Postural Tachycardia Syndrome
Conditions
Keywords
Thermoregulation
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.
Interventions
DEVICEEmbr Device
The Embr thermal device will be worn at all times from study start to the study endpoint.
Sponsors
Embr Labs, Inc.
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed