A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

Stanford University23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postural Tachycardia Syndrome

Interventions

Embr DeviceDEVICE

The Embr thermal device will be worn at all times from study start to the study endpoint.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford Neuroscience Health Center

Stanford, California, United States

Outcomes

Primary Outcomes

Change from baseline in Compass-31 survey at study endpoint

Compass 31 score ranges in value from 0 to 100. A score of 0 indicates no autonomic symptoms, while more-severe autonomic symptoms correspond to higher values.

Time frame: Baseline and end of study ( 4 weeks)

Change from baseline in Pittsburg Sleep Quality Index (PSQI) at study endpoint

PSQI score ranges in value from 0 to 21. A score of 0 indicates no sleep difficulties, while more-severe sleep difficulties correspond to higher values.

Time frame: Baseline and end of study ( 4 weeks)

Change from baseline in Insomnia Severity Scale Index (ISI) at study endpoint

Scale range is 0-28, with 0 indicating absence of insomnia and 28 indicating severe insomnia.

Time frame: Baseline and end of study ( 4 weeks)

Temperature Quality of life Questionnaire

Time frame: Week 1,2,3,4

Temperature related daily interference scale

Scale range is 0-100, with a higher score indicating more problems with thermoregulation.

Time frame: Week 1,2,3,4

OCEAN Temperature Related Psychogenic Questionnaire

Time frame: Week 1,2,3,4

Data from ClinicalTrials.gov

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