Treatment Trials

7 Clinical Trials for Various Conditions

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UNKNOWN
Acquiring and Targeting Heat Exposures Necessary for Action
Description

The purpose of this research study is to better understand ways that women and men differ physiologically, cognitively, physically, and cellularly to better prescribe helpful interventions that will prevent injury and risk of conditions like exertional heat illnesses or heatstroke. The main questions this project aims to answer are: 1. What is the relative stress contributing to performance differences between women and men during intense exercise in extremely hot and humid environments in response to exertional heat stress? 2. What is the relative contribution of responses in adipose tissue, cardiovascular tissue, gut microbiota, and musculoskeletal tissue on heat tolerance in women (vs. men) to exertional heat stress? 3. What is the impact of adding an antioxidant juice consumption regime and will it assist in enhancing performance during an acute bout of exercise-heat stress before and after heat acclimation? Subjects enrolled and approved for participation will perform: 1. a heat acclimation protocol which includes the completion of 5 days of prescribed exercise-heat exposure 2. two separate acute exercise-heat exposures for the assessment of thermotolerance and the investigation of potential enhancements in thermoregulatory performance that may occur after the completion of a 5-day heat acclimation protocol 3. a subset of subjects enrolled and approved for participation who opt in to antioxidant berry supplement consumption will either consume the active or placebo product throughout their participation.

COMPLETED
Effect of Heat Exposure on Cognition in Persons With Tetraplegia
Description

The ability to maintain normal body temperature (Tcore) is impaired in persons with tetraplegia: subnormal Tcore and vulnerability to hypothermia (\<95 F) have been documented in this population after exposure to even mild environmental temperatures. However, no work to date has addressed the effect of subnormal Tcore on cognitive performance in persons with tetraplegia despite studies with able-bodied (AB) individuals that have documented progressive decline in various aspects of cognitive performance associated with the magnitude of the depression in Tcore. The investigators' study will confirm and extend their initial observations in persons with higher cord lesions who have subnormal Tcore to show that cognitive performance will be improved by raising Tcore to euthermic levels. This improvement should be associated with greater function and independence, reintegration into society, and an improved quality of life. Specific Aims: During exposure to 95 F for up to 120 minutes in the seated position, the investigators' aims are: Primary Specific Aim: To determine if a modest rise in Tcore to euthermic levels has a positive effect on cognitive performance (attention, working memory, processing speed, and executive function) in persons with higher-level spinal cord injury (SCI). Primary Hypothesis: Based on the investigators' pilot data: (1) 80% of persons with SCI will demonstrate an increase of 1 F in Tcore, while none of the AB controls will demonstrate such an increase; (2) 80% of persons with SCI will have an improvement of at least one T-score in Stroop Interference scores (a validated measure of executive function), while none of the AB controls will demonstrate a change in cognitive performance. Secondary Specific Aim: To determine changes in: (1) The average of distal skin temperatures; (2) Sweat rate; and (3) Subjective rating of thermal sensitivity. Secondary Hypothesis: Persons with SCI will have less of a percent change in average distal skin temperatures and sweat rate, and will report blunted ratings of thermal sensitivity compared to that of AB controls.

COMPLETED
The Influence of Menthol Gel During Exercise With Heat
Description

The purpose of this study is to examine the human thermoregulatory impact of applying a commercially available menthol gel (BioFreeze) to the skin prior to moderate intensity walking under heated conditions. Experimental Visits will consist of 30 min of treadmill walking at a moderate pace (3.5 mph, 5% grade) under hot conditions (38°C, 60%RH) and will be randomized and counterbalanced for BioFreeze or a hypoallergenic gel (control) application. Gels will be applied to areas commonly exposed during outdoor activity in warm conditions (shoulder to wrist, mid thigh to ankle). Accordingly, participants will wear shorts and a tank top shirt during exercise. Core temperature, skin temperature, galvanic skin response, laser doppler blood flow, and heart rate will be continuously recorded throughout the exercise bout via an integrated analog to digital converter. Sweat will be collected during exercise using commercially available absorbent patches. Thermal sensation will be assessed throughout exercise via the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) thermal sensation likert scale (cold to hot). Lastly, nude body weight will be recorded pre and post exercise for sweat rate determination. The BioFreeze and control trials will be separated by a 7-14 day washout period.

COMPLETED
The Influence of Capsaicin Gel During Exercise Within the Heat
Description

The purpose of this study is to examine the human thermoregulatory impact of applying a commercially available capsaicin gel to the skin prior to moderate intensity walking under heated conditions. Experimental Visits will consist of 30 min of treadmill walking at a moderate pace (3.5 mph, 5% grade) under hot conditions (38°C, 60%RH) and will be randomized and counterbalanced for capsaicin gel or a hypoallergenic gel (control) application. Gels will be applied to areas commonly exposed during outdoor activity in warm conditions (shoulder to wrist, mid thigh to ankle). Accordingly, participants will wear shorts and a tank top shirt during exercise. Core temperature, skin temperature, galvanic skin response, laser doppler blood flow, and heart rate will be continuously recorded throughout the exercise bout via an integrated analog to digital converter. Sweat will be collected during exercise using commercially available absorbent patches. Thermal sensation will be assessed throughout exercise via the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) thermal sensation likert scale (cold to hot). Lastly, nude body weight will be recorded pre and post exercise for sweat rate determination. The capsaicin and control trials will be separated by a 7-14 day washout period

COMPLETED
The Effect of AMP Human Sodium Bicarbonate Lotion on Hydration
Description

The purpose of this research study is to evaluate the effects of a topical sodium bicarbonate lotion on physiological and psychological responses associated with hydration status and fluid balance in humans during passive heat stress. Currently, the ingestion of sodium has been an effective measure for improvements in fluid regulation and hydration status in humans. However, the investigators do not know its regulatory relationship with measurements of fluid balance when supplemented through the skin.

RECRUITING
Implementing an Intervention to Reduce Heat Stress and Chemical Exposures
Description

The investigators are studying the dangers that farmworkers face while working in the fields and at home. The investigators goals are: 1. Measure how much heat and chemicals farmworkers in Imperial County are exposed to. The investigators will ask the participants to wear a special belt under their clothes during work to measure heat. The investigators will also put two small temperature monitors in the participant's home for a day. The investigators will collect a urine sample to check hydration, and also measure the participants height, weight, blood pressure, and some blood markers for diseases using a simple finger-prick test. To measure chemicals, the investigators will give the participants a wristband to wear for a week and hang another in the participants home. The investigators will also collect dust from each participant's home with a vacuum. Then, the investigators will analyze everything at San Diego State University. After collecting samples, a trained community health worker will ask the participants a few questions about their work, lifestyle, health symptoms, and any hazards they face. The investigators will meet the participants twice at their homes to distribute the tools which will later be collected. Once the tools are collected, the investigators will have the chance to follow up with the participants if they have any questions. 2. Provide help to lower heat and chemical exposure with the help of community health workers. 3. Measure heat and chemicals again using the same methods to see if the project made a difference. 4. Talk to participants about what they liked and how the investigators can make future projects better.

COMPLETED
Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air
Description

We hypothesize that continuous positive pressure applied to the airway will decrease the ability of the nose to warm and humidify inspired air compared to zero or negative pressure. We will use continuous positive airway pressure (CPAP), a device commonly used to treat patients with sleep apnea, to vary the pressure in the airway and determine if increased pressure decreases the ability to warm and humidify inspired air. If our hypothesis is correct, it may explain the reason why CPAP is poorly tolerated in patients with sleep apnea; i.e., less ability to warm and humidify air leading to more nasal mucosal irritation.

Conditions