Trial Outcomes & Findings for A Novel Cooling Vest to Protect Persons With SCI From Hyperthermia (NCT NCT05441449)

Last Updated: 2025-04-30

Results Overview

Tsk will be monitored using TX-4 Skin Surface probes and Iso-Thermex Multichannel Thermometer (Columbus Instruments, Columbus, OH). Skin thermocouples will be taped to 12 sites on the trunk (chest/abdomen) of AB controls (6 on each side) and on 10 sites on the chest/abdomen (5 on each side) and 4 sites on the bilateral hands and feet (2 on each side) for a total of 14 sites on persons with Hi-SCI determine change and minimum skin temperatures beneath the cooling vest

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Baseline (0 min) and end of thermal challenge (120 min) will be compared

Results posted on

2025-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Able-bodied (AB) Cooling Vest Testing Phase 1: After satisfying bench testing criteria, AB participants will wear the wet cooling vest at maximal settings for 2 hours in the seated position in a warm thermal chamber (35°C), to determine: (1) minimum skin temperatures beneath the cooling vest and (2) subjective thermal sensation of their skin beneath the cooling vest. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 2: Spinal Cord Injury (SCI) No Vest Day, Then Cooling Vest Day Phase 2: Participants with Hi-SCI will wear no vest (control condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position to determine (1) change in Tcore and (2) perception of heat and thermal comfort. Participants with Hi-SCI will then wear the wet vest on a separate day (experimental condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position to determine (1) change in Tcore and (2) perception of heat and thermal comfort. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.
Overall Study STARTED	5	10
Overall Study COMPLETED	5	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Novel Cooling Vest to Protect Persons With SCI From Hyperthermia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Able-bodied (AB) Cooling Vest Testing n=5 Participants Phase 1: After satisfying bench testing criteria, AB participants will wear the wet cooling vest at maximal settings for 2 hours in the seated position in a warm thermal chamber (35°C), to determine: (1) minimum skin temperatures beneath the cooling vest and (2) subjective thermal sensation of their skin beneath the cooling vest. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 2: Spinal Cord Injury (SCI) No Vest Day, Then Cooling Vest Day n=10 Participants Phase 2: Participants with Hi-SCI will wear no vest (control condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position to determine (1) change in Tcore and (2) perception of heat and thermal comfort. Participants with Hi-SCI will then wear the wet vest on a separate day (experimental condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position to determine (1) change in Tcore and (2) perception of heat and thermal comfort. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	37 years STANDARD_DEVIATION 15.5 • n=5 Participants	42 years STANDARD_DEVIATION 16.2 • n=7 Participants	40 years STANDARD_DEVIATION 16.1 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Body Mass Index (BMI)	25 kg/(m^2) STANDARD_DEVIATION 1.3 • n=5 Participants	21 kg/(m^2) STANDARD_DEVIATION 3.6 • n=7 Participants	23 kg/(m^2) STANDARD_DEVIATION 3.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (0 min) and end of thermal challenge (120 min) will be compared

Population: Within-group differences in the change for the average of all Skin Temperature (Tsk) from Baseline to post warm thermal chamber (35°C) for up to 2 hours were analyzed using a Repeated Measures ANOVA.

Outcome measures

Outcome measures
Measure	Arm 1: Cooling Vest n=5 Participants Phase 1: After satisfying bench testing criteria, AB participants will wear the wet cooling vest at maximal settings for 2 hours in the seated position in a warm thermal chamber (35°C), to determine: (1) minimum skin temperatures beneath the cooling vest and (2) subjective thermal sensation of their skin beneath the cooling vest. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 2: Cooling Vest n=10 Participants Phase 2: Participants with Hi-SCI will wear the wet vest (experimental condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 3: No Vest n=10 Participants Phase 2: Participants with Hi-SCI will wear no vest (control condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort.
Skin Temperature (Tsk) Change	-5.6 Degrees Celsius Standard Deviation 1.2	-6.9 Degrees Celsius Standard Deviation 2.7	2.1 Degrees Celsius Standard Deviation 1.1

PRIMARY outcome

Timeframe: Baseline (0 min) and end of thermal challenge (120 min) will be compared

Population: Within-group differences in the change for the Thermal Sensation from Baseline to post warm thermal chamber (35°C) for up to 2 hours were analyzed using a Repeated Measures ANOVA.

TS will be measured by a 9-point (+4 to -4) thermal sensation scale (+4 Very Hot. +3 Hot, +2 Warm, +1 Slightly Warm, 0 Neutral, -1 Slightly Cool, -2 Cool, -3 Cold, -4 Very Cold). During a thermal challenge, a subjective score of "0" (Neutral) would be preferred as it indicates thermoregulatory mechanisms are effective for the participant.

