A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

NCT04943276 | Completed

• 1 other identifier: IRB-59863
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postural Tachycardia Syndrome

Keywords

Thermoregulation

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Embr Watch

EXPERIMENTAL

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

Interventions

Embr Device DEVICE

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

Embr Watch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Embr Labs, Inc.: collaborator

Study Sites (1)

Stanford Neuroscience Health Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Mitchell Miglis

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Neurology and Neurological Sciences

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 29, 2021
• Study Start: February 27, 2022
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

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

Locations

US (1)