A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

Study Overview
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Brief Summary
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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
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A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia

Conditions
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Postural Tachycardia Syndrome

Intervention / Treatment
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* Device: Embr Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embr Watch<br>Participants will receive the device and a technical onboarding video 3 days prior to study start to allow time for familiarization with the device and troubleshooting any technical questions or problems prior to study start. The study will consist of baseline measurements prior to using the Embr device and weekly outcome assessments at Week 1, 2, 3, and 4 | Device: Embr Device<br>* The Embr thermal device will be worn at all times from study start to the study endpoint.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline and end of study ( 4 weeks) | 
| Temperature Quality of life Questionnaire |  | Week 1,2,3,4 | 
| Temperature related daily interference scale | Scale range is 0-100, with a higher score indicating more problems with thermoregulation. | Week 1,2,3,4 | 
| OCEAN Temperature Related Psychogenic Questionnaire |  | Week 1,2,3,4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thermoregulation