A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-27

Study Completion Date

2023-11-03

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.

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Detailed Description

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Conditions

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Postural Tachycardia Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Embr Watch

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

Group Type EXPERIMENTAL

Embr Device

Intervention Type DEVICE

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

Interventions

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Embr Device

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No