A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

Stanford University

Status: Completed

Conditions: Postural Tachycardia Syndrome

Treatments: Device: Embr Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04943276

IRB-59863

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

23 participants in 1 patient group

Embr Watch

Experimental group

Description:

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

Treatment:

Device: Embr Device