The LUNA Study: Sparrow Link for Heavy Menstrual Bleeding
The LUNA study is looking into whether a device called Sparrow Link can help reduce heavy menstrual bleeding (HMB). This study is for women aged 14 to 45 who experience HMB without a known structural cause. The Sparrow Link is a wearable device that gently stimulates nerves around the ear. Some participants will receive the active stimulation, while others will receive a sham (inactive) device that looks the same. The main goal is to see if the Sparrow Link reduces the amount of bleeding, which will be measured daily using a Pictorial Bleeding Assessment Chart (PBAC) over five menstrual cycles. This study is conducted remotely, meaning you can participate from home, and it will not interfere with your current non-hormonal HMB treatments.
- Study design
- This is a randomized, double-blind, sham-controlled study, meaning participants are randomly assigned to receive either the active device or a look-alike inactive device, and neither you nor the researchers will know which you are receiving. It plans to enroll 80 participants.
- What's involved
- You would participate over five consecutive menstrual cycles, which is estimated to be about 150 days. All study activities will happen remotely.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your bleeding will be measured daily throughout all five menstrual cycles, for an estimated 150 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Delivering tAN to Reduce HMB: The LUNA Study
At a glance
Conditions
NCT07326722
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Lindus Health - DECENTRALIZED STUDY
Boston, Massachusettsstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Navid Khodaparast, PhD · PRINCIPAL_INVESTIGATOR · Spark Biomedical, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Pictorial Bleeding Assessment Chart (PBAC)Daily throughout all five menstruations (up to 5 complete menstrual cycles - estimated 150 days)
The PBAC is a widely accepted tool for patients with HMB to account for menstrual blood loss. Menstrual blood loss is estimated through a selection of images of tampons, pads, clots, and flooding events. Users mark a tally next to the images that best match each the saturation level of the menstruation products they used that day. PBAC data will be recorded by the participants for each calendar day (00:00-23:59 local time). Day 1 is the calendar date on which a menstrual product is first used. This trial will utilize a modified version of the Higham PBAC, where a tally system will be added to each of the images.