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NCT Number: NCT07501923

The Effects of Daytime, Nighttime, and Combined Heat Exposure on Human Health

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Individuals with a history of fainting or severe discomfort caused by high temperatures.

Treatment and study plan

Daytime or Nighttime High-Temperature Exposure

Other

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 and nighttime neutral temperature exposure

Other

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

Primary outcomes

  1. Heart Rate Variability

    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.

  2. Systolic and Diastolic Blood Pressure

    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.

  3. Forced Expiratory Volume in 1 Second

    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.

  4. Forced Vital Capacity

    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.

  5. Interleukin-6

    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.

  6. C-reactive Protein

    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.

  7. F2-Isoprostanes

    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.

  8. Superoxide Dismutase

    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.

  9. Serum Creatinine

    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.

  10. Urinary Neutrophil Gelatinase-Associated Lipocalin

    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.

  11. Profile of Mood States

    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.

Secondary outcomes

  1. Heart Rate

    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.

  2. Peak Expiratory Flow

    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.

  3. Tumor Necrosis Factor-alpha

    Time frame: Blood will be collected 1 hour before and after the exposure session

    Serum TNF-α levels will be measured using ELISA.

  4. Monocyte Chemoattractant Protein-1

    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.

  5. Glutathione

    Time frame: Blood will be collected 1 hour before and after the exposure session

    Reduced glutathione levels will be measured to assess antioxidant capacity.

  6. Blood Urea Nitrogen

    Time frame: Blood will be collected 1 hour before and after the exposure session

    Blood Urea Nitrogen will be measured using standard biochemical assays.

  7. Perceived Stress Scale

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Jian Cheng

CONTACT

[email protected]

+86 183 5603 7837

Sponsors and collaborators

Lead sponsor

Jian Cheng

Other

Registry information

Official study title

Randomized Controlled Crossover Trial on the Effects of Daytime, Nighttime, and Combined Heat Exposure on Human Health

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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