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

30 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Texas
      • Fort Worth, Texas, Verenigde Staten, 76109
        • Werving
        • Texas Christian University
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Sarah E Hill, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: tAN treatment
For perimenopausal women: tAN administration 2 hours daily. For PMS/PMDD women: tAN administration 2 hours daily during the luteal phase.
Apparaat: 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)

Andere namen:
  • Sparrow Link

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Daily Record of Severity of Problems (DRSP)
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Daily Mood
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Texas Christian University

Medewerkers

Spark Biomedical, Inc.

Onderzoekers

  • Hoofdonderzoeker: Sarah E Hill, PhD, Texas Christian University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 maart 2027

Studie voltooiing (Geschat)

1 maart 2027

Studieregistratiedata

Eerst ingediend

1 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 juni 2026

Eerst geplaatst (Werkelijk)

7 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

30 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB#2025-397

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Primary and secondary outcomes will be shared.

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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