Health TrialsbyHealthPanel

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

ConditionsPerimenopausePMDD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorTexas Christian University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Assigned female at birth

Age 18 to 45

Naturally cycling

Regularly occurring menstrual cycle

Disqualifiers

Using hormonal birth control

Pregnant or lactating/breastfeeding

History of seizures

Implanted devices

Trial design

Design model

Single group

Treatments tested in this trial

  • 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)

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: tAN treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.
2

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.

Time frame
Participants will complete this measure monthly from study initiation until the end of the study, about three months.

Secondary outcomes

1

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.

Time frame
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.
2

Daily Hot Flash Frequency

Hot flash frequency will be assessed. This is a secondary outcome in the Perimenopause Study.

Time frame
Participants will respond to questions about hot flash frequency daily from study initiation until the end of the study, about three months.
3

Daily Hot Flash Severity

Hot flash severity will be assessed. This is a secondary outcome in the Perimenopause Study.

Time frame
Participants will respond to questions about hot flash severity daily from study initiation until the end of the study, about three months.
4

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.

Time frame
Participants will respond to this question daily from study initiation until the end of the study, about three months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Texas Christian University

Lead sponsor

Spark Biomedical, Inc.

Collaborator

Source ClinicalTrials.gov
Apply now