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NCT07326722 · ClinicalTrials.gov registry record · NA
Delivering tAN to Reduce HMB: The LUNA Study
A NA study, sponsored by Spark Biomedical.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT07326722 is a NA study that is actively recruiting participants, run by Spark Biomedical. The registered enrollment target is 80 participants.
The verdict
NCT07326722, a NA study, is actively recruiting participants, sponsored by Spark Biomedical.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), or sham stimulation. Participants will be enrolled into the study over the course of five consecutive menstrual cycles. All study activities will occur remotely and in addition to participants' typical treatment for HMB (as allowed by the eligibility criteria). During the first two consecutive menstrual cycles (M1 - M2, "Baseline Phase"), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC), and menstrual cramp pain will be assessed with a Numerical Rating Scale (NRS), daily throughout the duration of the menstruation phase of their two baseline menstrual cycles. 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 RAND Short-Form 36 (RAND-36). Menstrual-related quality of life assessments will also be conducted on the final day of each menstruation using the Menstrual Bleeding Questionnaire (MBQ) in the adult cohort, and the adolescent version (aMBQ) in the adolescent cohort. During the following three consecutive menstruations (M3 - M5, "Treatment Phase"), participants will self-administer one 2-hour sham or active tAN session daily, beginning Day 1 of menstruation through the final day of menstruation in each menstrual cycle. Blood loss (via the PBAC) and menstrual cramp pain (via the NRS) will be assessed daily throughout the duration of each menstruation. Quality of life will be assessed with
Interventions
- DEVICE Sparrow Link
- DEVICE Sparrow Link (Sham)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-03-06 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07326722
The ClinicalTrials.gov registry entry for NCT07326722 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spark Biomedical, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sparrow Link is the first listed.
NCT07326722 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07326722 about?
NCT07326722 is a clinical study titled "Delivering tAN to Reduce HMB: The LUNA Study". The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts wi...
What is the current status of trial NCT07326722?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2026-03-06. Estimated completion is 2027-08-31.
What interventions are being tested in trial NCT07326722?
The interventions under investigation include: Sparrow Link (DEVICE), Sparrow Link (Sham) (DEVICE).
Who is sponsoring clinical trial NCT07326722?
This trial is sponsored by Spark Biomedical, which has 13 total clinical trials registered on ClinicalTrials.gov.
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