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A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

Primary Purpose

Postural Tachycardia Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Embr Device
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postural Tachycardia Syndrome focused on measuring Thermoregulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Embr Watch

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    Temperature Quality of life Questionnaire
    Temperature related daily interference scale
    Scale range is 0-100, with a higher score indicating more problems with thermoregulation.
    OCEAN Temperature Related Psychogenic Questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    June 23, 2021
    Last Updated
    July 11, 2021
    Sponsor
    Stanford University
    Collaborators
    Embr Labs, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04943276
    Brief Title
    A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome
    Official Title
    A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    August 1, 2022 (Anticipated)
    Study Completion Date
    August 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University
    Collaborators
    Embr Labs, Inc.

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postural Tachycardia Syndrome
    Keywords
    Thermoregulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Embr Watch
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    Embr Device
    Intervention Description
    The Embr thermal device will be worn at all times from study start to the study endpoint.
    Primary Outcome Measure Information:
    Title
    Change from baseline in Compass-31 survey at study endpoint
    Description
    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.
    Time Frame
    Baseline and end of study ( 4 weeks)
    Title
    Change from baseline in Pittsburg Sleep Quality Index (PSQI) at study endpoint
    Description
    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.
    Time Frame
    Baseline and end of study ( 4 weeks)
    Title
    Change from baseline in Insomnia Severity Scale Index (ISI) at study endpoint
    Description
    Scale range is 0-28, with 0 indicating absence of insomnia and 28 indicating severe insomnia.
    Time Frame
    Baseline and end of study ( 4 weeks)
    Title
    Temperature Quality of life Questionnaire
    Time Frame
    Week 1,2,3,4
    Title
    Temperature related daily interference scale
    Description
    Scale range is 0-100, with a higher score indicating more problems with thermoregulation.
    Time Frame
    Week 1,2,3,4
    Title
    OCEAN Temperature Related Psychogenic Questionnaire
    Time Frame
    Week 1,2,3,4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mitchell Miglis
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

    Learn more about this trial

    A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

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