Delivering tAN to Reduce HMB: The LUNA Study
ConditionHeavy Menstrual Bleeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14-45
SponsorSpark Biomedical, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sparrow Link
DeviceThe 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)
DeviceParticipants 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Active tANExperimental treatment 1 intervention
Group B: Sham tANSham comparator 1 intervention
Trial outcomes
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.
Time frame
Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days)Secondary outcomes
1
Cox Menstrual Symptom Severity Scale (CMSS)
The CMSS measures menstrual distress and dysmenorrhea. The CMSS Severity subscale is an 18-item self-reported scale that measures severity of menstrual symptoms, including pain, nausea, emotions, etc. during menstruation. The CMSS will be used in this trial to retrospectively measure the frequency and severity of a participant's menstrual symptoms on the final day of each menstruation.
Time frame
Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)2
Numerical Rating Scale (NRS)
The NRS measures menstrual pain daily on a scale of 0 to 10, with zero representing no pain and 10 representing the worst pain imaginable. This is a commonly used scale in studies of dysmenorrhea and other gynecological pain conditions. The NRS will be used in this trial to measure the severity of a participant's menstrual pain on each day of each menstruation.
Time frame
Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days)3
RAND Short Form-36 (RAND-36)
The RAND-36 is a 36-item patient-reported questionnaire that assesses general quality of life. This questionnaire includes eight variables: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy and vitality, pain, and general perception of health. This questionnaire will be completed by the participant at the end of each menstruation.
Time frame
Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)4
Menstrual Bleeding Questionnaire (MBQ)
The MBQ measures the impact of heavy menstrual bleeding on health-related quality of life in adult women. The MBQ is a 20-item self-reported scale that evaluates the frequency and severity of menstrual symptoms and their effects on physical, social, and emotional functioning, daily activities, and overall well-being. Responses are captured on Likert-type scales, with higher scores indicating greater symptom burden and functional impairment. The MBQ will be used in this trial to measure the severity of the adult cohort's menstrual pain on the final day of each menstruation.
Time frame
Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Spark Biomedical, Inc.
Lead sponsor
Lindus Health
Collaborator
Wellcome Leap
Collaborator
Oregon Health and Science University
Collaborator
University of Michigan Health
Collaborator
Yale University
Collaborator
Source ClinicalTrials.gov