Clinical Trials Directory

Trials / Completed

CompletedNCT01890915

Body Temperature in Persons With Tetraplegia When Exposed to Heat

Core Temperature During Heat Exposure in Persons With Tetraplegia

Status
Completed
Phase
Study type
Observational
Enrollment
21 (actual)
Sponsor
James J. Peters Veterans Affairs Medical Center · Federal
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

The deleterious effects of hyperthermia are well appreciated in able-bodied persons. However, the consequences of impaired regulation of normal body temperature on cognitive performance of persons with tetraplegia is not known. This study will provide the preliminary findings necessary for future work to design and explore physical and medical interventions to improve temperature regulation in those with tetraplegia with the goal of improved clinical care, health, and quality of life. The proposed study consists of 1 visit during which 20 subjects (10 with tetraplegia, 10 controls) will be exposed to 81°F for 40 minutes and then 95° F for up to 2 hours. Physiological as well as psychological processes will be monitored in all subjects during the study for safety and to determine differences in responses to exposure to hot ambient temperatures

Detailed description

After a cervical spinal cord injury (SCI) the motor, sensory and autonomic deficits cause, among other detriments, a blunted ability to maintain a constant core temperature. Impaired thermoregulation leaves persons with tetraplegia more susceptible to hyperthermia than able-bodied persons (AB). There has been a paucity of work addressing the thermoregulatory responses of persons with SCI to hot ambient temperatures, and even less study addressing the effect of these temperatures on cognitive performance. The goals of this pilot study are: to improve our understanding of the thermoregulatory mechanisms of individuals with tetraplegia when exposed to heat and to determine the effect of impaired thermoregulatory mechanisms on cognitive performance during exposure to 35°C for up to 2 hours. In order to address our goals we have designed a study methodology which consists of comparing the physiological and psychological responses of the two study groups (tetraplegia versus AB controls) from thermoneutral (27°C) to hot (35°C) environments.

Conditions

Interventions

TypeNameDescription
OTHERHeat ExposureHeat exposure of 95 degrees F for up to 2 hours.

Timeline

Start date
2013-05-01
Primary completion
2015-10-01
Completion
2015-10-01
First posted
2013-07-02
Last updated
2016-03-03
Results posted
2016-03-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01890915. Inclusion in this directory is not an endorsement.