A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

Postural Tachycardia Syndrome Clinical Trial

Official title:

A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04943276
• Other study ID #: IRB-59863
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: July 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Preliminary efficacy measures will include temperature-related symptoms and temperature- related quality of life in individuals with POTS and impaired thermoregulation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Device:
• Embr Device
The Embr thermal device will be worn at all times from study start to the study endpoint.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Embr Labs, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Temperature Quality of life Questionnaire		Week 1,2,3,4
Primary	Temperature related daily interference scale	Scale range is 0-100, with a higher score indicating more problems with thermoregulation.	Week 1,2,3,4
Primary	OCEAN Temperature Related Psychogenic Questionnaire		Week 1,2,3,4