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El ensayo clínico NCT07501923 para Metabolism Changes, Psychology Functional Behavior, Sistema cardiovascular, Sistema respiratorio está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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The Effects of Daytime, Nighttime, and Combined Heat Exposure on Human Health 35
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07501923 es un estudio intervencionista para Metabolism Changes, Psychology Functional Behavior, Sistema cardiovascular, Sistema respiratorio. Su estado actual es: reclutando. El estudio se inició el 1 de junio de 2025, con el objetivo de reclutar a 35 participantes. Dirigido por Jian Cheng, se espera que finalice el 31 de diciembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 30 de marzo de 2026.
Resumen
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.
Descripción detallada
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 explor...Mostrar más
Título oficial
Randomized Controlled Crossover Trial on the Effects of Daytime, Nighttime, and Combined Heat Exposure on Human Health
Condiciones médicas
Metabolism ChangesPsychology Functional BehaviorSistema cardiovascularSistema respiratorioOtros ID del estudio
- 81250681
Número del NCT
Inicio del estudio (real)
2025-06-01
Última actualización
2026-03-30
Fecha de finalización (estimada)
2026-12-31
Inscripción (prevista)
35
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Diseño cruzado
Enmascaramiento
Simple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
OtrosIntervention / Treatment Daytime or Nighttime High-Temperature Group | Daytime or Nighttime High-Temperature Exposure 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 th...Mostrar más |
OtrosControl Daytime or Nighttime Neutral -Temperature Group | Daytime and nighttime neutral temperature exposure 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 durin...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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. | 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. |
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. | Blood pressure will be examined before exposure and immediately (within 10 mins) after the exposure session |
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. | Lung function will be examined before exposure and half an hour after the exposure session |
Forced Vital Capacity | Forced vital capacity will be measured via spirometry to evaluate lung volume and ventilatory function. | Lung function will be examined before exposure and half an hour after the exposure session |
Interleukin-6 | 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. | Blood will be collected 1 hour before and after the exposure session |
C-reactive Protein | Serum CRP levels will be measured using high-sensitivity assays as a marker of systemic inflammation. | Blood will be collected 1 hour before and after the exposure session |
F2-Isoprostanes | Plasma or urinary F2-isoprostanes will be quantified using validated assays as a stable biomarker of lipid peroxidation and oxidative stress. | Blood will be collected 1 hour before and after the exposure session |
Superoxide Dismutase | Serum SOD activity will be measured to evaluate antioxidant defense capacity. | Blood will be collected 1 hour before and after the exposure session |
Serum Creatinine | Serum creatinine will be measured using standard biochemical methods to assess renal function. | Blood will be collected 1 hour before and after the exposure session |
Urinary Neutrophil Gelatinase-Associated Lipocalin | Urinary NGAL levels will be quantified using ELISA as an early biomarker of acute kidney injury. | Urine will be collected 1 hour before and after the exposure session |
Profile of Mood States | Psychological status will be assessed using the validated POMS questionnaire to evaluate mood disturbances. | Scale assessments will be conducted within one hour before and after exposure. |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Heart Rate | Heart rate will be continuously recorded during exposure using wearable devices. | 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. |
Peak Expiratory Flow | PEF will be measured using a portable peak flow meter to assess expiratory function. | Lung function will be examined before exposure and half an hour after the exposure session |
Tumor Necrosis Factor-alpha | Serum TNF-α levels will be measured using ELISA. | Blood will be collected 1 hour before and after the exposure session |
Monocyte Chemoattractant Protein-1 | Serum MCP-1 concentrations will be quantified to assess inflammatory activation. | Blood will be collected 1 hour before and after the exposure session |
Glutathione | Reduced glutathione levels will be measured to assess antioxidant capacity. | Blood will be collected 1 hour before and after the exposure session |
Blood Urea Nitrogen | Blood Urea Nitrogen will be measured using standard biochemical assays. | Blood will be collected 1 hour before and after the exposure session |
Perceived Stress Scale | Perceived stress will be assessed using the validated Perceived Stress Scale questionnaire. | Scale assessments will be conducted within one hour before and after exposure. |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- 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.
- 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.
Jian ChengParte responsable del estudio
Jian Cheng, Investigador-patrocinador, Professor, Anhui Medical University
Contactos centrales del estudio
Contacto: Jian Jian Cheng, +86 183 5603 7837, [email protected]
1 Centros del estudio en 1 países
Anhui
Anhui Medical University, Hefei, Anhui, 230032, China
Jian Jian Cheng, Contacto, +86 183 5603 7837, [email protected]
Reclutando