A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04943276

Collaborator

Embr Labs, Inc. (Industry)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postural Tachycardia Syndrome	Device: Embr Device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in Compass-31 survey at study endpoint [Baseline and end of study ( 4 weeks)]
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.
Change from baseline in Pittsburg Sleep Quality Index (PSQI) at study endpoint [Baseline and end of study ( 4 weeks)]
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.
Change from baseline in Insomnia Severity Scale Index (ISI) at study endpoint [Baseline and end of study ( 4 weeks)]
Scale range is 0-28, with 0 indicating absence of insomnia and 28 indicating severe insomnia.
Temperature Quality of life Questionnaire [Week 1,2,3,4]
Temperature related daily interference scale [Week 1,2,3,4]
Scale range is 0-100, with a higher score indicating more problems with thermoregulation.
OCEAN Temperature Related Psychogenic Questionnaire [Week 1,2,3,4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Stanford University
Embr Labs, Inc.

Investigators

Principal Investigator: Mitchell Miglis, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mitchell Miglis, Clinical Assistant Professor, Neurology and Neurological Sciences, Stanford University

ClinicalTrials.gov Identifier:

NCT04943276

Other Study ID Numbers:

IRB-59863

First Posted:

Jun 29, 2021

Last Update Posted:

Jul 16, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Mitchell Miglis, Clinical Assistant Professor, Neurology and Neurological Sciences, Stanford University

Thermoregulation

Additional relevant MeSH terms:

Postural Orthostatic Tachycardia Syndrome

Tachycardia

Syndrome

Study Results

No Results Posted as of Jul 16, 2021