The Effects of Daytime, Nighttime, and Combined Heat Exposure on Human Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorJian Cheng
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-30;
In good health, with no history of cardiovascular disease, respiratory disease, diabetes, endocrine disorders, neurological or psychiatric conditions;
No smoking or alcohol addiction, no history of substance abuse;
No prior history of particular sensitivity to high-temperature environments.
Disqualifiers
Individuals who have experienced fever, colds, infectious diseases, or significant physical trauma within two weeks prior to the high-temperature test;
Individuals currently using medications that may affect psychological, cognitive, cardiovascular, or respiratory functions;
Pregnant women and lactating females;
Participants shall not be scheduled to participate during menstruation;
Trial design
Design model
Crossover
Treatments tested in this trial
Daytime or Nighttime High-Temperature Exposure
Other interventionDaytime 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 and nighttime neutral temperature exposure
Other interventionDaytime 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
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Intervention / TreatmentOther 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Heart Rate Variability
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
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.2
Systolic and Diastolic Blood Pressure
Blood pressure will be measured using an automated sphygmomanometer under standardized resting conditions. Both systolic and diastolic values will be recorded.
Time frame
Blood pressure will be examined before exposure and immediately (within 10 mins) after the exposure session3
Forced Expiratory Volume in 1 Second
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 session4
Forced Vital Capacity
Forced vital capacity will be measured via spirometry to evaluate lung volume and ventilatory function.
Time frame
Lung function will be examined before exposure and half an hour after the exposure sessionSecondary outcomes
1
Heart Rate
Heart rate will be continuously recorded during exposure using wearable devices.
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.2
Peak Expiratory Flow
PEF will be measured using a portable peak flow meter to assess expiratory function.
Time frame
Lung function will be examined before exposure and half an hour after the exposure session3
Tumor Necrosis Factor-alpha
Serum TNF-α levels will be measured using ELISA.
Time frame
Blood will be collected 1 hour before and after the exposure session4
Monocyte Chemoattractant Protein-1
Serum MCP-1 concentrations will be quantified to assess inflammatory activation.
Time frame
Blood will be collected 1 hour before and after the exposure sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jian Cheng
Lead sponsor
Anhui Medical University
Sponsor institution
Source ClinicalTrials.gov