Join the LUNA Study: Help test a new approach for easing symptoms of heavy menstrual bleeding, from home

Enrolling women ages 14-45 with heavy menstrual bleeding for research using a wearable investigational medical device to help reduce uncomfortable menstrual symptoms. Seeking women 14-45 with heavy periods of no known structural cause. After a 2-month baseline, wear the investigational device during periods at home for 3 months, complete brief daily surveys, with compensation up to $400 for your time and pads/tampons provided for the duration of the study.

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Study overview

Your Participation

At home:

  • Complete daily surveys for up to 5 menstrual cycles via phone, tablet or computer. Wear an investigational non-invasive device for up to 3 menstrual cycles for 2 hours at a time each day.

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Compensation

Participants can receive up to $400 for completing all study visits. Tampons and pads will be provided to you at no cost during your enrollment.

Timeline

Currently enrolling up to 88 participants across the U.S. The total study duration is about 5 months.

Study Location

From home virtually across continental US

Health Insights: Watch & Learn

Next Steps

Pre-screening and Book video call with our team

Complete a brief online questionnaire to assess initial eligibility (5 minutes). If you pass this stage you will receive study information via email to read. Book a video call to speak with our study team to consent, confirm eligibility and review study details (30 minutes). To reduce the length of the call by having the following items on hand at the start of the call: -Proof of Identification (current driver’s license or passport)

Medical Record Retrieval

This will be discussed during the screening visit. You will have the option to upload a portion of your medical records to a secure portal or sign a medical record retrieval consent form allowing the study team to request the relevant records to confirm heavy menstrual bleeding with no known cause.

Baseline & Randomization

For your first two consecutive menstrual cycles you will be asked to complete daily questionnaires on each day of your cycle. The study team will then assess if you are eligible for the treatment part of the study.

Enrollment & Treatment

The study period covers three consecutive menstrual cycles. All required supplies, including the device, are shipped to your home. You will also be asked to schedule a training call with the Device Specialist that will take about an hour to learn how to use the device. Complete brief daily questionnaires on your phone or device each day. Check in with the study team via a video call for about 15 minutes after your third cycle.

Complete study participation

At the end of the study you will complete some final questionnaires, providing your feedback about the device and receive instructions on sending back the study device. You will also meet with the study team to complete a study exit interview in 15-20 minutes to review feedback on your experience with the device.

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Patient Stories

Robert

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"The cardiovascular clinical trial I participated in provided me with access to the latest treatments before they became widely available. The through screening process and ongoing support gave me confidence in the study."

Maria

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"Joining this crinical trial for my autoimmune condition was life-changing. The research team's expertise and dedication were evident from day one. I received personalized care and monitoring that exceeded my expectations."

David

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"The migraine study I participated in provided me with access to innovative treatments that significantly reduced my symptoms. The study coordinators were professional and made me feel comfortable throughout the process."

Robert

Cardiovascular Research Trial

"The cardiovascular clinical trial I participated in provided me with access to the latest treatments before they became widely available. The through screening process and ongoing support gave me confidence in the study."

Maria

Autoimmune Treatment Study

"Joining this crinical trial for my autoimmune condition was life-changing. The research team's expertise and dedication were evident from day one. I received personalized care and monitoring that exceeded my expectations."

David

Migraine Prevention Trial

"The migraine study I participated in provided me with access to innovative treatments that significantly reduced my symptoms. The study coordinators were professional and made me feel comfortable throughout the process."

Who is this study for?

You may be eligible if you meet the following requirements:
Gender
Female from birth
Age
14-45
History
Heavy menstrual bleeding with no known cause
Are 14-45 years old with a history of heavy menstrual bleeding with no known cause
Are pregnant, or were pregnant in the past 3 months.
Have periods longer than 14 days.
Use an Intrauterine Device (IUD)
Have a history of chronic tobacco use
Additional eligibility criteria will be reviewed during the screening process
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Think you might qualify? Complete a 2-minute questionnaire to check your eligibility.

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Your questions answered

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What is a clinical trial?

A clinical trial is a research study that helps develop and test new medical treatments, devices, or tests to determine if they are safe and effective. This study evaluates the effect of transcutaneous auricular neurostimulation on reducing menstrual blood loss in women and girls. The investigational study device is a small transcutaneous auricular neurostimulator  that stimulates nerves around your ear by delivering mild electrical stimulation through the skin. Your participation provides data to help evaluate the device.

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Who is Spark Biomedical Inc.?

Spark Biomedical Inc. is the sponsor of this study. Spark Biomedical is a medical device company, looking to provide safe, effective alternatives to traditional therapies in areas like women’s health. In this research, Spark Biomedical Inc. is evaluating the effect of transcutaneous auricular neurostimulation on reducing menstrual blood loss in women and girls.

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‍Who is Lindus Health?

Lindus Health is a contract research organization that manages clinical trials. The team coordinates study recruitment, site and virtual operations, and data collection, which may involve virtual enrollment, medical record collection, and survey completion.

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What is Heavy Menstrual Bleeding and why is this research important?

Heavy menstrual bleeding affects approximately 20% of women of reproductive age in the United States. Research in this area is essential to explore whether new approaches can help women better manage heavy menstrual bleeding symptoms and reduce the impact on their daily activities and well-being.

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What will happen to my data?

All online surveys for this study will be collected through a HIPAA-compliant vendor. All video call visits will take place using a HIPAA-compliant teleconference platform. We may publish the results of this research; however, we will keep your name and other identifying information confidential.

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How will my medical records be collected?

If 18 or older, when you enroll, you'll sign an authorization allowing the study team to request records from your healthcare provider(s). If 14-17, when enrolled, the caregiver will sign authorization allowing the study team to request records from your healthcare provider(s).

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Can I withdraw from the study?

Yes, at any time without penalty or effect on your medical care.