Acute Health Effects of High Temperature Exposure
NCT05575752, Not applicable, Active not recruiting, Fudan University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Acute Health Effects of High Temperature Exposure | ClinicalTrials.gov |
| NCT number | NCT05575752 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 30 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Fudan University | ClinicalTrials.gov |
| Conditions | Cardiovascular System, Respiratory System, Cognitive Function | ClinicalTrials.gov |
| Interventions | high temperature (32℃) group, moderate temperature (22℃) group | ClinicalTrials.gov |
| First posted | 2022-10-12 | ClinicalTrials.gov |
| Last updated | 2026-09-02 | ClinicalTrials.gov |
Registered outcomes 60
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes of pulse wave velocity measured by an arteriography device performing oscillometric measurement | Pulse wave velocity will be examined before exposure and immediately after the exposure session | Pulse wave velocity (PWV) is one of the arterial stiffness indicators. The changes of PWV will be measured. | ClinicalTrials.gov |
| Primary | Changes of AIx@75 measured by an arteriography device performing oscillometric measurement | AIx@75 will be examined before exposure and immediately after the exposure session | Augmentation index normalized to 75 bpm heart rate (AIx@75) is one of the arterial stiffness indicators. The changes of AIx@75 will be measured. | ClinicalTrials.gov |
| Primary | Changes of reflection magnitude measured by an arteriography device performing oscillometric measurement | Reflection magnitude will be examined before exposure and immediately after the exposure session | Reflection magnitude is one of the arterial stiffness indicators. The changes of reflection magnitude will be measured. | ClinicalTrials.gov |
| Primary | Results of Stroop Tests | The tests will be conducted before exposure and immediately after the exposure session | Investigators plan to measure the changes of cognitive function using Stroop Test. The time taken to complete the test could reflect cognitive function, and a shorter time means better cognitive function. | ClinicalTrials.gov |
| Primary | Changes of forced expiratory volume in the first second (FEV1) | The tests will be examined before exposure and half an hour after exposure | Investigators plan to measure the changes of the forced expiratory volume in 1 s (FEV1) using a smart spirometer (Model A1, BreathHome, China) supervised by professional medical staff. Before the pulmonary function test, subjects will practice several times by themselves. During the examination, each subject stands and clamps the nose clip, and repeats the test, with the best result as the criterion. FEV1 reflect pulmonary function. | ClinicalTrials.gov |
| Primary | Changes of forced vital capacity (FVC) | FVC will be examined before exposure and half an hour after exposure | Investigators plan to measure the changes of forced vital capacity (FVC) using spirometer (Model A1, BreathHome, China). FVC reflects the expiratory resistance of large airways. | ClinicalTrials.gov |
| Primary | Changes of peak expiratory flow rate (PEF) | FVC will be examined before exposure and half an hour after exposure | Investigators plan to measure the changes of peak expiratory flow (PEF) using smart spirometer (Model A1, BreathHome, China). PEF reflects airway patency and respiratory muscle strength. | ClinicalTrials.gov |
| Primary | Changes of maximum expiratory flow rate at 25% vital capacity (MEF25) | MEF25 will be examined before exposure and half an hour after exposure | Investigators plan to measure the changes of maximum expiratory flow rate at 25% vital capacity. MEF25% reflects the early stage of expiratory flow rate. | ClinicalTrials.gov |
| Primary | Changes of maximum expiratory flow rate at 50% vital capacity (MEF50) | MEF50 will be examined before exposure and half an hour after exposure | Investigators plan to measure the changes of maximum expiratory flow rate at 50% vital capacity using smart spirometer (Model A1, BreathHome, China). MEF50 reflects the interim stage of expiratory flow rate. | ClinicalTrials.gov |
| Primary | Changes of maximum expiratory flow rate at 75% vital capacity (MEF75) | MEF75 will be examined before exposure and half an hour after exposure | Investigators plan to measure the changes of maximum expiratory flow rate at 50% vital capacity (MEF75%) using smart spirometer (Model A1, BreathHome, China). MEF75 reflects the terminal stage of expiratory flow rate. | ClinicalTrials.gov |
| Secondary | Blood Pressure | Blood pressure will be examined before exposure and immediately after the exposure session | The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured. | ClinicalTrials.gov |
| Secondary | Results of Schulte table Tests | The tests will be conducted before exposure and immediately after the exposure session | Investigators plan to measure the changes of cognitive function using Schulte table. The time taken to complete the test and the accuracy could reflect cognitive function. Less time and greater accuracy mean better cognitive function. | ClinicalTrials.gov |
| Secondary | Activated brain regions demonstrating neural activity related to the high temperature exposure | 1 hour after exposure session | Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data. The fractional amplitude of low frequency fluctuation (fALFF) would be extracted to reflect neural activity of brain regions. | ClinicalTrials.gov |
| Secondary | Activated brain regions demonstrating neural connectivity related to the high temperature exposure | 1 hour after exposure session | Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data. The degree of centrality (DC) would be extracted to reflect neural connectivity of brain regions. | ClinicalTrials.gov |
| Secondary | Activated brain regions demonstrating neural synchronization related to the high temperature exposure | 1 hour after exposure session | Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data. The regional homogeneity (ReHo) would be extracted to reflect neural synchronization of brain regions. | ClinicalTrials.gov |
| Secondary | Changes of airway inflammation indicator fractional concentration of carbon monoxide (FeCO) | FeCO will be examined before exposure and half an hour after exposure | Investigators plan to measure the changes of fractional concentration of carbon monoxide. | ClinicalTrials.gov |
| Secondary | Changes of airway inflammation indicator fractional exhaled nitric oxide (FeNO) | FeNO will be examined before exposure and half an hour after exposure | Investigators plan to measure the changes of fractional exhaled nitric oxide. | ClinicalTrials.gov |
| Other | Changes of the scores of thermal sensation questionnaires | before exposure and immediately after the exposure session | Changes of scores of thermal sensation questionnaires which ranged from -5 to 5. Zero score refers to the thermal comfort sensation. Higher scores refer to more uncomfortable sensations of hot. Lower scores refer to more uncomfortable sensations of cold. | ClinicalTrials.gov |
| Other | Differences in RNA expression levels detected in serum transcriptomics between the two exposures | 1 hour after the exposure session | Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome RNA in serum after high temperature exposure | ClinicalTrials.gov |
| Other | Differences in protein levels detected in blood Clara cell protein (CC16) between the two exposures | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session | Investigators plan to measure the changes of Clara cell protein using enzyme linked immunosorbent assay (ELISA). Clara cell protein (CC16) indicate lung epithelial injury. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Ordered Number Search Task | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)