Ear-Zap device eases heavy periods in small trial
NCT ID NCT06814028
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a small device that stimulates nerves in the ear to treat heavy menstrual bleeding. Forty women used the device during two menstrual cycles, and researchers measured changes in blood loss, pain, and quality of life. The goal was to find the right dose and see if this drug-free approach could offer relief.
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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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40 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Sep 2025
- 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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18 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.
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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 participants between 18-45 years of age 2. History of menorrhagia as assessed by the Menorrhagia Screening Tool 3. Stable/consistent use of current 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 5. Willingness to consistently use the same brand of tampons and/or pads throughout duration of the study 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. Use of hormone therapy in the past three months 5. Antifibrinolytic use within 30 days of enrollment 6. Known inherited or acquired bleeding disorder 7. Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment 8. Use of the Copper intrauterine device within the past 3 months 9. Known structural cause of heavy menstrual bleeding 10. Use of menstrual cups or menstrual underwear as a method of menstrual blood collection 11. 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 12. Participant has received a blood transfusion within 30 days prior to study 13. Participant has a history of epileptic seizures 14. Participant has a history of neurologic diseases or traumatic brain injury 15. Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) 16. Participant has abnormal ear anatomy or ear infection present 17. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are 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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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.
Contacts and locations
Locations
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Five Liters - DECENTRALIZED STUDY
Dallas, Texas, 75252, United States
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Other studies related to the condition(s) this trial covers.
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