PerimenopauseNCT07688720
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
A study testing transcutaneous auricular neurostimulation (tAN) in people with Perimenopause and PMDD, run by Texas Christian University at 1 site in United States.
Trial summary
Transcutaneous Auricular Neurostimulation (tAN) will be administered to women with premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and perimenopause. The investigators will examine whether tAN improves symptomology by collecting self-report data before the intervention, during the intervention… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Perimenopause, PMDD
- What is being tested?
- transcutaneous auricular neurostimulation (tAN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2026to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Assigned female at birth
- Age 18 to 45
- Naturally cycling
- Regularly occurring menstrual cycle
- Must identify as having PMS or PMDD
- Reliable ability to complete online study surveys
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- Assigned female at birth.
- Age 40 to 55
- Must have newly variable menstrual cycles or report identifying as perimenopausal
- Reliable ability to complete online study surveys
Who cannot join
- Using hormonal birth control
- Pregnant or lactating/breastfeeding
- History of seizures
- Implanted devices
- Current or previous diagnosis of any heart conditions
- Abnormal ear anatomy
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- Non-removable piercings on the ear
- Recent ear infection
- Taking SSRIs
- Taking steroids
- Taking hormone therapy
- If the participant anticipates starting or stopping prescription medications during the study period
- Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)
- Participant has a history traumatic brain injury within the past 12 months
- Must not have any other mental illness or mood disorder
- Perimenopause Study:
- Using hormonal birth control
- Pregnant or lactating/breastfeeding
- History of seizures
- Implanted devices
- Current or previous diagnosis of any heart conditions
- Abnormal ear anatomy
- Non-removable piercings on the ear
- Recent ear infection
- Taking SSRIs
- Taking steroids
- Taking hormone therapy
- If the participant anticipates starting or stopping prescription medications during the study period.
- Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)
- Participant has a history traumatic brain injury within the past 12 months
- have a hysterectomy
- In both studies we will confirm that participants are symptomatic shortly following enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Transcutaneous Auricular Neurostimulation (tAN) will be administered to women with premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and perimenopause. The investigators will examine whether tAN improves symptomology by collecting self-report data before the intervention, during the intervention, and following the intervention.
Read the detailed description
The PMS/PMDD study will last four menstrual cycles, for an average of four months in length. The first cycle will be baseline (pre-treatment), the next two cycles will be intervention (treatment), and one final cycle will be follow-up (post-treatment).
The perimenopause study will last three months. The first month will be baseline (pre-treatment), the next month will be intervention (treatment), and the final month will be follow-up (post-treatment).
- Conditions
- Perimenopause, PMDD
- Being tested
- transcutaneous auricular neurostimulation (tAN)
- Keywords
- Premenstrual Symptoms, Menopause, Women's health, Perimenopause, Premenstrual Dysphoric Disorder
- Medical subject headings
- Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular neurostimulation (tAN)Device
Also called Sparrow Link
Device: Sparrow Link. The Sparrow Link 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.
This device will stimulate the auriculotemporal nerve (ATN) and the auricular branch of the vagus nerve (ABVN)
| Study group | Role | What they receive |
|---|---|---|
| tAN treatment | Experimental | For perimenopausal women: tAN administration 2 hours daily. For PMS/PMDD women: tAN administration 2 hours daily during the luteal phase. Receives: Device: transcutaneous auricular neurostimulation (tAN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Record of Severity of Problems (DRSP)
The DRSP assesses psychological and physical premenstrual symptoms. This is the primary outcome in the PMS/PMDD study.
Measured: Assessed daily from study initiation until the end of the study, an average of four months (4 cycles). Menstrual cycle length varies but is generally 21-35 days.
Green Climacteric Scale
The Green Climacteric Scale assesses the degree to which respondents are bothered by a range of different menopausal symptoms. This is the primary outcome in the Perimenopause Study.
Measured: Participants will complete this measure monthly from study initiation until the end of the study, about three months.
