Autonomic Nervous System ImbalanceNCT06542510
The Impact of Working Night Shifts on Cardiac Autonomic Nervous Regulation During the Six-minute Walk Test in Nurses
An observational study of Autonomic Nervous System Imbalance, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
To evaluate changes in heart rate variability (HRV) after the six-minute walk test (6MWT) in nurses following a night shift and explore the impact of night shift work on the regulation of the autonomic nervous system in the heart. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Imbalance
- What is being tested?
- working night shift
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2024to 30 Apr 2024
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The participants were nurses from Nanfang Hospital of Southern Medical University who worked ward shifts. The nurses in this study had one night shift every 5-10 days, from 00:00 a.m. to 8:00 a.m., followed by 2-3 days off.
Who may be able to join
- Female nurses aged ≥ 18 years who had undergone annual physical examinations, did not have serious cardiopulmonary diseases, and were able to walk normally were considered for inclusion in the study.
Who cannot join
- (ⅰ) having children at home who require night care; (ⅱ) current pregnancy; (ⅲ) engaging in activities that significantly impact heart rate, such as sexual activity, 24 hours before and 24 hours after working night shifts; (ⅳ) history of thyroid dysfunction, hypertension, diabetes, coronary heart disease, etc.; (ⅴ) experiencing upper respiratory tract infection, fever, cough, diarrhea, or other illnesses within 1 week before the planned enrollment; (ⅵ) consuming coffee or strong tea, smoking, drinking alcohol, or using other substances that affect heart rate 3 days before the planned enrollment; (ⅶ) taking β-receptor blockers, sleeping pills, psychotropic drugs, or other medications that affect heart rate; and (ⅷ) judged by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
To evaluate changes in heart rate variability (HRV) after the six-minute walk test (6MWT) in nurses following a night shift and explore the impact of night shift work on the regulation of the autonomic nervous system in the heart.
Thirty-five female nurses, with a mean age of 28.7 years (range 21.0-37.0 years), participated in this study. On the first and second mornings after a night shift, the nurses performed the 6MWT. During the test, electrocardiogram (ECG) signals, blood pressure, and walking distance were recorded simultaneously.
- Conditions
- Autonomic Nervous System Imbalance
- Being tested
- working night shift
- Keywords
- heart rate variability; night shift; autonomic nervous system; six-minute walk test; nurses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
working night shiftBehavioural
Also called night shift
working night shift
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta HRV during the 6MWT
On the first and second mornings after a night shift, the nurses performed the 6MWT.During the test, electrocardiogram (ECG) signals was recorded simultaneously.
Measured: 18 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start30 Jan 2024
- Primary completion15 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autonomic Nervous System ImbalanceStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542510
- Sponsor's protocol ID
- NFEC-2024-064
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of the study are available from the corresponding author upon reasonable request.
Publications
Zhan T, Zhang Z, Shi Z, Xie H, Zha D, Wei X. Factors influencing heart rate variability in nurses following night shifts: a prospective observational clinical study. BMC Nurs. 2025 Oct 22;24(1):1318. doi: 10.1186/s12912-025-03975-0.
PubMed 41126139Zhan T, Wei X, Zhang Z, Shi Z, Xie H, Ma X, Pan S, Zha D. The impact of working night shifts on cardiac autonomic nervous regulation during the six-minute walk test in nurses. BMC Nurs. 2024 Dec 18;23(1):907. doi: 10.1186/s12912-024-02563-y.
PubMed 39696211
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Working Night Shifts on Cardiac Autonomic Nervous Regulation During the Six-minute Walk Test in Nurses
- ClinicalTrials.gov ID
- NCT06542510
- Acronym / sponsor ID
- NFEC-2024-064
- Conditions
- Autonomic Nervous System Imbalance
- Keywords
- heart rate variability; night shift; autonomic nervous system; six-minute walk test; nurses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 Aug 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.
To evaluate changes in heart rate variability (HRV) after the six-minute walk test (6MWT) in nurses following a night shift and explore the impact of night shift work on the regulation of the autonomic nervous system in the heart.
Thirty-five female nurses, with a mean age of 28.7 years (range 21.0-37.0 years), participated in this study. On the first and second mornings after a night shift, the nurses performed the 6MWT. During the test, electrocardiogram (ECG) signals, blood pressure, and walking distance were recorded simultaneously.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants were nurses from Nanfang Hospital of Southern Medical University who worked ward shifts. The nurses in this study had one night shift every 5-10 days, from 00:00 a.m. to 8:00 a.m., followed by 2-3 days off.
Key inclusion criteria (1 listed)
- Female nurses aged ≥ 18 years who had undergone annual physical examinations, did not have serious cardiopulmonary diseases, and were able to walk normally were considered for inclusion in the study.
Key exclusion criteria (1 listed)
- (ⅰ) having children at home who require night care; (ⅱ) current pregnancy; (ⅲ) engaging in activities that significantly impact heart rate, such as sexual activity, 24 hours before and 24 hours after working night shifts; (ⅳ) history of thyroid dysfunction, hypertension, diabetes, coronary heart disease, etc.; (ⅴ) experiencing upper respiratory tract infection, fever, cough, diarrhea, or other illnesses within 1 week before the planned enrollment; (ⅵ) consuming coffee or strong tea, smoking, drinking alcohol, or using other substances that affect heart rate 3 days before the planned enrollment; (ⅶ) taking β-receptor blockers, sleeping pills, psychotropic drugs, or other medications that affect heart rate; and (ⅷ) judged by the investigator to be unsuitable for participation in this study.
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 |
|---|---|---|
| working night shiftAlso: night shiftworking night shift | Behavioural | – |
Primary outcome
Delta HRV during the 6MWT
Time frame: 18 minutes
On the first and second mornings after a night shift, the nurses performed the 6MWT.During the test, electrocardiogram (ECG) signals was recorded simultaneously.
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 7 Aug 2024.
- Derived from this study: PubMed 41126139Zhan T, Zhang Z, Shi Z, Xie H, Zha D, Wei X. Factors influencing heart rate variability in nurses following night shifts: a prospective observational clinical study. BMC Nurs. 2025 Oct 22;24(1):1318. doi: 10.1186/s12912-025-03975-0.
- Derived from this study: PubMed 39696211Zhan T, Wei X, Zhang Z, Shi Z, Xie H, Ma X, Pan S, Zha D. The impact of working night shifts on cardiac autonomic nervous regulation during the six-minute walk test in nurses. BMC Nurs. 2024 Dec 18;23(1):907. doi: 10.1186/s12912-024-02563-y.
- Individual participant dataSharing planned: Yes. The data of the study are available from the corresponding author upon reasonable request.
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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 Autonomic Nervous System Imbalance, run by Nanfang Hospital, Southern Medical University 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 7 Aug 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?
Delta HRV during the 6MWT (time frame: 18 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06542510, which also lists 2 linked publications.
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 7 Aug 2024.