Outcome measures

Outcome measures
Measure	Arm 1: Cooling Vest n=5 Participants Phase 1: After satisfying bench testing criteria, AB participants will wear the wet cooling vest at maximal settings for 2 hours in the seated position in a warm thermal chamber (35°C), to determine: (1) minimum skin temperatures beneath the cooling vest and (2) subjective thermal sensation of their skin beneath the cooling vest. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 2: Cooling Vest n=10 Participants Phase 2: Participants with Hi-SCI will wear the wet vest (experimental condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 3: No Vest n=10 Participants Phase 2: Participants with Hi-SCI will wear no vest (control condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort.
Thermal Sensation (TS) Change	-2.1 score on a scale Standard Deviation 0.9	0.5 score on a scale Standard Deviation 1.2	2.6 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline (0 min) and end of thermal challenge (120 min) will be compared in persons with Hi-SCI

Population: Within-group differences in the change of core temperature (Tcore) from Baseline to post warm thermal chamber (35°C) for up to 2 hours were analyzed using a Repeated Measures ANOVA. Note: Tcore assessment was pre-specified to be collected only from participants with Hi-SCI. Therefore, these data were not collected from able-bodied participants.

Tcore: A disposable forehead skin temperature sensor (Bair HuggerTM Spot OnTM Temperature Monitoring System, 3M, Maplewood, Minnesota) will be placed on the frontal bone above the eyebrow on whatever side is most comfortable for the participant in order to measure core temperature (Tcore) in persons with Hi-SCI only. Less of an increase in Tcore is considered desirable during the thermal challenge.

Outcome measures

Outcome measures
Measure	Arm 1: Cooling Vest Phase 1: After satisfying bench testing criteria, AB participants will wear the wet cooling vest at maximal settings for 2 hours in the seated position in a warm thermal chamber (35°C), to determine: (1) minimum skin temperatures beneath the cooling vest and (2) subjective thermal sensation of their skin beneath the cooling vest. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 2: Cooling Vest n=10 Participants Phase 2: Participants with Hi-SCI will wear the wet vest (experimental condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 3: No Vest n=10 Participants Phase 2: Participants with Hi-SCI will wear no vest (control condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort.
Core Body Temperature (Tcore) Change	—	-0.1 degrees Celsius Standard Deviation 0.4	0.8 degrees Celsius Standard Deviation 0.4

SECONDARY outcome

Timeframe: Baseline (0 min) and end of thermal challenge (120 min) will be compared in persons with Hi-SCI

Population: Within-group differences in the change of Thermal Comfort from Baseline to post warm thermal chamber (35°C) for up to 2 hours were analyzed using a Repeated Measures ANOVA.

TC will be measured by a 6-point thermal comfort scale (+3 Very Comfortable, +2 Comfortable, +1 Just Comfortable, -1 Just Uncomfortable, -2 Uncomfortable, -3 Very Uncomfortable). Scores of +1, +2, and +3 scores are considered more desirable than -1, -2, and -3 scores during the thermal challenge.

Outcome measures

Outcome measures
Measure	Arm 1: Cooling Vest n=5 Participants Phase 1: After satisfying bench testing criteria, AB participants will wear the wet cooling vest at maximal settings for 2 hours in the seated position in a warm thermal chamber (35°C), to determine: (1) minimum skin temperatures beneath the cooling vest and (2) subjective thermal sensation of their skin beneath the cooling vest. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 2: Cooling Vest n=10 Participants Phase 2: Participants with Hi-SCI will wear the wet vest (experimental condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 3: No Vest n=10 Participants Phase 2: Participants with Hi-SCI will wear no vest (control condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort.
Thermal Comfort (TC) Change	0.4 score on a scale Standard Deviation 1.1	0.9 score on a scale Standard Deviation 0.4	0.8 score on a scale Standard Deviation 0.6

Adverse Events

Arm 1: Cooling Vest

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Cooling Vest

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm 3: No Vest

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1: Cooling Vest n=5 participants at risk Phase 1: After satisfying bench testing criteria, AB participants will wear the wet cooling vest at maximal settings for 2 hours in the seated position in a warm thermal chamber (35°C), to determine: (1) minimum skin temperatures beneath the cooling vest and (2) subjective thermal sensation of their skin beneath the cooling vest. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 2: Cooling Vest n=10 participants at risk Phase 2: Participants with Hi-SCI will wear the wet vest (experimental condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort. Cooling Vest: A self-regulating cooling vest for persons with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.	Arm 3: No Vest n=10 participants at risk Phase 2: Participants with Hi-SCI will wear no vest (control condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort.
Cardiac disorders Elevated Blood Pressure in Spinal Cord Injury Participant due to Accumulated Urine	0.00% 0/5 • Adverse events were reported within five business days to the VA's Institutional Review Board (IRB) via an Adverse Event form and were also included on the Adverse Events log on the annual continuing review application in accordance with VA IRB policy. Adverse event data were collected through study completion, up to three months.	10.0% 1/10 • Number of events 1 • Adverse events were reported within five business days to the VA's Institutional Review Board (IRB) via an Adverse Event form and were also included on the Adverse Events log on the annual continuing review application in accordance with VA IRB policy. Adverse event data were collected through study completion, up to three months.	0.00% 0/10 • Adverse events were reported within five business days to the VA's Institutional Review Board (IRB) via an Adverse Event form and were also included on the Adverse Events log on the annual continuing review application in accordance with VA IRB policy. Adverse event data were collected through study completion, up to three months.

Additional Information

Dr. John Handrakis

Spinal Cord Damage research Center, James J. Peters VA Medical Center

Phone: (718) 584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place