COMPLETED

Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial

Conditions

Heavy Menstrual Bleeding Neurostimulation Hemostasis Menstrual cycle Menstruation Blood loss PBAC Menorrhagia CMSS Transcutaneous Auricular Neurostimulation tAN

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is designed as an open label, single-arm, decentralized research study in which patients with idiopathic heavy menstrual bleeding will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled over the course of three menstruations: one baseline menstruation and two menstruations with added daily neurostimulation.

Official Title

Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial

Quick Facts

Study Start:2025-02-14

Study Completion:2025-09-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06814028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Locations (Sites)

Five Liters - DECENTRALIZED STUDY

Dallas, Texas, 75252

United States

Collaborators and Investigators

Sponsor: Spark Biomedical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-14

Study Completion Date2025-09-24

Study Record Updates

Study Start Date2025-02-14

Study Completion Date2025-09-24

Terms related to this study

Keywords Provided by Researchers

Neurostimulation
Hemostasis
Menstrual cycle
Menstruation
Blood loss
PBAC
Menorrhagia
CMSS
Transcutaneous Auricular Neurostimulation
tAN
Heavy menstrual bleeding

Additional Relevant MeSH Terms

Heavy Menstrual Bleeding