Earpiece zaps nerves to lighten heavy periods
NCT ID NCT07326722
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a wearable earpiece that gently stimulates nerves around the ear to see if it can reduce heavy menstrual bleeding. Eighty women and teens aged 14-45 will use the device for two hours each day during their periods for three cycles. Half will get real stimulation, half a sham, and all will track blood loss and symptoms remotely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sparrow Link device (transcutaneous auricular neurostimulation)
- What this could lead to
- If it works, this could offer a drug-free, non-invasive option to reduce heavy menstrual bleeding and improve quality of life.
- What could go wrong
- This is an early-stage, sham-controlled trial with only 80 participants. The device may not reduce bleeding more than a placebo, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Regularly menstruating female aged 14-45 years at time of screening 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: 1. Pregnancy within three months of enrollment 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Lindus Health - DECENTRALIZED STUDY
RECRUITINGBoston, Massachusetts, 02111, United States
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