Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
30 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Interventistico
Iscrizione (Stimato)
20
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Sarah E Hill, PhD
- Numero di telefono: 817-257-6424
- Email: s.e.hill@tcu.edu
Backup dei contatti dello studio
- Nome: Savannah A Hastings, M.S.
- Numero di telefono: 817-257-4989
- Email: s.a.hastings@tcu.edu
Luoghi di studio
-
-
Texas
-
Fort Worth, Texas, Stati Uniti, 76109
- Reclutamento
- Texas Christian University
-
Contatto:
- Sarah E Hill, PhD
- Numero di telefono: 817-257-6424
- Email: s.e.hill@tcu.edu
-
Contatto:
- Savannah A Hastings, M.S.
- Numero di telefono: 8172574989
- Email: s.a.hastings@tcu.edu
-
Investigatore principale:
- Sarah E Hill, PhD
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: tAN treatment
For perimenopausal women: tAN administration 2 hours daily.
For PMS/PMDD women: tAN administration 2 hours daily during the luteal phase.
|
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)
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Daily Record of Severity of Problems (DRSP)
Lasso di tempo: 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
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Daily Mood
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Sarah E Hill, PhD, Texas Christian University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 giugno 2026
Completamento primario (Stimato)
1 marzo 2027
Completamento dello studio (Stimato)
1 marzo 2027
Date di iscrizione allo studio
Primo inviato
1 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
30 giugno 2026
Primo Inserito (Effettivo)
7 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB#2025-397
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Primary and secondary outcomes will be shared.
Periodo di condivisione IPD
The investigators will share data at the time of publication.
There will be no end date, data will be made available indefinitely.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .