A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia

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 Overview

• Status: Completed
• Conditions: Postural Tachycardia Syndrome
• Intervention / Treatment: Device: Embr Device

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Neuroscience Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Embr Device; The Embr thermal device will be worn at all times from study start to the study endpoint.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Embr Labs, Inc.
• Investigators: Principal Investigator: Mitchell Miglis, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2022
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): November 3, 2023

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Thermoregulation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Disease; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Syndrome; Tachycardia; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: IRB-59863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All individual participant data collected during the trial, after de-identification. Only this de-identified data will be shared with the Embr team.

PHI data will not be shared.

• IPD Sharing Time Frame: After study end. ( 1 Year after enrollment begins)
• IPD Sharing Access Criteria: Only Embr labs research team will have access to the de-identified data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No