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临床试验/NCT04923971
NCT04923971已完成不适用

Safety and Performance Monitoring During Occupational Work II

University of Connecticut2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Change in Rectal Temperature

研究概览

简要总结

BHSAI is developing a computational system that provides early alerts of a rise and fall in core body temperature to help reduce the risk of thermal injury in the field and during training. The goal of the body temperature alerting system is to use it during rest, exercise in the heat and cold. Therefore, the primary purpose of this investigation is to validate a body temperature alerting system using physiological responses that occur during rest and exercise in different cold environments. Multiple cold ambient temperatures will be validated.

详细描述

This study will employ a randomized, cross-over design to assess the effect of three different cold ambient temperatures on skin temperature at peripheral regions, core temperature (rectal), metabolic heat production, hand dexterity measures at rest, and athletic performance assessment after rest in cold ambient temperatures. The three different trials for this study will include ambient temperatures at: A. 0°C (32°F), B. -10°C (14°F), and C. Surrogate -20°C (-10°C + 3 m/s wind speed [14°F + 6 mph]). This will be accomplished by use of a environmental chamber.

Participants will be assigned after medical clearance is granted. Visit specific information is described below, however, specific data collection protocols for dependent variables and procedures are included below the description of the study design. Participants will be asked to sign a photo/video release form to be used in research projects, scientific publications/conferences and for educational purposes. Participants may be videoed or photographed while exercising or resting in the environmental chamber.

During the 0°C (32°F) and -10°C (14°F) trials, participants will wear cold weather gear as described by BHSAI. All cold weather gear will be machine-washable, provided to the participants and properly fitted to each individual. Clothing will be kept in the laboratory, machine-washed by manufacturer recommendations. Participants will not be able to keep clothing used upon completion of the study. These trials will also have a wind speed of 1 m/s. For the surrogate -20°C (-4°F) experiment, ambient temperature will be -10°C (14°F) with wind speed approximately at 3 m/s (6 mph) to serve as an aggregate for -20°C (-4°F). Wind will not be facing the participant. Participants will wear all cold weather gear listed above with the exception of the microfleece cap and shell layer for hand (Figure 2). For all trials, participants will rest upright on a chair with feet above the ground and hands on the arms of the chair (exposed to air). The participant will remain seated for 120 minutes. For additional safety of the participants, the experiment will be terminated if the core body temperature falls below 35°C (95°F) and/or the skin temperature in any of the peripheral regions falls below 8°C (46°F). During the three testing sessions, the participants will wear a Samsung Gear S3 smartwatch on their non-dominant arm and a Polar chest strap. These devices would be paired with a Samsung Galaxy Note 4 smartphone that runs the 2B-Cool algorithm for core temperature estimation using data from the smartwatch. These devices will be used in conjunction with data from the rectal and skin temperature sensors to validate the sponsors' temperature prediction algorithm. All devices will be cleaned prior to and after participant use per manufacturer instructions. These devices would be provided by BHSAI to the University of Connecticut. During the three testing sessions, in addition to the BHSAI-provided devices, participants will wear thermistors to record the skin temperature (finger-tip and base of finger, hand dorsum, big toe, nose, cheek, ear tip, chin, and forehead and will privately insert a rectal thermometer 15 cm (~4-6 ins) beyond the anal sphincter to record the gold-standard core temperature.VO2 data will also be assessed to collect metabolic heat production. Hand dexterity will be assessed using the validated Purdue pegboard test.

During all three sessions, researchers will ensure that the smartwatch is placed approximately 1-inch proximal to the wrist and fits snuggly to ensure accurate heart-rate measurements. Researchers will also ensure that the devices are paired with the smartphone and the physiological variables are being recorded on the phone before commencement of the session. Since different devices will be used for measuring the physiological variables and the associated gold standard, researchers will record the starting time-stamp from the smartphone and the gold-standard recording computer to ensure time synchronization.

Following the 120-minute seated rest period, a performance battery will be utilized to assess athletic performance in 3 different cold environments. Agility/reaction time, power, muscular strength, sprint performance on a cycle ergometer, and 1-mile time trial on a motorized treadmill will be assessed. An environmental symptom questionnaire (ESQ) will be administered at the end of the performance battery prior to exiting the chamber. All trials will be approximately 3-4 hours each. Total participation in the study is approximately 12-14 hours of time for the participant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 28 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Males between the ages of 18-28 years
  • Have been cleared to participate by the medical monitor for this study
  • Must perform aerobic exercise for 150 minutes per week.

排除标准

  • Are a female
  • Have a history of adverse reaction to the cold environments, such as cold urticaria (i.e.
  • allergy to the cold) and/or Raynaud's phenomenon [disorder that causes decreased blood flow to peripheral body parts (e.g. fingers and toes)]
  • Identify any symptoms of COVID-19, which include:
  • Fever that exceeds 100.4F
  • New loss of smell and/or taste
  • Shortness of breath/difficulty breathing
  • Muscle pain
  • Sore throat
  • Tested positive for COVID-19 within the past 6 months.
  • Have a current musculoskeletal injury that would limit their physical activity or preclude the participant from walking, jogging, running, sprinting, or cutting.
  • Chronic health problems that affect your ability to thermoregulate (disorders affecting the liver, kidneys or the ability to sweat normally).
  • Other current illnesses at time of testing
  • History of cardiovascular, metabolic, chronic respiratory disease, peripheral arterial disease, or coagulopathy.
  • Currently taking a medication that is known to influence body temperature or blood flow (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs, aspirin, vasoactive medications)
  • Currently smoking (cigarettes, vaporizers, e-cigarettes)
  • Have a history of claustrophobia
  • Have a history of allergic reactions to medical tape
  • Hypothyroidism
  • History of or current eating disorder(s)

结局指标

主要结局

Change in Rectal Temperature

时间窗: Measured continuously during one, 120 min rest blocks and 1 20-30 min athletic performance test period.]

Rectal thermometer will be self-inserted by participant to assess core temperature

Change in Heart Rate

时间窗: Measured continuously during one, 120 min rest block and 1 20-30 min athletic performance test period.]

A heart rate monitor will be worn by participant throughout the rest period and performance battery protocol

Change in Mean Skin temperature

时间窗: Measured continuously during one, 120 min rest block and 1 20-30 min athletic performance test period.]

Prior to the start of the protocol, participants will be instrumented with 9-site (Biopac) and 4-site mean skin temperature (iButton) sensors. The Biopac skin temperature sensors will be placed on the finger-tip and base of finger, hand dorsum, big toe, nose, cheek, ear tip, chin, and forehead. The iButton skin temperature sensors will be placed on the chest, arm, thigh, and calf.

次要结局

  • Change in Perception of Fatigue(Every 5 minutes of the rest block (120 mins) and 1 athletic performance battery (20-30 mins))
  • Change in Rating of Perceived Exertion(Measured during 1 20-30 min athletic performance test period)
  • Change in Thermal Sensation(Every 5 minutes of the rest block (120 mins) and 1 athletic performance battery (20-30 mins))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas J Casa

Professor

University of Connecticut

研究点 (2)

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