- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06385782
Exploring HRV in Antarctic Overwintering Members of Asia
April 23, 2024 updated by: Ya-Wei Xu
Reduce of Heart Rate Variability of Asian Antarctic Overwintering Members and the Impact Factors--A Prospective Observational Study
Extreme changes in the Antarctic environment can cause emotional and autonomic dysfunction.
In this study, volunteers from the Antarctica stations in China provided scale scores and heart rate variability (HRV) data, which were used to assess the autonomic nervous system.
Enroll twenty-two members from Zhongshan Station and the Great Wall Station who are overwintering.
Using the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire-9 (PHQ-9) scale, and the SF-36 quality of life scale to evaluate the individual's general physical and mental health.
Analyze HRV and other associated parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was a prospective observational study.
We selected 12 members in Antarctica at the Great Wall Station of the 37th Chinese Antarctic Scientific Expedition (CSEA) from March 2021 to April 2022.
And 10 members in Antarctica at Zhongshan Station in the 38th CSEA from December 2021 to April 2023.
There were 22 members in total.
Team members are volunteers selected through interviews, followed by detailed medical and psychological examinations, and are made up of scientific and logistical staff.
According to the different work content of the scientific expedition team members, and taking the average outdoor working time of 2 hours/day as the node, the scientific expedition team members are divided into outdoor groups (n=12) and indoor groups (n=10).
Participants will be assessed on the day they enter the Antarctic station and leave.
Assessments include HRV, SF-36 quality of life questionnaire, Patient Health Questionnaire-9 (PHQ-9) scale and Generalized Anxiety Disorder (GAD-7) scale.
This study approved by the local ethics committee of Shanghai Tenth People's Hospital, and conformed to the Declaration of Helsinki and its later amendments.
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200079
- Shanghai Tenth People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
This study was a prospective observational study.
We selected 12 members in Antarctica at the Great Wall Station of the 37th Chinese Antarctic Scientific Expedition (CSEA) from March 2021 to April 2022.
And 10 members in Antarctica at Zhongshan Station in the 38th CSEA from December 2021 to April 2023.
There were 22 members in total.
Team members are volunteers selected through interviews, followed by detailed medical and psychological examinations, and are made up of scientific and logistical staff.
Description
Inclusion Criteria:
- Team members are volunteers selected through interviews, followed by detailed medical and psychological examinations, and are made up of scientific and logistical staff.
Exclusion Criteria:
- People with physical or mental illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
outdoor groups
Outdoor work time is more than 2 hours
|
. According to the different work content of the scientific expedition team members, and taking the average outdoor working time of 2 hours/day as the node, the scientific expedition team members are divided into outdoor groups (n=12) and indoor groups (n=10).
Participants will be assessed on the day they enter the Antarctic station and leave.
|
|
indoor groups
Outdoor work time is less than 2 hours
|
. According to the different work content of the scientific expedition team members, and taking the average outdoor working time of 2 hours/day as the node, the scientific expedition team members are divided into outdoor groups (n=12) and indoor groups (n=10).
Participants will be assessed on the day they enter the Antarctic station and leave.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in HRV
Time Frame: members in Antarctica at Zhongshan Station in the 38th CSEA from December 2021 to April 2023
|
Before and after the expedition to Antarctica, we conducted comparative analyses of HRV data.
|
members in Antarctica at Zhongshan Station in the 38th CSEA from December 2021 to April 2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
April 1, 2022
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
April 23, 2024
First Submitted That Met QC Criteria
April 23, 2024
First Posted (Actual)
April 26, 2024
Study Record Updates
Last Update Posted (Actual)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 20dz1207200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Rate Variability
-
University of Southern CaliforniaTerminated
-
National Taiwan University HospitalUnknownHeart Rate VariabilityTaiwan
-
University of California, IrvineNational Institute on Minority Health and Health Disparities (NIMHD); Emory...Completed
-
Université du Québec a MontréalCollège d'Études Ostéopathiques de MontrealCompletedHeart Rate VariabilityCanada
-
Imam Abdulrahman Bin Faisal UniversityCompletedHeart Rate VariabilitySaudi Arabia
-
Florida State UniversityCompletedHeart Rate Variability | Appetite | Resting Metabolic RateUnited States
-
Inonu UniversityCompletedHeart Rate Variability | SportTurkey
-
Sinop UniversityNot yet recruitingHeart Rate VariabilityTurkey (Türkiye)
-
PepsiCo Global R&DRecruitingHeart Rate VariabilityUnited States
-
University of Sao PauloUnknownHeart Rate VariabilityBrazil
Clinical Trials on Antarctic environment
-
University of Alabama at BirminghamNational Cancer Institute (NCI); National Institutes of Health (NIH)Active, not recruiting
-
University of MinnesotaNorthwestern UniversityRecruitingPreDiabetes | Stress and Anxiety | Heart Rate Variability (HRV) | Stress BiomarkersUnited States
-
University of ConnecticutBHSAI; Harvard-NIOSH Education and Research Center (ERC)CompletedHyperthermia | HypothermiaUnited States
-
Petros DinasCompleted
-
Indiana UniversityUnited States Department of DefenseNot yet recruiting
-
Cornell UniversityCompleted
-
University of South FloridaEnrolling by invitation
-
Gérond'ifRecruitingAutonomous Subjects, Aged 65 and Afraid of FallingFrance
-
University of RochesterNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Medical University of ViennaCompletedMultitasking BehaviorAustria