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Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause

30. juni 2026 opdateret af: Sarah Hill, Texas Christian University
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76109
        • Rekruttering
        • Texas Christian University
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Sarah E Hill, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: tAN treatment
For perimenopausal women: tAN administration 2 hours daily. For PMS/PMDD women: tAN administration 2 hours daily during the luteal phase.
Enhed: 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)

Andre navne:
  • Sparrow Link

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Daily Record of Severity of Problems (DRSP)
Tidsramme: 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.
The DRSP assesses psychological and physical premenstrual symptoms. This is the primary outcome in the PMS/PMDD study.
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
Tidsramme: Participants will complete this measure monthly from study initiation until the end of the study, about three months.
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.
Participants will complete this measure monthly from study initiation until the end of the study, about three months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Daily Mood
Tidsramme: 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.
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.
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
Tidsramme: Participants will respond to questions about hot flash frequency daily from study initiation until the end of the study, about three months.
Hot flash frequency will be assessed. This is a secondary outcome in the Perimenopause Study.
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
Tidsramme: Participants will respond to questions about hot flash severity daily from study initiation until the end of the study, about three months.
Hot flash severity will be assessed. This is a secondary outcome in the Perimenopause Study.
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
Tidsramme: Participants will respond to this question daily from study initiation until the end of the study, about three months.
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.
Participants will respond to this question daily from study initiation until the end of the study, about three months.
Premenstrual Symptoms Screening Tool (PSST)
Tidsramme: 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.
The PSST evaluates severity of premenstrual symptoms. This is a secondary outcome in the PMS/PMDD study.
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)
Tidsramme: 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.
Each cycle participants will complete the Patient Health Questionnaire-8 (PHQ-8) that assesses depression. In both studies this is a secondary outcome.
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)
Tidsramme: 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.
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.
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)
Tidsramme: 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.
Assesses sleep quality and sleep issues. This is a secondary outcome in both studies.
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)
Tidsramme: 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.
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.
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
Tidsramme: Participants will respond to this questionnaire monthly from study initiation until the end of the study, about three months.
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.
Participants will respond to this questionnaire monthly from study initiation until the end of the study, about three months.
Device Usability Questionnaire
Tidsramme: 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.
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.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Texas Christian University

Samarbejdspartnere

Spark Biomedical, Inc.

Efterforskere

  • Ledende efterforsker: Sarah E Hill, PhD, Texas Christian University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB#2025-397

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Primary and secondary outcomes will be shared.

IPD-delingstidsramme

The investigators will share data at the time of publication. There will be no end date, data will be made available indefinitely.

IPD-delingsadgangskriterier

The investigators will post the deidentified data on open science framework, meaning that it will be publicly available for any researchers who wish to download it.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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