Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Daily Record of Severity of Problems (DRSP)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Daily Record of Severity of Problems (DRSP)
时间窗: 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.
Green Climacteric Scale
时间窗: 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.
次要结局
- Daily Mood(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(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(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(Participants will respond to this question daily from study initiation until the end of the study, about three months.)
- Premenstrual Symptoms Screening Tool (PSST)(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)(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)(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)(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)(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(Participants will respond to this questionnaire monthly from study initiation until the end of the study, about three months.)
- Device Usability Questionnaire(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.)
研究者
Sarah Hill
Professor
Texas Christian University