Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
30. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Podmínky
Intervence / Léčba
Detailní popis
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).
Typ studie
Intervenční
Zápis (Odhadovaný)
20
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Sarah E Hill, PhD
- Telefonní číslo: 817-257-6424
- E-mail: s.e.hill@tcu.edu
Studijní záloha kontaktů
- Jméno: Savannah A Hastings, M.S.
- Telefonní číslo: 817-257-4989
- E-mail: s.a.hastings@tcu.edu
Studijní místa
-
-
Texas
-
Fort Worth, Texas, Spojené státy, 76109
- Nábor
- Texas Christian University
-
Kontakt:
- Sarah E Hill, PhD
- Telefonní číslo: 817-257-6424
- E-mail: s.e.hill@tcu.edu
-
Kontakt:
- Savannah A Hastings, M.S.
- Telefonní číslo: 8172574989
- E-mail: s.a.hastings@tcu.edu
-
Vrchní vyšetřovatel:
- Sarah E Hill, PhD
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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)
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Daily Record of Severity of Problems (DRSP)
Časové okno: 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
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Daily Mood
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Sarah E Hill, PhD, Texas Christian University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
1. března 2027
Dokončení studie (Odhadovaný)
1. března 2027
Termíny zápisu do studia
První předloženo
1. června 2026
První předloženo, které splnilo kritéria kontroly kvality
30. června 2026
První zveřejněno (Aktuální)
7. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
7. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB#2025-397
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Primary and secondary outcomes will be shared.
Časový rámec sdílení IPD
The investigators will share data at the time of publication.
There will be no end date, data will be made available indefinitely.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .