Back to resultsA 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
About this trial
This is an interventional treatment trial for Postural Tachycardia Syndrome focused on measuring Thermoregulation
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
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
NCT ID
NCT04943276
First Posted
June 23, 2021
Last Updated
July 11, 2021
Sponsor
Stanford University
Collaborators
Embr Labs, Inc.
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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