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

30. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • Texas
      • Fort Worth, Texas, Vereinigte Staaten, 76109
        • Rekrutierung
        • Texas Christian University
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Sarah E Hill, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: tAN treatment
For perimenopausal women: tAN administration 2 hours daily. For PMS/PMDD women: tAN administration 2 hours daily during the luteal phase.
Gerät: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Daily Record of Severity of Problems (DRSP)
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Daily Mood
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Texas Christian University

Mitarbeiter

Spark Biomedical, Inc.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Juni 2026

Zuerst gepostet (Tatsächlich)

7. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB#2025-397

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Primary and secondary outcomes will be shared.

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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