Study of Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding Randomized, Double-Blind, Sham-Controlled Trial in Females Aged 14 to 45

What this Trial Is About

Researchers are evaluating the use of transcutaneous auricular neurostimulation tAN in females aged 14 to 45 years who experience heavy menstrual bleeding HMB without a known structural cause. The LUNA study is a prospective, randomized, double-blind, sham-controlled clinical trial that includes two age groups adolescents 14-21 years and adults 22-45 years. It aims to assess the effects of tAN on menstrual bleeding and associated symptoms over five menstrual cycles. Participants will be randomly assigned to either an active tAN group or a sham placebo tAN group. The study begins with a two-cycle baseline phase M1-M2 without any treatment, during which participants track blood loss and menstrual pain daily. In the following three treatment cycles M3-M5, participants self-administer a daily 2-hour session of either active or sham tAN during menstruation. The active device stimulates nerves in the ear, while the sham device looks identical but delivers no stimulation. Throughout the study, participants will record daily blood loss using the Pictorial Bleeding Assessment Chart PBAC and pain levels with a Numerical Rating Scale NRS. Additional assessments include menstrual symptom severity, quality of life questionnaires, and device usability surveys. All activities take place remotely over approximately five menstrual cycles about 150 days. Participants continue their usual treatment for HMB as allowed and exit after completing the final treatment cycle.

Delivering tAN to Reduce HMB: The LUNA Study