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

NCT ID: NCT06814028

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2025-09-24

Brief Summary

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.

Detailed Description

This study is designed as an open label, single arm, cross-over decentralized clinical 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) via the mastoid and the auriculotemporal nerve (ATN) anterior to the tragus. Participants will be enrolled into the study over the course of three consecutive menstrual cycles.

During the First Menstruation (baseline), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC) daily throughout the duration of the menstruation phase of their menstrual cycle. 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 Short-Form 36 (SF-36).

During the Second Menstruation, participants will self-administer two 1-hour active tAN sessions daily (once in the AM, once in the PM), beginning Day 1 of menstruation through the final day of menstruation. Blood loss will be assessed daily using the PBAC throughout the duration of menstruation. Quality of life will be assessed with the CMSS and SF-36 on the final day of menstruation.

During the Third Menstruation, participants will self-administer a single 2-hour active tAN session each day, beginning Day 1 of menstruation through the final day of menstruation. Blood loss will be assessed daily using the PBAC throughout the duration of menstruation. Quality of life will be assessed with the CMSS and SF-36 on the final day of menstruation.

In addition, a device satisfaction survey will be completed at the end of the study. Participants will exit the study after the final day of their third menstruation.

Conditions

Heavy Menstrual Bleeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heavy Menstrual Bleeding Patients

Participants with no known cause of HMB who are not on hormonal therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (2 one-hour active tAN sessions daily) followed by Third Menstruation (1 two-hour active tAN session daily).

Group Type: EXPERIMENTAL

Volta System

Intervention Type: DEVICE

The Volta System 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. During the Second and Third Menstruations, participants will self-administer daily active tAN sessions Volta System Device beginning Day 1 of menstruation through the final day of menstruation.

Interventions

Volta System

The Volta System 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. During the Second and Third Menstruations, participants will self-administer daily active tAN sessions Volta System Device beginning Day 1 of menstruation through the final day of menstruation.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Five Liters, Inc.

INDUSTRY

Sponsor Role: collaborator

Spark Biomedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Five Liters - DECENTRALIZED STUDY

Dallas, Texas, United States

Countries

United States

Other Identifiers

5L-BLD-07

Identifier Type: -

Identifier Source: org_study_id