Delivering tAN to Reduce HMB: The LUNA Study

NCT07326722 | Recruiting FDA Device

• 1 other identifier: 5L-BLD-06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heavy Menstrual Bleeding

Keywords

transcutaneous auricular neurostimulation; tAN; heavy menstrual bleeding; HMB; adolescent heavy menstrual bleeding; aHMB; neurostimulation; vagus nerve stimulation; hemostasis; menstruation; menstrual cycle; blood loss; PBAC; Menorrhagia

Outcome Measures

Primary Outcomes (1)

• Pictorial Bleeding Assessment Chart (PBAC)

  The PBAC is a widely accepted tool for patients with HMB to account for menstrual blood loss. Menstrual blood loss is estimated through a selection of images of tampons, pads, clots, and flooding events. Users mark a tally next to the images that best match each the saturation level of the menstruation products they used that day. PBAC data will be recorded by the participants for each calendar day (00:00-23:59 local time). Day 1 is the calendar date on which a menstrual product is first used. This trial will utilize a modified version of the Higham PBAC, where a tally system will be added to each of the images.

  Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days)

Secondary Outcomes (6)

• Cox Menstrual Symptom Severity Scale (CMSS)

  Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)

• Numerical Rating Scale (NRS)

  Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days)

• RAND Short Form-36 (RAND-36)

  Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)

• Menstrual Bleeding Questionnaire (MBQ)

  Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)

• Adolescent Menstrual Bleeding Questionnaire (aMBQ)

  Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)

Study Arms (2)

Active tAN

EXPERIMENTAL

In the Treatment Phase (M3-M5), participants will self-administer one two-hour session of active transcutaneous auricular neurostimulation (tAN) each day of menstruation.

Device: Sparrow Link

Sham tAN

SHAM COMPARATOR

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.

Device: Sparrow Link (Sham)

Interventions

Sparrow Link DEVICE

The Sparrow Link will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle.

Also known as: Transcutaneous Auricular Neurostimulation

Active tAN

Sparrow Link (Sham) DEVICE

Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. The sham device has an identical appearance to the active device.

Also known as: Transcutaneous Auricular Neurostimulation (Sham)

Sham tAN

Eligibility Criteria

• Age: 14 Years - 45 Years
• Gender Eligibility Details: Regularly menstruating females.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spark Biomedical, Inc.: lead
• Lindus Health: collaborator
• Yale University: collaborator
• Wellcome Leap: collaborator
• Oregon Health and Science University: collaborator
• University of Michigan Health: collaborator

Study Sites (1)

Lindus Health - DECENTRALIZED STUDY

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Menorrhagia; Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Navid Khodaparast, PhD

  Spark Biomedical, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Mitchell

CONTACT

(844) 534-9716; LUNA@lindushealth.com

Caroline Benner

CONTACT

(210) 624-8046; clinicaltrials@sparkbiomedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Principal Investigator, Co-Investigators, study coordinators, and biostatisticians will be blinded to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two stimulation groups (active tAN or sham tAN) in a 1:1 fashion such that each group will have 20 adult participants and 20 adolescent participants with complete data.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 8, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-06

Locations

US (1)