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| Name | Class |
|---|---|
| Spark Biomedical, Inc. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tAN treatment | Experimental | For perimenopausal women: tAN administration 2 hours daily. For PMS/PMDD women: tAN administration 2 hours daily during the luteal phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous auricular neurostimulation (tAN) | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Record of Severity of Problems (DRSP) | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Mood | 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. |
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PMS/PMDD Study:
Inclusion Criteria:
Exclusion Criteria:
Perimenopause Study:
Inclusion Criteria:
Exclusion Criteria:
In both studies we will confirm that participants are symptomatic shortly following enrollment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah E Hill, PhD | Contact | 817-257-6424 | s.e.hill@tcu.edu | |
| Savannah A Hastings, M.S. | Contact | 817-257-4989 | s.a.hastings@tcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah E Hill, PhD | Texas Christian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Christian University | Recruiting | Fort Worth | Texas | 76109 | United States |
Primary and secondary outcomes will be shared.
The investigators will share data at the time of publication. There will be no end date, data will be made available indefinitely.
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.
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| ID | Term |
|---|---|
| D065446 | Premenstrual Dysphoric Disorder |
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Daily Hot Flash Frequency | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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. |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |