Anhui Medical University
Hefei, Anhui, 230032, China
Location status: Recruiting
NCT Number: NCT07501923
Assess the acute effects of high-temperature exposure (including both daytime and nighttime conditions) on multiple physiological and psychological indicators, including cardiovascular, respiratory, neuropsychiatric, and metabolic functions, along with their potential mechanisms.
Interested in participating?
Request Info18 year–30 year
All sexes
Interventional
Not applicable
Hefei, Anhui, 230032, China
Location status: Recruiting
This study will be conducted in Hefei, China, as a randomized controlled crossover human exposure trial involving approximately 50 healthy young adults. The primary objective is to systematically evaluate the acute effects of heat exposure-during both daytime and nighttime-on multiple physiological and psychological domains, including cardiovascular, respiratory, neurocognitive, and metabolic functions, and to explore the underlying biological mechanisms.
A randomized crossover design will be employed, comprising three exposure phases: nighttime heat exposure, daytime heat exposure, and combined day-night heat exposure. Each participant will undergo repeated exposures under different temperature conditions, with a washout period of at least three days between sessions to minimize carryover effects.
During the nighttime exposure phase, participants will be randomly assigned to one of two sequences. Group A will first be exposed to a nighttime heat condition at 30°C from 23:00 to 07:00 (8 hours, covering habitual sleep time), followed by exposure to a thermoneutral condition at 26°C after the washout period. Group B will follow the reverse sequence.
In the daytime exposure phase, participants will again be randomized in a crossover manner. Group A will first undergo exposure to a daytime heat condition at 32°C from 09:00 to 17:00 (8 hours, approximating a typical working day), followed by exposure to a 26°C thermoneutral condition after washout. Group B will receive the reverse sequence.
In the combined day-night exposure phase, a continuous heat exposure scenario will be simulated. Group A will first be exposed to both daytime heat (32°C, 09:00-17:00) and nighttime heat (30°C, 23:00-07:00), followed by a thermoneutral condition (26°C throughout the day and night) after washout. Group B will undergo the reverse order.
Throughout each exposure session, participants will remain in a resting state to minimize the confounding effects of physical activity. Health assessments will be conducted before exposure (within 1 hour prior), during exposure, and after exposure (within 2 hours post-exposure). These assessments will include, but are not limited to, ambulatory electrocardiogram (Holter) monitoring, blood pressure measurements, spirometry, cognitive function tests, psychological questionnaires, and collection of biological samples such as blood and urine. This comprehensive evaluation will enable characterization of the acute physiological responses to heat exposure and provide insights into potential mechanistic pathways.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daytime Exposure Phase:
The exposure group will be exposed to high temperature (32#) in a chamber for about 8 hours, resting during the whole periods
Nighttime Exposure Phase:
The exposure group will be exposed to high temperature (30#) in a chamber for about 8 hours, resting during the whole periods
Day-Night Combined Exposure Phase:
The exposure group will be exposed continuously to high temperatures during the day and night
Daytime Exposure Phase:
The control group will be exposed to neutraltemperature (26#) in a chamber for about 8 hours, resting during the whole periods
Nighttime Exposure Phase:
The control group will be exposed to neutral temperature (26#) in a chamber for about 8 hours, resting during the whole periods
Day-Night Combined Exposure Phase:
The control group will be exposed continuously to neutraltemperatures during the day and night
Time frame: Volunteers will be asked to wear smart band for 24 hours from 6:00 A.M. at the day of intervention to 6:00 A.M. at the next day.
Smart Band will be conducted during each exposure session. Time-domain and frequency-domain HRV indices (e.g., SDNN, RMSSD, LF, HF) will be derived to assess autonomic nervous system regulation.
Time frame: Blood pressure will be examined before exposure and immediately (within 10 mins) after the exposure session
Blood pressure will be measured using an automated sphygmomanometer under standardized resting conditions. Both systolic and diastolic values will be recorded.
Time frame: Lung function will be examined before exposure and half an hour after the exposure session
Pulmonary function will be assessed using spirometry according to standardized protocols. FEV1 will be recorded as a measure of airway function.
Time frame: Lung function will be examined before exposure and half an hour after the exposure session
Forced vital capacity will be measured via spirometry to evaluate lung volume and ventilatory function.
Time frame: Blood will be collected 1 hour before and after the exposure session
Venous blood samples will be collected and serum IL-6 concentrations will be quantified using enzyme-linked immunosorbent assay (ELISA) to assess systemic inflammatory response.
Time frame: Blood will be collected 1 hour before and after the exposure session
Serum CRP levels will be measured using high-sensitivity assays as a marker of systemic inflammation.
Time frame: Blood will be collected 1 hour before and after the exposure session
Plasma or urinary F2-isoprostanes will be quantified using validated assays as a stable biomarker of lipid peroxidation and oxidative stress.
Time frame: Blood will be collected 1 hour before and after the exposure session
Serum SOD activity will be measured to evaluate antioxidant defense capacity.
Time frame: Blood will be collected 1 hour before and after the exposure session
Serum creatinine will be measured using standard biochemical methods to assess renal function.
Time frame: Urine will be collected 1 hour before and after the exposure session
Urinary NGAL levels will be quantified using ELISA as an early biomarker of acute kidney injury.
Time frame: Scale assessments will be conducted within one hour before and after exposure.
Psychological status will be assessed using the validated POMS questionnaire to evaluate mood disturbances.
Time frame: Volunteers will be asked to wear smart band for 24 hours from 6:00 A.M. at the day of intervention to 6:00 A.M. at the next day.
Heart rate will be continuously recorded during exposure using wearable devices.
Time frame: Lung function will be examined before exposure and half an hour after the exposure session
PEF will be measured using a portable peak flow meter to assess expiratory function.
Time frame: Blood will be collected 1 hour before and after the exposure session
Serum TNF-α levels will be measured using ELISA.
Time frame: Blood will be collected 1 hour before and after the exposure session
Serum MCP-1 concentrations will be quantified to assess inflammatory activation.
Time frame: Blood will be collected 1 hour before and after the exposure session
Reduced glutathione levels will be measured to assess antioxidant capacity.
Time frame: Blood will be collected 1 hour before and after the exposure session
Blood Urea Nitrogen will be measured using standard biochemical assays.
Time frame: Scale assessments will be conducted within one hour before and after exposure.
Perceived stress will be assessed using the validated Perceived Stress Scale questionnaire.
Contact information is provided by the study sponsor or research team.
Jian Cheng
Other
Randomized Controlled Crossover Trial on the Effects of Daytime, Nighttime, and Combined Heat Exposure on Human Health
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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