Cold Exposure Clinical Trial
Official title:
Evaluating Potential Benefits of Intranasal Oxytocin on Undersea Operator Training and Performance: Cold Water Task Performance and Recovery
Verified date | February 2024 |
Source | Florida Institute for Human and Machine Cognition |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Naval Special Warfare (NSW) operators are exposed to a variety of extreme environmental conditions and intense physical demands. In addition to breathing high pressure gases at depth, prolonged cold water immersion and inadequate recovery from sustained physical exertion negatively impact individual and team performance. Biotechnologies that could mitigate the effects of cold as well as support physical recovery represent a significant unmet need for the NSW operational community. Oxytocin (OT) has a wide range of actions both locally in the brain and peripherally in the body including skeletal muscle. These peripheral effects can be mediated by classic ligand-receptor activation given the abundant expression of the oxytocin receptor in peripheral tissues, along with local expression of OT in peripheral tissues where it is likely to act in an autocrine manner. Exogenous OT via intranasal administration is FDA Investigational New Drug (IND)-approved and has been demonstrated as an easy and safe method to increase circulating OT concentrations that may augment actions on peripheral tissues.
Status | Completed |
Enrollment | 17 |
Est. completion date | July 29, 2022 |
Est. primary completion date | July 29, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: - Recreationally skilled swimmers Exclusion Criteria: - Smoking/vaping, a history of psychiatric disorders, safety requirements related to the oxytocin administration [hypersensitivity to oxytocin or vasopressin, history of hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, or psychogenic polydipsia, on vasoconstrictors such as desmopressin, pseudoephedrine, or antidiuretic medication, or anti-inflammatory drugs, or muscle relaxants, low sodium and high osmolality levels, excessive smoking, excessive drinking, and significant nasal pathology. |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
United States | Florida Institute for Human and Machine Cognition | Pensacola | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida Institute for Human and Machine Cognition | Office of Naval Research (ONR), University of Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference in grip strength in cold water | During and after cold water exposure, participants will complete a grip strength assessment through the use of a hand dynamometer. Measurements will be taken in Newtons. | Within 3 hours post-treatment | |
Other | Difference in manual dexterity (underwater knot untying) in cold water | During and after cold water exposure, participants will complete a timed underwater knot untying and peg board time trial. Measurement will be recorded in seconds. | Within 3 hours post-treatment | |
Other | Difference in manual dexterity (underwater peg board assessment) in cold water | During and after cold water exposure, participants will complete a timed underwater peg board assessment time trial. Measurement will be recorded in seconds. | Within 3 hours post-treatment | |
Primary | Cognitive performance assessment score change (code substitution) | Changes in code substitution scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in milliseconds for response time. | Within 3 hours post-treatment | |
Primary | Cognitive performance assessment score change (code substitution) | Changes in code substitution scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in number of correct or incorrect responses. | Within 3 hours post-treatment | |
Primary | Cognitive performance assessment score change (reaction time) | Changes in choice reaction time scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in milliseconds for response time. | Within 3 hours post-treatment | |
Primary | Cognitive performance assessment score change (reaction time) | Changes in choice reaction time scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in number of correct or incorrect responses. | Within 3 hours post-treatment | |
Primary | Oculometric assessment score change (saccades) | Altered ocular response as measured by the I-Portal Portable Assessment System (i-PAS). Saccades will be monitored and counted throughout the duration of the assessment. | Within 3 hours post-treatment | |
Primary | Oculometric assessment score change (blink rate) | Altered ocular response as measured by the I-Portal Portable Assessment System (i-PAS). Number of blinks will be counted through the course of the assessment. | Within 3 hours post-treatment | |
Primary | Oculometric assessment score change (blink duration) | Altered ocular response in blink duration as measured by the I-Portal Portable Assessment System (i-PAS). Blink duration will be measured in milliseconds. | Within 3 hours post-treatment | |
Secondary | Reduced rating of perceived exertion (RPE) during physical assessment post-cold water exposure | Participants will signal on the Borg (6-20) scale for whole body and lower body exertion following their exposure to cold water. Lower on the scale signal a lower level of perceived physical exertion. | Within 3 hours post-treatment |
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