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| Name | Class |
|---|---|
| Embr Labs, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embr Watch | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embr Device | Device | The Embr thermal device will be worn at all times from study start to the study endpoint. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and end of study ( 4 weeks) |
| 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. | Baseline and end of study ( 4 weeks) |
| 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. | Baseline and end of study ( 4 weeks) |
| Temperature Quality of life Questionnaire | Week 1,2,3,4 | |
| Temperature related daily interference scale | Scale range is 0-100, with a higher score indicating more problems with thermoregulation. | Week 1,2,3,4 |
| OCEAN Temperature Related Psychogenic Questionnaire | Week 1,2,3,4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Miglis | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Neuroscience Health Center | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41747483 | Derived | Miglis MG, Seliger J, Machnik JV, Shaik R, Larsen NW, Sinn DI. Use of a thermal comfort wearable improves temperature intolerance in patients with postural tachycardia syndrome. Auton Neurosci. 2026 Apr;264:103398. doi: 10.1016/j.autneu.2026.103398. Epub 2026 Feb 21. |
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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.
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After study end. ( 1 Year after enrollment begins)
Only Embr labs research team will have access to the de-identified data
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| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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