Secondary outcomes (11)
Daily Mood
Each day, participants will be asked to respond to the question "How is your mood today?". Response options range from 1 = extremely bad/negative to 7 = extremely good/positive. This is a secondary outcome in both studies.
Measured: Participants will fill this out daily from study initiation until the end of the study, about 3 months in the perimenopause study and 4 months in the PMS/PMDD study (4 cycles). Menstrual cycle length varies but is generally 21-35 days.
Daily Hot Flash Frequency
Hot flash frequency will be assessed. This is a secondary outcome in the Perimenopause Study.
Measured: Participants will respond to questions about hot flash frequency daily from study initiation until the end of the study, about three months.
Daily Hot Flash Severity
Hot flash severity will be assessed. This is a secondary outcome in the Perimenopause Study.
Measured: Participants will respond to questions about hot flash severity daily from study initiation until the end of the study, about three months.
Daily Sleep Quality
Each day, participants will be asked to respond to the question, "How well did you sleep last night?". Response options range from 1 = Very poor to 5 = Excellent. This is a secondary outcome in the Perimenopause study.
Measured: Participants will respond to this question daily from study initiation until the end of the study, about three months.
Premenstrual Symptoms Screening Tool (PSST)
The PSST evaluates severity of premenstrual symptoms. This is a secondary outcome in the PMS/PMDD study.
Measured: Participants will complete this measure each cycle from study initiation until the end of the study, about four months (4 cycles). Menstrual cycle length varies but is generally 21-35 days.
Depression (PHQ-8)
Each cycle participants will complete the Patient Health Questionnaire-8 (PHQ-8) that assesses depression. In both studies this is a secondary outcome.
Measured: Participants will complete this measure each month/cycle from study initiation until the end of the study, about 3 months in the perimenopause study and 4 months in the PMS/PMDD study (4 cycles). Menstrual cycle length varies but is generally 21-35 days.
Anxiety (GAD-7)
Each cycle/month participants will complete the Generalized Anxiety Disorder-7 (GAD-7) scale that assesses anxiety symptoms. This is a secondary outcome in both studies.
Measured: Participants will complete this measure each cycle/month from study initiation until the end of the study, about 3 months in the perimenopause study and 4 months in the PMS/PMDD study (4 cycles). Menstrual cycle length varies but is generally 21-35 days.
Insomnia Severity Index (ISI)
Assesses sleep quality and sleep issues. This is a secondary outcome in both studies.
Measured: Participants will complete the ISI each cycle or monthly from study initiation until the end of the study, about 3 months in the perimenopause study and 4 months in the PMS/PMDD study (4 cycles). Menstrual cycle length varies but is generally 21-35 days.
Positive and Negative Affect Schedule (PANAS)
The PANAS is a self-report measure of a range of positive and negative emotions participants may be experiencing. This is a secondary outcome in both studies.
Measured: Participants will complete the PANAS each month/cycle from study initiation until the end of the study, about 3 months in the perimenopause study and 4 months in the PMS/PMDD study (4 cycles). Menstrual cycle length varies but is generally 21-35 days.
Menopause Quality of Life Questionnaire
The Menopause Quality of Life Questionnaire measures how frequently participants have been bothered by a range of different menopausal symptoms. This is a secondary outcome in the Perimenopause Study.
Measured: Participants will respond to this questionnaire monthly from study initiation until the end of the study, about three months.
Device Usability Questionnaire
Questionnaire designed to assess participants' overall satisfaction with the device and to evaluate how easily they were able to operate it using the provided instructions and support materials. This is a secondary outcome in both studies.
Measured: This will be administered at the end of the treatment period. Perimenopause study: this will be administered after month 2 (out of 3). PMS/PMDD study: this will be administered after cycle 3 (out of 4). Cycle length varies but is generally 21-35 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start22 Oct 2026
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Collaborators
- Spark Biomedical, Inc.
- Responsible party
- Principal investigator, Sarah Hill, Texas Christian University
- Investigators
- Sarah E Hill, PhD, Principal investigator, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688720
- Sponsor's protocol ID
- IRB#2025-397
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Primary and secondary outcomes will be shared.