Perimenopause, PMDD
Conditions
Keywords
Premenstrual Symptoms, Menopause, Women's health, Perimenopause, Premenstrual Dysphoric Disorder
Brief summary
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.
Detailed description
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).
Interventions
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)
Sponsors
Texas Christian University
Spark Biomedical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Record of Severity of Problems (DRSP) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | Hot flash frequency will be assessed. This is a secondary outcome in the Perimenopause Study. |
| 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. | Hot flash severity will be assessed. This is a secondary outcome in the Perimenopause Study. |
| Daily Sleep Quality | 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. |
| 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. | The PSST evaluates severity of premenstrual symptoms. This is a secondary outcome in the PMS/PMDD study. |
| 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. | Each cycle participants will complete the Patient Health Questionnaire-8 (PHQ-8) that assesses depression. In both studies this is a secondary outcome. |
| 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. | 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. |
| 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. | Assesses sleep quality and sleep issues. This is a secondary outcome in both studies. |
| 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. | 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. |
| Menopause Quality of Life Questionnaire | 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. |
| 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. | 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. |
Countries
United States
Contacts
CONTACTSarah E Hill, PhD
CONTACTSavannah A Hastings, M.S.
PRINCIPAL_INVESTIGATORSarah E Hill, PhD
Texas Christian University
Outcome results
None listed