NCT06652425

Brief Summary

This is a randomized controlled human exposure crossover study. Investigators aim to assess the acute effects of low temperature exposure on cardiovascular system and the underlying mechanisms.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

October 15, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

October 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2024

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

October 15, 2024

Last Update Submit

February 25, 2025

Conditions

Cardiovascular System

Keywords

Low temperatureRandomized controlled trialCardiovascular system

Outcome Measures

Primary Outcomes (6)

  • Blood Pressure

    The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured.

    Blood pressure will be examined before exposure and immediately after the exposure session

  • SDNN (standard deviation of NN intervals)

    Investigators plan to measure heart rate variability (HRV) parameter SDNN

    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.

  • SDANN (standard deviation of the averages of RR intervals)

    Investigators plan to measure heart rate variability parameter SDANN

    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.

  • rMSSD (root mean square of successive differences)

    Investigators plan to measure heart rate variability (HRV) parameter rMSSD

    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.

  • pNN50 (Percentage of differences between adjacent RR intervals greater than 50 ms)

    Investigators plan to measure heart rate variability (HRV) parameter pNN50

    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.

  • Frequency domain measures: low frequency (LF), high frequency (HF), and LF/HF ratio

    Investigators plan to measure frequency domain parameters of heart rate variability (HRV)

    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.

Secondary Outcomes (2)

  • Changes of scores of symptoms questionnaires

    The questionnaires will be conducted before exposure and immediately after the exposure

  • Changes of skin temperature

    Skin temperature will be examined during the 2-hour exposure session

Other Outcomes (15)

  • Differences in metabolic profiling detected in blood between the two exposures

    1 hour after the exposure session

  • Differences in protein levels detected in blood between the two exposures

    1 hour after the exposure session

  • Differences in RNA expression levels detected in serum transcriptomics between the two exposures

    1 hour after the exposure session

  • +12 more other outcomes

Study Arms (2)

Low temperature (15°C) group

EXPERIMENTAL

Subjects in exposure group will be exposed to low temperature (15°C) for about 2 hours in a chamber.

Other: Low temperature (15°C) group

Moderate temperature (22°C) group

EXPERIMENTAL

Subjects in exposure group will be exposed to moderate temperature (22°C) for about 2 hours in a chamber.

Other: Moderate temperature (22°C) group

Interventions

Low temperature (15°C) groupOTHER

The exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods.

Low temperature (15°C) group
Moderate temperature (22°C) groupOTHER

The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods.

Moderate temperature (22°C) group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Living in Shanghai during the study period;
  • Body mass index \> 18.5 and ≤ 28;
  • Right-handed;
  • Receiving or having received higher education;
  • With the ability to read and understand Chinese smoothly.

You may not qualify if:

  • Smoking and alcohol abuse;
  • Current drug and dietary supplements intake;
  • Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
  • Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
  • Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
  • Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
  • Subjects who have a history of major surgery due to cardiovascular, cerebrovascular, respiratory, or neurological diseases;
  • Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;
  • Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
  • Subjects with color vision disabilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Cold TemperaturePopulation Groups

Intervention Hierarchy (Ancestors)

TemperatureThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public HealthDemographyPopulation Characteristics

Study Officials

  • Haidong Kan, PhD

    Fudan University

    STUDY DIRECTOR

Central Study Contacts

Renjie Chen, PhD

CONTACT

+86-021-54237908chenrenjie@fudan.edu.cn

Haidong Kan, PhD

CONTACT

+86-021-54237908kanh@fudan.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 22, 2024

Study Start

October 16, 2024

Primary Completion

November 16, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)