Trial Outcomes & Findings for Heated Vest for Persons With Spinal Cord Injury (NCT NCT03662308)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Visits 2 & 3 (subjects with tetraplegia only): Continuously throughout baseline & Thermal Challenge (2 hrs) periods. The change in Tcore from baseline to the end of Thermal Challenge will be determined.

Results posted on

2024-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Heated Vest Safety & Comfort (Able-bodied Subjects) Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Persons With Tetraplegia: Heated Vest First, Then Non-Heated Vest Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Then, the same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort.	Persons With Tetraplegia: Non-Heated Vest First, Then Heated Vest Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Then, the same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort.
First Intervention STARTED	8	5	4
First Intervention COMPLETED	8	5	4
First Intervention NOT COMPLETED	0	0	0
Second Intervention (Tetraplegia ONLY) STARTED	0	5	4
Second Intervention (Tetraplegia ONLY) COMPLETED	0	5	4
Second Intervention (Tetraplegia ONLY) NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heated Vest for Persons With Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Heated Vest Safety & Comfort (Able-bodied Subjects) n=8 Participants Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Phase 2: Persons With Tetraplegia n=9 Participants For Persons with Tetraplegia: Heated Vest First, then Non-Heated Vest Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Then, the same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. For Persons with Tetraplegia: Non-Heated Vest First, then Heated Vest The subjects underwent the same interventions, but in the opposite order. That is, subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized insulated, but non-heated vest (control condition), then with a an appropriately sized insulated, heated vest.	Total n=17 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	7 Participants n=5 Participants	8 Participants n=7 Participants	15 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	39.5 years STANDARD_DEVIATION 14.6 • n=5 Participants	44.33 years STANDARD_DEVIATION 14 • n=7 Participants	42.06 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (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	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
BMI	23.96 kg/(m^2) STANDARD_DEVIATION 2.8 • n=5 Participants	26.30 kg/(m^2) STANDARD_DEVIATION 3.2 • n=7 Participants	25.2 kg/(m^2) STANDARD_DEVIATION 3.3 • n=5 Participants

PRIMARY outcome

Timeframe: Visits 2 & 3 (subjects with tetraplegia only): Continuously throughout baseline & Thermal Challenge (2 hrs) periods. The change in Tcore from baseline to the end of Thermal Challenge will be determined.

Population: Tcore measurement was not performed in able-bodied participants.

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.

Outcome measures

Outcome measures
Measure	Heated Vest Safety & Comfort (Able-bodied Subjects) Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Heated Vest Efficacy (Persons With Tetraplegia) n=9 Participants Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Non-Heated Vest Control Condition (Persons With Tetraplegia) n=9 Participants The same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Non-Heated Vest: A similarly insulated (compared to the experimental vest), but non-heated vest
Change in Core Body Temperature (Tcore)	—	-0.22 Degrees Celsius Standard Deviation .34	-0.46 Degrees Celsius Standard Deviation 0.24

PRIMARY outcome

Timeframe: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined. Each WAIS is 10 min

Population: We did not administer the Wechsler Adult Intelligence Scale Test to able-bodied participants.

WAIS-IV Digit Span test has 3, 16-point sections (Forward, Backward, Sequence) and assesses attention, processing speed, and working memory. Cognitive battery is administered at BL, after Thermal Challenge (tetra only). Testing conditions are distraction-free. The Forward section has 16 numerical sequences of successive increasing length (each 1 point). Participant is read the numbers, then asked to repeat the test numbers in the same order. In Backward, participant is asked to repeat the numbers in reverse order. In Sequence portion, the participant is asked to repeat the numbers in ascending order. Sections add to a WAIS-IV Total Score of 48. The greater the score, the better the cognitive function. The minimum score, which would represent not being able to repeat even the first sequence of numbers, is 0. We report the difference in WAIS-IV score before and after the cold challenge. The more negative the difference, the more cognitive impairment after cold challenge.

Outcome measures

Outcome measures
Measure	Heated Vest Safety & Comfort (Able-bodied Subjects) Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Heated Vest Efficacy (Persons With Tetraplegia) n=9 Participants Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Non-Heated Vest Control Condition (Persons With Tetraplegia) n=9 Participants The same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Non-Heated Vest: A similarly insulated (compared to the experimental vest), but non-heated vest
Change in Cognitive Performance: WAIS-IV (Wechsler Adult Intelligence Scale-Fourth Edition)	—	-0.500 score on a scale Standard Error 0.707	-0.375 score on a scale Standard Error 0.460

PRIMARY outcome

Timeframe: Visits 2 & 3 tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined. Each assessment requires 6 min.

Population: We did not measure working memory in able bodied participants.

Delayed Recall section of the Montreal Cognitive Assessment (MoCA): Subjects will be asked to repeat 5 simple words immediately and then recall them after a 5-minute delay to assess working memory. In scoring the MoCA, one point is awarded for each of the five words. Thus, the score ranges from 0 (no words remembered) to 5 (all words remembered). A higher score represents a more intact delayed recall capacity. We administered the Delayed Recall of the MoCA before and after the cold challenge, in both the heated vest (powered) and non-heated vest control condition. The reported measure is the mean difference in MoCA Delayed Recall scores before and after the cold challenge. Here, a more negative number represents a greater degree of impairment in delayed recall (working memory) after the cold challenge.

Outcome measures

Outcome measures
Measure	Heated Vest Safety & Comfort (Able-bodied Subjects) Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Heated Vest Efficacy (Persons With Tetraplegia) n=9 Participants Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Non-Heated Vest Control Condition (Persons With Tetraplegia) n=9 Participants The same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Non-Heated Vest: A similarly insulated (compared to the experimental vest), but non-heated vest
Change in Cognitive Performance: Delayed Recall	—	-0.38 score on a scale Standard Deviation 0.74	-2.00 score on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined.

