Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2026-03-06
2027-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Sparrow Link
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.
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.
Sparrow Link (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.
Interventions
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Sparrow Link
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)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of menorrhagia as assessed by the Menorrhagia Screening Tool
3. 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
4. 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)
5. Willingness to consistently use only study-provided menstrual products throughout duration of the study
6. Participant PBAC scores are ≥150 for both baseline menstruation months
Exclusion Criteria
2. Lactating at the time of enrollment
3. Typical length of menstruation greater than 14 days
4. Antifibrinolytic (i.e. tranexamic acid; Lysteda) use within 14 days of enrollment
5. Known acquired bleeding disorder
6. Known severe bleeding disorder (participants with mild von Willebrand disease will be eligible to participate in the study)
7. Use of anticoagulants (i.e. Warfarin, Coumadin, etc.) including platelet inhibitors for 14 days prior to enrollment
8. Use of prescriptive pain medications and/or use of the following analgesics: Aspirin, naproxen (Aleve), or magnesium salicylate (Doan's) during the study
9. Use of the copper intrauterine device within the past three months
10. Structural cause of heavy menstrual bleeding (e.g. fibroids, polyps, etc.) in medical records
11. Documented thrombocytopenia within the last 12 months (platelet count ≤100,000 per microliter of blood) in medical records
12. Any use of continuous hormone therapies (e.g., IUD, etc.) within three months prior to enrollment
13. Use of hormone therapies that have not followed a standard 21/7 dosing regimen for at least six months prior to enrollment
14. 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
15. Participant has a history of epileptic seizures within the past 12 months
16. Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)
17. Participant has a history traumatic brain injury within the past 12 months
18. Participant has had a splenectomy
19. Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) and/or uses other neurostimulators
20. Participant has abnormal ear anatomy or ear infection present
21. Participant has previously used auricular neurostimulation for any clinical indication
22. Participant is currently or plans to be enrolled in another clinical trial during enrollment
23. Participant is a ward of the state
24. 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
14 Years
45 Years
FEMALE
No
Sponsors
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Lindus Health
INDUSTRY
Wellcome Leap
UNKNOWN
Oregon Health and Science University
OTHER
University of Michigan Health
UNKNOWN
Yale University
OTHER
Spark Biomedical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Navid Khodaparast, PhD
Role: PRINCIPAL_INVESTIGATOR
Spark Biomedical, Inc.
Locations
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Lindus Health - DECENTRALIZED STUDY
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Laura Mitchell
Role: primary
Other Identifiers
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5L-BLD-06
Identifier Type: -
Identifier Source: org_study_id
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