Oxytocin on Cold Water Task Performance and Recovery

Evaluating Potential Benefits of Intranasal Oxytocin on Undersea Operator Training and Performance: Cold Water Task Performance and Recovery

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Cold water operators undergo an extensive and unique set of physical, physiological, and psychological stressors during a mission. In-water transit may exceed 6 hours submerged in cold water, on rebreathers, and in a confined space. During this lengthy transit, operators must maintain vigilance over navigation, vehicle, and life support controls while exposed to the risks of mixed gas or oxygen rebreather diving, alongside hypothermia, dehydration, undernutrition, and other factors that can significantly degrade operator performance. Once the team has reached target, they must be at peak cognitive and physical readiness as they carry out their mission objective. When the mission objective is complete, the operators undertake the lengthy return trip back to their deployed base. Optimized operator cognitive and physical performance is essential throughout all phases of a cold water mission, and safe and tolerable approach to optimizing warfighter performance and resilience will be key for future cold water operations.

Given the potential thermogenic and recovery effects or intranasal OT, we hypothesize that prophylactic OT administration, compared to placebo, will mitigate deficits in mission-relevant performance during and after cold water exposure. For this project we will utilize the ONR Cold Water Performance Task Battery, which was designed based on results from a task analysis combined with input from the cold water operator community. The task battery has been validated for its ability to induce changes in core and peripheral body temperature, manual dexterity, cognitive performance, and physical performance following cold water exposure. Our hypothesis will be tested via one specific aim enrolling N=24 18-39 y/o men by using a rigorous, double-blind, placebo- controlled, within-subjects randomized cross-over trial comparing 48 IU OT vs placebo (saline) in cold water performance and recovery.

Specific Aim 1. To investigate the impact of intranasal OT on cold water task performance and recovery using the ONR Cold Water Performance Task Battery, which includes cold water exposure; cognitive performance testing via oculometric assessment and the Defense Automated Neurobehavioral Assessment (DANA); and physical performance testing via a simulated ruck, ladder climb, and manual dexterity testing.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida
        • Contact:
      • Pensacola, Florida, United States, 32502
        • Florida Institute for Human and Machine Cognition
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin Nasal Spray
Single dose of intranasal oxytocin (48 IU) prior to testing protocol.
Intranasal treatment with oxytocin via nasal spray (48 IU per dose)
Other Names:
  • Oxytocin
Placebo Comparator: Placebo Nasal Spray
Single dose of intranasal treatment with placebo (identical to oxytocin nose spray minus the oxytocin)
Intranasal treatment with placebo via nasal spray
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive performance assessment score change (code substitution)
Time Frame: Within 3 hours post-treatment
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
Cognitive performance assessment score change (code substitution)
Time Frame: Within 3 hours post-treatment
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
Cognitive performance assessment score change (reaction time)
Time Frame: Within 3 hours post-treatment
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
Cognitive performance assessment score change (reaction time)
Time Frame: Within 3 hours post-treatment
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
Oculometric assessment score change (saccades)
Time Frame: Within 3 hours post-treatment
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
Oculometric assessment score change (blink rate)
Time Frame: Within 3 hours post-treatment
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
Oculometric assessment score change (blink duration)
Time Frame: Within 3 hours post-treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced rating of perceived exertion (RPE) during physical assessment post-cold water exposure
Time Frame: Within 3 hours post-treatment
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in grip strength in cold water
Time Frame: Within 3 hours post-treatment
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
Difference in manual dexterity (underwater knot untying) in cold water
Time Frame: Within 3 hours post-treatment
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
Difference in manual dexterity (underwater peg board assessment) in cold water
Time Frame: Within 3 hours post-treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marcas Bamman, Ph.D., Florida Institute for Human and Machine Cognition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2022

Primary Completion (Actual)

July 29, 2022

Study Completion (Actual)

July 29, 2022

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-2020-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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