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A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome
Trial ID: NCT04943276
Purpose
The investigators hope to learn the feasibility and preliminary efficacy of the Embr device
for improving thermal comfort in individuals with POTS and impaired thermoregulation.
Feasibility will be assessed via usage of the Embr device and participant feedback.
Preliminary efficacy measures will include temperature-related symptoms and temperature-
related quality of life in individuals with POTS and impaired thermoregulation.
Official Title
A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia
Stanford Investigator(s)
Mitchell Miglis, MD
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor, Psychiatry and Behavioral Sciences - Sleep Medicine
Eligibility
Inclusion Criteria:
- Diagnosis of POTS
- Participant self-report of heat or cold intolerance
- Willingness to wear the Embr device for 3 weeks, charging the device daily, and
- Have a working smartphone (iPhone 6 or greater; or Android 8.0 or greater
- Comfortable downloading and using the companion app on their phone
- Able to provide informed written consent
- Able to complete written questionnaires
Exclusion Criteria:
- Prior or current use of the study device
- Hypohidrosis, hyperhidrosis, or anhidrosis, as determined by sudomotor testing;
peripheral neuropathy; perimenopausal, menopausal, postmenopausal state; temperature
intolerance due to other medical disorders (i.e. malignancy, systemic autoimmune
disease)
- Medications known to affect sweat function
- Non-English speaking
Intervention(s):
device: Embr Device
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305