CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
Heated Vest +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03662308
NCT03662308N/ACompleted

Developing a Feedback-Controlled Heated Vest to Address Thermoregulatory Dysfunction in Persons With Spinal Cord Injury

VA Office of Research and Development·interventional·Posted Sep 7, 2018·Updated May 6, 2024

In Brief

A clinical study evaluating Heated Vest and Non-Heated Vest for Spinal Cord Injuries. Completed, enrolled 17 participants across 1 site.

Detailed Summary

Persons with higher levels of spinal cord injury (above the 2nd thoracic vertebrae; tetraplegia) are unable to maintain normal core body temperature (Tcore) when exposed to cool environments. In persons with tetraplegia, even limited exposure to cool temperatures may cause Tcore to approach hypothermic values and impair cognitive performance. Conversely, an increase in Tcore from subnormal to normal range may improve cognitive performance. Prior work has shown that cool seasonal temperatures have an adverse effect on personal comfort and the ability to perform vital daily activities of self-care in persons with tetraplegia. Interventions that address the vulnerability to hypothermia are limited. A self-regulating heated vest designed specifically for persons with tetraplegia is a novel and promising strategy to address this problem. By more effectively maintaining Tcore, the vest can decrease the adverse impact of cool temperatures on comfort, quality of life, and performance of vital daily tasks for Veterans with tetraplegia during the cooler seasons.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 7, 2018
Enrollment StartFeb 25, 2020
Primary CompletionOct 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.8 years ago

Interventions

Heated Vestdevice

Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature

Non-Heated Vestdevice

A similarly insulated (compared to the experimental vest), but non-heated vest