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NCT03662308 · ClinicalTrials.gov registry record · NA
Heated Vest for Persons With Spinal Cord Injury
A NA study of Spinal Cord Injuries, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT03662308: Completed NA study of Spinal Cord Injuries, sponsored by VA Office of Research and Development.
NCT03662308 is a NA study of Spinal Cord Injuries that has completed, run by VA Office of Research and Development. The registered enrollment target is 17 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03662308, a NA study of Spinal Cord Injuries, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Tcore will be continuously monitored throughout baseline and thermal challenge periods (with heated \& non-heated vests) by a TX-2 Rectal probe and Iso-Thermex Multichannel Thermometer (Columbus Instruments, Columbus, OH). The probe will be placed 10 cm beyond the anal sphincter.
Conditions Studied
Interventions
- DEVICE Heated Vest
- DEVICE Non-Heated Vest
Study Locations (1)
New York
- James J. Peters VA Medical Center, Bronx, NY - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-02-25 |
| Est. Completion | 2022-10-31 |
| Phase | NA |
What the finished NCT03662308 record still lists
NCT03662308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Heated Vest is the first listed.
NCT03662308 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03662308 about?
NCT03662308 is a clinical study titled "Heated Vest for Persons With Spinal Cord Injury". 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 hypother...
What is the current status of trial NCT03662308?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2020-02-25. Estimated completion is 2022-10-31.
What conditions does trial NCT03662308 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT03662308?
The interventions under investigation include: Heated Vest (DEVICE), Non-Heated Vest (DEVICE).
Who is sponsoring clinical trial NCT03662308?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03662308 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03662308's enrollment target sits among peer trials
17 143rd of 202 higher than 59 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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