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OpenTrials
Completed

NCT Number: NCT04943276

A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

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.

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Key information

Conditions

Postural Tachycardia Syndrome Autonomic Nervous System Diseases Nervous System Diseases Orthostatic Intolerance Postural Orthostatic Tachycardia Syndrome Primary Dysautonomias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Neuroscience Health Center

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Embr Device

Device

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

Primary outcomes

  1. Change from baseline in Compass-31 survey at study endpoint

    Time frame: 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.

  2. Change from baseline in Pittsburg Sleep Quality Index (PSQI) at study endpoint

    Time frame: 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.

  3. Change from baseline in Insomnia Severity Scale Index (ISI) at study endpoint

    Time frame: Baseline and end of study ( 4 weeks)

    Scale range is 0-28, with 0 indicating absence of insomnia and 28 indicating severe insomnia.

  4. Temperature Quality of life Questionnaire

    Time frame: Week 1,2,3,4

  5. Temperature related daily interference scale

    Time frame: Week 1,2,3,4

    Scale range is 0-100, with a higher score indicating more problems with thermoregulation.

  6. OCEAN Temperature Related Psychogenic Questionnaire

    Time frame: Week 1,2,3,4

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Embr Labs, Inc.

Registry information

Official study title

A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 29, 2021
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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