A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

Not Applicable

Completed

• Conditions: Postural Tachycardia Syndrome
• Interventions: Device: Embr Device

• Registration Number: NCT04943276
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-29
• Study Start: 2022-02-27
• Primary Completion: 2023-11-03
• Study Completion: 2023-11-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embr Watch	Embr Device	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

Primary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Stanford Neuroscience Health Center; 🇺🇸 Stanford, California, United States