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

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство 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)

Первичные конечные точки

• Daily Record of Severity of Problems (DRSP) [Срок оценки: 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 [Срок оценки: Participants will complete this measure monthly from study initiation until the end of the study, about three months.]

Вторичные конечные точки (11)

• Daily Mood [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Participants will respond to this question daily from study initiation until the end of the study, about three months.]
• Premenstrual Symptoms Screening Tool (PSST) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Participants will respond to this questionnaire monthly from study initiation until the end of the study, about three months.]
• Device Usability Questionnaire [Срок оценки: 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.]

Критерии участия

PMS/PMDD Study:

Критерии включения

• 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

Критерии исключения

• 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:

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Texas Christian University — Fort Worth

Идентификаторы

NCT: NCT07688720 · IRB#2025-397

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