Population: We did not measure cognitive performance in able bodied participants.

Stroop Color and Word: Subjects will be asked to read words of colors, colors of fonts to assess attention and processing speed; color of fonts of words which describe conflicting colors to assess response inhibition (executive functioning). Each assessment is 4 min. The Stroop Test yields three scores. The Raw Word score is the number of words correctly completed on the Word page in 45 seconds. Similarly for Color, and Color-Word. For example, in the color-word section, a participant correctly identifying the color of 61 words, the score is 61. Greater scores reflects greater executive functioning. Zero is the minimum score, which corresponds to not being able to read any of the words of colors or colors of fonts. Each words of colors or color of fonts correctly identified in time confer 1 point. We report the difference in Word-Color before the cold challenge and after the cold challenge, for each intervention. Negative differences represent impaired executive function.

Outcome measures

Outcome measures
Measure	Heated Vest Safety & Comfort (Able-bodied Subjects) Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Heated Vest Efficacy (Persons With Tetraplegia) n=9 Participants Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Non-Heated Vest Control Condition (Persons With Tetraplegia) n=9 Participants The same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Non-Heated Vest: A similarly insulated (compared to the experimental vest), but non-heated vest
Change in Cognitive Performance: Stroop	—	-2.125 score on a scale Standard Error 1.302	-1.750 score on a scale Standard Error 1.590

SECONDARY outcome

Timeframe: Visits 1, 2, & 3 (all subjects): During baseline & every 10 minutes throughout Thermal Challenge (2 hrs). The change in TC from baseline to the end of Thermal Challenge will be determined.

Thermal Comfort will be measured every 10 minutes throughout BL and thermal challenge periods by the Zhang 6-point thermal comfort scale: +3 (very comfortable), +2 (comfortable), +1 (just comfortable), -1 (just uncomfortable), -2 (uncomfortable), and -3 (very uncomfortable). A greater frequency of +1, +2, and +3 scores are considered more desirable than -1, -2, and -3 scores during the Thermal Challenge. Each assessment requires only the time needed for the subject to respond (typically less than 10 seconds).

Outcome measures

Outcome measures
Measure	Heated Vest Safety & Comfort (Able-bodied Subjects) n=8 Participants Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Heated Vest Efficacy (Persons With Tetraplegia) n=9 Participants Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Non-Heated Vest Control Condition (Persons With Tetraplegia) n=9 Participants The same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Non-Heated Vest: A similarly insulated (compared to the experimental vest), but non-heated vest
Change in Thermal Comfort (TC)	0.031 score on a scale Standard Deviation .72	-1.04 score on a scale Standard Deviation 1.51	-0.96 score on a scale Standard Deviation 1.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Visits 2 & 3 (all subjects): Continuously throughout baseline (15 min) & Thermal Challenge (2 hrs) periods. The change in Tsk from baseline to the end of Thermal Challenge will be determined.

Skin thermocouples (TX-4 Skin Surface probes, Columbus Instruments, Columbus, OH) will be taped to 12 sites on the anterior trunk. Tsk data will be collected continuously throughout the baseline (BL) and Thermal Challenge periods. All areas under the vest will have skin temperatures less than or equal to 39 degrees C.

Outcome measures

Outcome measures
Measure	Heated Vest Safety & Comfort (Able-bodied Subjects) n=8 Participants Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Heated Vest Efficacy (Persons With Tetraplegia) n=9 Participants Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Non-Heated Vest Control Condition (Persons With Tetraplegia) n=9 Participants The same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Non-Heated Vest: A similarly insulated (compared to the experimental vest), but non-heated vest
Change in Skin Temperature (Tsk) Under the Heated Vest	3.79 Degrees Celcius Standard Deviation 1.26	4.64 Degrees Celcius Standard Deviation 1.20	0.77 Degrees Celcius Standard Deviation 0.42

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 1 (able-bodied subjects only): During baseline & every 10 minutes throughout Thermal Challenge (2 hrs). The change in TS from baseline to the end of Thermal Challenge will be determined.

Population: We did not collect Thermal Sensation in persons with tetraplegia; we only collected this outcome measure in able-bodied controls.

Thermal sensation will be measured on the Zhang 9-point Thermal Sensation scale: +4 (very hot), +3 (hot), +2 (warm), +1 (slightly warm), 0 (neutral), -1 (slightly cool), -2 (cool), -3 (cold), and -4 (very cold). TS should be no greater than "warm" this would include identification of "hot spots". Each assessment requires only the time needed for the subject to respond (typically less than 10 seconds).

Outcome measures

Outcome measures
Measure	Heated Vest Safety & Comfort (Able-bodied Subjects) n=8 Participants Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Heated Vest Efficacy (Persons With Tetraplegia) Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Heated Vest: Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature	Non-Heated Vest Control Condition (Persons With Tetraplegia) The same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort. Non-Heated Vest: A similarly insulated (compared to the experimental vest), but non-heated vest
Change in Thermal Sensation (TS)	0.59 units on a scale Standard Deviation 0.61	—	—

Adverse Events

Heated Vest Safety & Comfort (Able-bodied Subjects)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Heated Vest Efficacy (Persons With Tetraplegia)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Heated Vest Control Condition (Persons With Tetraplegia)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Handrakis

SPINAL CORD DAMAGE RESEARCH CENTER

Phone: 718.584.9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place