Heavy Menstrual BleedingLUNANCT07326722
Delivering tAN to Reduce HMB: The LUNA Study
A study testing Sparrow Link in people with Heavy Menstrual Bleeding, run by Spark Biomedical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- Sparrow Link
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lindus Health - DECENTRALIZED STUDY
Boston, Massachusetts, 02111
Elizabeth Petsos, 844-534-9716, LUNA@lindushealth.com
Sophie Twelves, (844) 534-9716, LUNA@lindushealth.com
About this study
Official title: Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding: The LUNA Study
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 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 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
- Being tested
- Sparrow Link, Sparrow Link (Sham)
- 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
- Medical subject headings
- Menorrhagia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sparrow LinkDevice
Also called Transcutaneous Auricular Neurostimulation
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
Also called Transcutaneous Auricular Neurostimulation (Sham)
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sparrow Link (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days)
Secondary outcomes (6)
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.
Measured: Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)
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.
Measured: Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days)
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.
Measured: Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)
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.
Measured: Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)
Adolescent Menstrual Bleeding Questionnaire (aMBQ)
The aMBQ measures HMB-related quality of life in adolescents. The aMBQ is a 19-item self-reported scale that evaluates symptom burden and its effects on school attendance and performance, extracurricular and social activities, physical functioning, and emotional well-being, using Likert-type responses with higher scores indicating greater impact. The aMBQ will be used in this trial to measure the severity of the adolescent cohort's menstrual pain on the final day of each menstruation.
Measured: Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)
Device Usability Questionnaire
The Device Usability Questionnaire is a 16-item survey that includes both Likert-scale questions (ranging from Strongly Agree to Strongly Disagree) and open-ended free-text responses. It is designed to assess participants' overall satisfaction with the device and to evaluate how easily they were able to operate it using the provided instructions and support materials (Instruction for Use and Quick Start Guide).
Measured: Final day of Menstruation 3 and Menstruation 5 (estimated 10 days per menstruation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start6 Mar 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spark Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health, Wellcome Leap, Oregon Health and Science University, University of Michigan Health, Yale University
- Responsible party
- Sponsor
- Investigators
- Navid Khodaparast, PhD, Principal investigator, Spark Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326722
- Sponsor's protocol ID
- 5L-BLD-06
- Acronym
- LUNA
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding: The LUNA Study
- ClinicalTrials.gov ID
- NCT07326722
- Acronym / sponsor ID
- LUNA / 5L-BLD-06
- Conditions
- Heavy Menstrual Bleeding
- Keywords
- transcutaneous auricular neurostimulation, tAN, heavy menstrual bleeding, HMB, adolescent heavy menstrual bleeding, aHMB, neurostimulation, vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Spark Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health, Wellcome Leap, Oregon Health and Science University, University of Michigan Health, Yale University
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active tAN | Experimental | Device: Sparrow LinkIn the Treatment Phase (M3-M5), participants will self-administer one two-hour session of active transcutaneous auricular neurostimulation (tAN) each day of menstruation. |
| Sham tAN | Sham comparator | Device: Sparrow Link (Sham)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. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sparrow LinkAlso: Transcutaneous Auricular NeurostimulationThe 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. | Device | Active tAN |
| Sparrow Link (Sham)Also: Transcutaneous Auricular Neurostimulation (Sham)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. | Device | Sham tAN |
Primary outcome
Pictorial Bleeding Assessment Chart (PBAC)
Time frame: Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days)
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.
6 secondary outcomes
Cox Menstrual Symptom Severity Scale (CMSS)
Time frame: Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)
Numerical Rating Scale (NRS)
Time frame: Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days)
RAND Short Form-36 (RAND-36)
Time frame: Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)
Menstrual Bleeding Questionnaire (MBQ)
Time frame: Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)
Adolescent Menstrual Bleeding Questionnaire (aMBQ)
Time frame: Final day of each menstruation (up to 5 complete menstrual cycles - estimated 150 days)
Device Usability Questionnaire
Time frame: Final day of Menstruation 3 and Menstruation 5 (estimated 10 days per menstruation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Navid Khodaparast, PhD principal investigator
Spark Biomedical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sparrow Link in people with Heavy Menstrual Bleeding, run by Spark Biomedical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Petsos ((844) 534-9716, LUNA@lindushealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pictorial Bleeding Assessment Chart (PBAC) (time frame: Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.