Recruiting

tAN

Sponsor:

Texas Christian University

Code:

NCT07688720

Conditions

Perimenopause

PMDD

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

transcutaneous auricular neurostimulation (tAN)

Study Details

Brief 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, and following the intervention.

Conditions

Perimenopause

PMDD

Study ID

NCT07688720

Start date

Jun, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

PMS/PMDD Study:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Must not have any other mental illness or mood disorder

Perimenopause Study:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tAN treatment

For perimenopausal women: tAN administration 2 hours daily. For PMS/PMDD women: tAN administration 2 hours daily during the luteal phase.

Interventions

transcutaneous auricular neurostimulation (tAN)

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)

Primary outcome measure

  • Daily Record of Severity of Problems (DRSP) [ Time Frame: 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 [ Time Frame: Participants will complete this measure monthly from study initiation until the end of the study, about three months. ]

Central Contacts and Locations

Central contacts

Sarah E Hill, PhD

817-257-6424s.e.hill@tcu.edu

Savannah A Hastings, M.S.

817-257-4989s.a.hastings@tcu.edu

Locations

Texas Christian University

Recruiting

Fort Worth, Texas, United States, 76109

Contacts

Sarah E Hill, PhD

817-257-6424s.e.hill@tcu.edu

Savannah A Hastings, M.S.

8172574989s.a.hastings@tcu.edu

Principal Investigator:

Sarah E Hill, PhD

More Information

Sponsor

Texas Christian University

Last update posted

Jul 7, 2026

Last verified

Jun, 2026

Keywords

  • Premenstrual Symptoms
  • Menopause
  • Women's health
  • Perimenopause
  • Premenstrual Dysphoric Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Christian University on 2026-07-07.