolescents) on the final day of each menstruation. A device usability survey will be completed at the end of M3 and M5. Participants will exit the study after the final day of M5.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Regularly menstruating female aged 14-45 years at time of screening
- History of menorrhagia as assessed by the Menorrhagia Screening Tool
- 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
- 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)
- Willingness to consistently use only study-provided menstrual products throughout duration of the study
- Participant PBAC scores are ≥150 for both baseline menstruation months
Exclusion criteria
- Pregnancy within three months of enrollment
- Lactating at the time of enrollment
- Typical length of menstruation greater than 14 days
- Antifibrinolytic (i.e. tranexamic acid; Lysteda) use within 14 days of enrollment
- Known acquired bleeding disorder
- Known severe bleeding disorder (participants with mild von Willebrand disease will be eligible to participate in the study)
- Use of anticoagulants (i.e. Warfarin, Coumadin, etc.) including platelet inhibitors for 14 days prior to enrollment
- Use of prescriptive pain medications and/or use of the following analgesics: Aspirin, naproxen (Aleve), or magnesium salicylate (Doan's) during the study
- Use of the copper intrauterine device within the past three months
- Structural cause of heavy menstrual bleeding (e.g. fibroids, polyps, etc.) in medical records
- Documented thrombocytopenia within the last 12 months (platelet count ≤100,000 per microliter of blood) in medical records
- Any use of continuous hormone therapies (e.g., IUD, etc.) within three months prior to enrollment
- Use of hormone therapies that have not followed a standard 21/7 dosing regimen for at least six months prior to enrollment
- 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
- Participant has a history of epileptic seizures within the past 12 months
- Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)
- Participant has a history traumatic brain injury within the past 12 months
- Participant has had a splenectomy
- Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) and/or uses other neurostimulators
- Participant has abnormal ear anatomy or ear infection present
- Participant has previously used auricular neurostimulation for any clinical indication
- Participant is currently or plans to be enrolled in another clinical trial during enrollment
- Participant is a ward of the state
- 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
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations