Sex DifferencesNCT04608435
Sex Differences in Postoperative Sleep Quality and Inflammation
An observational study of Sex Differences and Postoperative Sleep Quality, run by Shengjing Hospital at 1 site in China.
Trial summary
Video-Assisted Thoracoscopic Surgery(VATS) is among the most common and disabling persistent pain and inflammation conditions, with increasing prevalence in the developed world, and affects women to a greater degree than men. And sleep disruption also remains a challenging problem in surgical settings. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sex Differences, Postoperative Sleep Quality, Postoperative Pain
- What is being tested?
- Video-Assisted Thoracoscopic Surgery
- How many people
- 213 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2020to 27 Feb 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing video-assisted thoracoscopic surgery under general anesthesia
Who may be able to join
- 18-80 years old
- ASA I-III
- under general anesthesia
Who cannot join
- patients with central nervous system and mental diseases;
- patients with preoperative sleep disturbances;
- patients with a history of sedative, analgesic, or antidepression drug use;
- patients with sleep apnea or moderate and severe obstructive sleep apnea-hypopnea syndrome;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sex Differences in Postoperative Sleep Quality and Inflammation in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Video-Assisted Thoracoscopic Surgery(VATS) is among the most common and disabling persistent pain and inflammation conditions, with increasing prevalence in the developed world, and affects women to a greater degree than men. And sleep disruption also remains a challenging problem in surgical settings. Postoperative sleep disturbances (POSD) are defined as changes in the sleep structure and quality of patients during the early stages after surgery, which are manifested as significantly shortened rapid eye movement (REM) sleep, prolonged awake time, and sleep fragmentation. Long-term POSD may increase the risk of postoperative delirium or cognitive dysfunction and delay recovery, thereby worsening the patient's physical condition. The aim of the study was to investigate the effect of sex differences on postoperative pain, inflammation and sleep quality among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.
- Being tested
- Video-Assisted Thoracoscopic Surgery
- Keywords
- sex differences, postoperative sleep quality, postoperative pain, inflammation function
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Assisted Thoracoscopic SurgeryOther
patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Male Group | Not described Receives: Other: Video-Assisted Thoracoscopic Surgery | |
| Female Group | Not described Receives: Other: Video-Assisted Thoracoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality of one night before surgery
Use Athens insomnia scale to test the sleep quality the first night before surgery
Measured: first night before surgery
sleep quality of first night after surgery
Use Athens insomnia scale to test the sleep quality the first night after surgery
Measured: first night after surgery
sleep quality of third night after surgery
Use Athens insomnia scale to test the sleep quality the third night after surgery
Measured: third night after surgery
Secondary outcomes (14)
visual analog scale(VAS) score after surgery
evaluate VAS score after surgery
Measured: one day before surgery
visual analog scale(VAS) score after surgery
evaluate VAS score after surgery
Measured: 3 hours after surgery
visual analog scale(VAS) score after surgery
evaluate VAS score after surgery
Measured: 8 pm the first day after surgery
postoperative adverse effect
evaluate postoperative adverse effect 24 hours after surgery
Measured: 24 hours after surgery
perioperative inflammation function
evaluate neutrophils
Measured: two days before surgery
perioperative inflammation function
evaluate platelet
Measured: two days before surgery
perioperative inflammation function
evaluate lymphocyte
Measured: two days before surgery
perioperative inflammation function
evaluate neutrophils,platelet,lymphocyte
Measured: first days after surgery
perioperative inflammation function
evaluate neutrophils
Measured: first days after surgery
perioperative inflammation function
evaluate platelet
Measured: first days after surgery
perioperative inflammation function
evaluate lymphocyte
Measured: first days after surgery
Postoperative cognition evaluation
Use MMSE Mini-Mental State Examination (MMSE) was also evaluated at Sleep preop 1, Sleep POD 1 and Sleep POD 3.18 Each correct answer is 1 point, and error or unknown is 0 point. The unsuitable one is 9 points, and refusing to answer or incomprehension is 8 points. In the total score, 8 points and 9 points are calculated by 0 points. The highest score is 30 points. The division of dementia or not is related to the degree of education. The dementia is affirmed by the patient who is illiterate and less than 17 points, the primary school is less than 20 points, and more than middle school is less than 24 points. The scores which from 27 to 30 is normal, 21 to 26 of mild, 10 to 20 of moderate, and from 0 to 9 is severe.
Measured: one day before surgery
Postoperative cognition evaluation
Use MMSE Mini-Mental State Examination (MMSE) was also evaluated at Sleep preop 1, Sleep POD 1 and Sleep POD 3.18 Each correct answer is 1 point, and error or unknown is 0 point. The unsuitable one is 9 points, and refusing to answer or incomprehension is 8 points. In the total score, 8 points and 9 points are calculated by 0 points. The highest score is 30 points. The division of dementia or not is related to the degree of education. The dementia is affirmed by the patient who is illiterate and less than 17 points, the primary school is less than 20 points, and more than middle school is less than 24 points. The scores which from 27 to 30 is normal, 21 to 26 of mild, 10 to 20 of moderate, and from 0 to 9 is severe.
