Acute Health Effects of Low Temperature Exposure
NCT06076629, 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 Low Temperature Exposure | ClinicalTrials.gov |
| NCT number | NCT06076629 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Fudan University | ClinicalTrials.gov |
| Conditions | Cardiovascular System, Respiratory System, Cognitive Function | ClinicalTrials.gov |
| Interventions | Low temperature (16#) group, Moderate temperature (22#) group | ClinicalTrials.gov |
| First posted | 2023-10-11 | ClinicalTrials.gov |
| Last updated | 2026-09-02 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Heart Rate Variability Parameters | Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 1:00 P.M. at the day of intervention to 1:00 P.M. at the next day. | Investigators plan to measure heart rate variability (HRV) parameters (e.g., SDNN, PNN50, LF, HF) | ClinicalTrials.gov |
| Primary | 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 |
| Primary | Forced vital capacity | Lung function will be examined before exposure and half an hour after the exposure session | Investigators plan to measure forced vital capacity (FVC) by spirometry | ClinicalTrials.gov |
| Primary | Forced expiratory volume in one second | Lung function will be examined before exposure and half an hour after the exposure session | Investigators plan to measure forced expiratory volume in one second (FEV1) by spirometry. | ClinicalTrials.gov |
| Primary | Maximal mid-expiratory flow | Lung function will be examined before exposure and half an hour after the exposure session | Investigators plan to measure maximal mid-expiratory flow (MMEF) by spirometry. | 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. | ClinicalTrials.gov |
| Secondary | Changes of skin temperature | Skin temperature will be examined from 1:00 P.M. to 4:30 P.M. at the day of intervention | The changes of wrist skin temperature will be measured | ClinicalTrials.gov |
| Secondary | Results of simple reaction time | Simple reaction time will be examined before exposure and immediately after the exposure session | Investigators plan to measure the changes of cognitive function using visual simple reaction time test. | ClinicalTrials.gov |
| Secondary | Results of visual memory | Visual memory will be examined before exposure and immediately after the exposure session | Investigators plan to measure the changes of cognitive function using visual memory test. Every level, a number of tiles will flash white. The participants will be required to memorize them, and pick them again after the tiles are reset. Higher levels refer to better visual memory. | ClinicalTrials.gov |
| Secondary | Activated brain regions demonstrating brain activity related to the low temperature exposure | MRI will be examined 1 hour after the exposure session | Investigators plan to conduct magnetic resonance imaging (MRI) after exposure. The MRI data will be processed through Data Processing and Analysis for Brain Imaging (DPABI) sofrware to obtain brain activity parameters, such as fractional amplitude of low-frequency fluctuation (fALFF). Brain regions that change after exposure between the two groups would be further idenfitied. | ClinicalTrials.gov |
| Secondary | Changes in cerebral hemodynamics demonstrating brain activity related to the low temperature exposure | fNIRS will be examined before exposure and immediately after the exposure session | Investigators plan to conduct functional near-infrared spectroscopy (fNIRS) to measure the changes in oxygenated hemoglobin and deoxygenated hemoglobin after exposure. Matlab would be applied to process data and evaluate the changes in cerebral hemodynamics associated with low temperature exposure | ClinicalTrials.gov |
| Other | Differences in metabolites detected in blood between the two exposures | Blood will be collected 1 hour after the exposure session | The differentially expressed metabolites in blood related to low temperature exposure will be detected by maspectrometry-based non-targeted metabolomics. | ClinicalTrials.gov |
| Other | Differences in protein levels detected in blood between the two exposures | Blood will be collected 1 hour after the exposure session | The differentially expressed proteins in blood related to low temperature exposure will be detected by non-targeted proteomics. | ClinicalTrials.gov |
| Other | Differences in DNA methylation levels detected in whole-blood between the two exposures | Blood will be collected 1 hour after the exposure session | Genome-wide DNA methylation in whole-blood were detected. The study is to identify differential CpG loci after low temperature exposure | ClinicalTrials.gov |
| Other | Changes of the scores of thermal sensation questionnaires | The questionnaires will be conducted 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 | Changes of scores of symptoms questionnaires | The questionnaires will be conducted before exposure and immediately after the exposure session | Changes of scores of respiratory and cardiovascular symptoms questionnaires which ranged from 0 to 5. Zero score refers to no symptoms, and higher scores refer to more severe symptoms. | ClinicalTrials.gov |
| Other | Change in C reactive protein (CRP) concentrations | Blood will be collected 1 hour after the exposure session | Change in the concentrations of C reactive protein in blood. | ClinicalTrials.gov |
| Other | Changes of facial secreted sebum composition | Facial sample will be collected half an hour after the exposure session | Investigators plan to collect facial secreted sebum composition using Sebutape. The differential facial secreted sebum composition between the two groups would be further evaluated. | 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 |
| Simple Reaction Time | 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)