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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06385782
Other study ID # 20dz1207200
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date September 1, 2023

Study information

Verified date April 2024
Source Shanghai 10th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date September 1, 2023
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Antarctic environment
. 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.

Locations

Country Name City State
China Shanghai Tenth People's Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ya-Wei Xu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in HRV 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
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