Measured: first day after surgery
Postoperative cognition evaluation
Use MMSE Mini-Mental State Examination (MMSE) was also evaluated at Sleep preop 1, Sleep POD 1 and Sleep POD 3.18 Each correct answer is 1 point, and error or unknown is 0 point. The unsuitable one is 9 points, and refusing to answer or incomprehension is 8 points. In the total score, 8 points and 9 points are calculated by 0 points. The highest score is 30 points. The division of dementia or not is related to the degree of education. The dementia is affirmed by the patient who is illiterate and less than 17 points, the primary school is less than 20 points, and more than middle school is less than 24 points. The scores which from 27 to 30 is normal, 21 to 26 of mild, 10 to 20 of moderate, and from 0 to 9 is severe.
Measured: third day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start31 Oct 2020
- Primary completion20 Feb 2022
- Study completion27 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sex DifferencesStudies 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
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608435
- Sponsor's protocol ID
- Sex, sleep and inflammation
- Status last verified
- Apr 2022
- First submitted
- 23 Oct 2020
- Last updated
- 4 May 2022
- 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 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Postoperative Sleep Quality and Inflammation in Patients Undergoing Video-Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT04608435
- Acronym / sponsor ID
- Sex, sleep and inflammation
- Keywords
- sex differences, postoperative sleep quality, postoperative pain, inflammation function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 31 Oct 2020 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 29 Oct 2020 (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.
Video-Assisted Thoracoscopic Surgery(VATS) is among the most common and disabling persistent pain and inflammation conditions, with increasing prevalence in the developed world, and affects women to a greater degree than men. And sleep disruption also remains a challenging problem in surgical settings. Postoperative sleep disturbances (POSD) are defined as changes in the sleep structure and quality of patients during the early stages after surgery, which are manifested as significantly shortened rapid eye movement (REM) sleep, prolonged awake time, and sleep fragmentation. Long-term POSD may increase the risk of postoperative delirium or cognitive dysfunction and delay recovery, thereby worsening the patient's physical condition. The aim of the study was to investigate the effect of sex differences on postoperative pain, inflammation and sleep quality among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male Group | – | Other: Video-Assisted Thoracoscopic Surgery |
| Female Group | – | Other: Video-Assisted Thoracoscopic Surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing video-assisted thoracoscopic surgery under general anesthesia
Key inclusion criteria (3 listed)
- 18-80 years old
- ASA I-III
- under general anesthesia
Key exclusion criteria (4 listed)
- patients with central nervous system and mental diseases;
- patients with preoperative sleep disturbances;
- patients with a history of sedative, analgesic, or antidepression drug use;
- patients with sleep apnea or moderate and severe obstructive sleep apnea-hypopnea syndrome;
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 |
|---|---|---|
| Video-Assisted Thoracoscopic Surgerypatients receive Video-Assisted Thoracoscopic Surgery under general anesthesia | Other | Female Group, Male Group |
Primary outcome
sleep quality of one night before surgery
Time frame: first night before surgery
Use Athens insomnia scale to test the sleep quality the first night before surgery
sleep quality of first night after surgery
Time frame: first night after surgery
Use Athens insomnia scale to test the sleep quality the first night after surgery
sleep quality of third night after surgery
Time frame: third night after surgery
Use Athens insomnia scale to test the sleep quality the third night after surgery
14 secondary outcomes
visual analog scale(VAS) score after surgery
Time frame: one day before surgery
visual analog scale(VAS) score after surgery
Time frame: 3 hours after surgery
visual analog scale(VAS) score after surgery
Time frame: 8 pm the first day after surgery
postoperative adverse effect
Time frame: 24 hours after surgery
perioperative inflammation function
Time frame: two days before surgery
perioperative inflammation function
Time frame: two days before surgery
perioperative inflammation function
Time frame: two days before surgery
perioperative inflammation function
Time frame: first days after surgery
perioperative inflammation function
Time frame: first days after surgery
perioperative inflammation function
Time frame: first days after surgery
perioperative inflammation function
Time frame: first days after surgery
Postoperative cognition evaluation
Time frame: one day before surgery
Postoperative cognition evaluation
Time frame: first day after surgery
Postoperative cognition evaluation
Time frame: third day after surgery
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 4 May 2022.
- Individual participant dataSharing planned: No
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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 Sex Differences and Postoperative Sleep Quality, run by Shengjing Hospital 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 3 inclusion and 4 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 4 May 2022. 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?
sleep quality of one night before surgery (time frame: first night before surgery). The study lists 3 primary outcomes in all. 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 4 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.