A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

Trial ID or NCT#

NCT04943276

Status

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Mitchell Miglis, MD
Mitchell Miglis, MD
Autonomic disorders specialist, Sleep medicine specialist, General neurologist, Neurologist
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor, Psychiatry and Behavioral Sciences - Sleep Medicine

View on ClinicalTrials.gov