Heart Rate VariabilityNCT06385782
Exploring HRV in Antarctic Overwintering Members of Asia
An observational study of Heart Rate Variability, run by Ya-Wei Xu at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability
- What is being tested?
- Antarctic environment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Team members are volunteers selected through interviews, followed by detailed medical and psychological examinations, and are made up of scientific and logistical staff.
Who cannot join
- People with physical or mental illness
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200079
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Rate Variability
- Being tested
- Antarctic environment
- Keywords
- Heart Rate Variability (HRV); Antarctic Regions; Overwintering; Physical harm; Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antarctic environmentOther
. 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.
| Study group | Role | What they receive |
|---|---|---|
| outdoor groups | Outdoor work time is more than 2 hours Receives: Other: Antarctic environment | |
| indoor groups | Outdoor work time is less than 2 hours Receives: Other: Antarctic environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in HRV
Before and after the expedition to Antarctica, we conducted comparative analyses of HRV data.
Measured: members in Antarctica at Zhongshan Station in the 38th CSEA from December 2021 to April 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Mar 2021
- Primary completion1 Apr 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ya-Wei Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385782
- Sponsor's protocol ID
- 20dz1207200
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduce of Heart Rate Variability of Asian Antarctic Overwintering Members and the Impact Factors--A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06385782
- Acronym / sponsor ID
- 20dz1207200
- Conditions
- Heart Rate Variability
- Keywords
- Heart Rate Variability (HRV); Antarctic Regions; Overwintering; Physical harm; Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ya-Wei XuUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| outdoor groups | – | Other: Antarctic environmentOutdoor work time is more than 2 hours |
| indoor groups | – | Other: Antarctic environmentOutdoor work time is less than 2 hours |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Team members are volunteers selected through interviews, followed by detailed medical and psychological examinations, and are made up of scientific and logistical staff.
Key exclusion criteria (1 listed)
- People with physical or mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | indoor groups, outdoor groups |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Heart Rate Variability
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Recruiting
The Effect of Water Temperature on Heart Rate Variability and Cognition
Mental Acuity
Active, not recruiting
Effects of Individualized Preferred and Higher Treadmill Walking Speeds Followed by Cognitive Training on Heart Rate Variability, Gait Performance, and Motor-Cognitive Function in Older Adults With Type 2 Diabetes: A Randomized Controlled Trial With 4-Week Retention Follow-up
Diabetes Mellitus, Type 2
Not yet recruiting
Music Listening for Chronic Pain in Adults With Early-Stage Dementia
Chronic Pain, Alzheimer Disease
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Variability, run by Ya-Wei Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in HRV (time frame: members in Antarctica at Zhongshan Station in the 38th CSEA from December 2021 to April 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.