Delivering tAN to Reduce HMB: The LUNA Study

Conditions

• Heavy Menstrual Bleeding

Eligibility Criteria

Sex

FEMALE

Age

14 Years - 45 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Mar 6, 2026

Status verified

Jun 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Pictorial Bleeding Assessment Chart (PBAC) [ Time Frame: Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days) ]

Central Contacts

• Laura Mitchell
  (844) 534-9716
  [email protected]
• Caroline Benner
  (210) 624-8046
  [email protected]

Locations (1)

Find similar trials in Boston, MA

Related Studies

• Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
  Recruiting · Oregon Health and Science University · Palo Alto, California
• A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
  Recruiting · Channel Medsystems · West Orange, New Jersey
• Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)
  Recruiting · Rejoni Inc. · Phoenix, Arizona