Postural Tachycardia SyndromeNCT04943276
A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome
A study testing Embr Device in people with Postural Tachycardia Syndrome, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postural Tachycardia Syndrome
- What is being tested?
- Embr Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2022to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Neuroscience Health Center
Stanford, California, 94305
About this study
Official title: A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia
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.
- Conditions
- Postural Tachycardia Syndrome
- Being tested
- Embr Device
- Keywords
- Thermoregulation
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embr DeviceDevice
The Embr thermal device will be worn at all times from study start to the study endpoint.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Embr Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and end of study ( 4 weeks)
Temperature Quality of life Questionnaire
Measured: Week 1,2,3,4
Temperature related daily interference scale
Scale range is 0-100, with a higher score indicating more problems with thermoregulation.
Measured: Week 1,2,3,4
OCEAN Temperature Related Psychogenic Questionnaire
Measured: Week 1,2,3,4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start27 Feb 2022
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postural Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Embr Labs, Inc.
- Responsible party
- Principal investigator, Mitchell Miglis, Stanford University
- Investigators
- Mitchell Miglis, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943276
- Sponsor's protocol ID
- IRB-59863
- Status last verified
- Oct 2024
- First submitted
- 23 Jun 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41747483
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia
- ClinicalTrials.gov ID
- NCT04943276
- Acronym / sponsor ID
- IRB-59863
- Conditions
- Postural Tachycardia Syndrome
- Keywords
- Thermoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Embr Labs, Inc.
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embr Watch | Experimental | Device: Embr DeviceParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embr DeviceThe Embr thermal device will be worn at all times from study start to the study endpoint. | Device | Embr Watch |
Primary outcome
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.
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.
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.
Temperature Quality of life Questionnaire
Time frame: Week 1,2,3,4
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.
OCEAN Temperature Related Psychogenic Questionnaire
Time frame: Week 1,2,3,4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 41747483Miglis 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Miglis principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embr Device in people with Postural Tachycardia Syndrome, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Compass-31 survey at study endpoint (time frame: Baseline and end of study ( 4 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.