Postoperative Sleep DisturbanceNCT07716085
Dynamic Prediction of Sleep Protection Demand on the First Postoperative Night and Its Influence on Ward Process After Thoracoscopic Lobectomy or Segmentectomy
An observational study of Postoperative Sleep Disturbance, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
This study combines retrospective data analysis with a single-center prospective non-interventional cohort study to understand postoperative sleep disturbance on the first night after video-assisted thoracoscopic (VATS) lobectomy or segmentectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Sleep Disturbance
- What is being tested?
- Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 23 Jul 2026to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years and older undergoing elective video-assisted thoracoscopic (VATS) lobectomy or segmentectomy within a single-center thoracic surgery perioperative care pathway. Participants are drawn from the routine inpatient population managed under standard enhanced recovery after surgery (ERAS) protocols, with planned postoperative admission to a general thoracic ward, ASA physical status I-III, capacity to understand and complete study questionnaires, and willingness to provide informed consent. The population encompasses the perioperative window from preoperative assessment through PACU recovery to the first postoperative night.
Who may be able to join
- Aged 18 years or older; Scheduled for elective video-assisted thoracoscopic surgery (VATS) lobectomy or segmentectomy; Planned postoperative admission to a general thoracic surgery ward; American Society of Anesthesiologists (ASA) physical status classification I-III; Capable of understanding questionnaires and verbal communication; Prospective cohort participants who voluntarily enroll in the study and provide written informed consent.
Who cannot join
- Emergency or trauma-related surgery; Planned direct postoperative admission to the intensive care unit (ICU); Severe cognitive impairment, delirium, or acute phase of psychiatric disorders; Severe hearing, speech or visual impairment precluding completion of assessments; Confirmed pregnancy or breastfeeding status; Chronic long-term use of sedative-hypnotics with unassessable baseline sleep status; Subjects deemed unlikely to complete key data collection or follow-up at the investigator's discretion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dynamic Prediction of First-Night Sleep Protection Needs After Thoracoscopic Lobectomy/Segmentectomy and Analysis of the Impact of Ward Routines
This study combines retrospective data analysis with a single-center prospective non-interventional cohort study to understand postoperative sleep disturbance on the first night after video-assisted thoracoscopic (VATS) lobectomy or segmentectomy. It mainly wants to answer the question: Can perioperative data collected along the clinical timeline dynamically predict which patients will experience clinically significant sleep disturbance on their first postoperative night? Participants undergoing elective VATS lung resection will have multidimensional data systematically collected from preoperative screening (including PSQI and GAD-7), intraoperative anesthetic parameters, PACU-to-ward handover, pre-bedtime symptom burden, and follow-up through 1 month. Three dynamic prediction models (M0 preoperative screening, M1 early postoperative update, and M2 pre-bedtime main model) will be developed using logistic regression with RCSQ-assessed sleep disturbance as the primary outcome, while an explanatory model will quantify the impact of nighttime disruptions such as intravenous infusions, vital sign monitoring, nursing entries, and awakenings.
Read the detailed description
This study combines retrospective data analysis with a single-center prospective non-interventional cohort study. The primary data collection is prospective, while retrospective data may be used for preliminary analysis or baseline comparison.
- Conditions
- Postoperative Sleep Disturbance
- Being tested
- Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy
- Keywords
- postoperative sleep disturbance, video-assisted thoracoscopic (VATS) lobectomy/segmentectomy, dynamic prediction model, ward workflow burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted thoracoscopic (VATS) lobectomy or segmentectomyProcedure or surgery
Standard elective video-assisted thoracoscopic (VATS) lobectomy or segmentectomy with general anesthesia and one-lung ventilation, performed according to routine institutional protocols. This is an observational study; no experimental modification is made to the surgical procedure, anesthetic management, or postoperative care. Patients receive standard thoracic ERAS care including analgesia, chest tube management, and vital sign monitoring. The procedure provides the clinical context for prospective perioperative data collection to develop dynamic prediction models for first-night sleep disturbance and analyze ward workflow impacts.
| Study group | Role | What they receive |
|---|---|---|
| Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy | Not described Receives: Procedure: Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant postoperative sleep disturbance on the first night after VATS lobectomy or segmentectomy
Clinically significant postoperative sleep disturbance (PSD) assessed by the Richards-Campbell Sleep Questionnaire (RCSQ) on postoperative day 1 morning. RCSQ contains 5 items (sleep depth, latency, awakenings, return to sleep, overall quality) scored 0-100; total score is the mean (higher=better). PSD defined as RCSQ total ≤50. First postoperative night: from PACU return to 06:00 next day (or actual return time if after 22:00). One missing item: mean of remaining four; ≥2 missing or inability to complete due to delirium/cognitive/communication barriers: invalid.
Measured: From PACU return to the general thoracic ward until 06:00 on postoperative day 1, assessed on the morning of postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start23 Jul 2026 (estimated)
- Primary completion22 Jul 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sleep DisturbanceStudies 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
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716085
- Sponsor's protocol ID
- KY-2026-165
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Prediction of First-Night Sleep Protection Needs After Thoracoscopic Lobectomy/Segmentectomy and Analysis of the Impact of Ward Routines
- ClinicalTrials.gov ID
- NCT07716085
- Acronym / sponsor ID
- KY-2026-165
- Conditions
- Postoperative Sleep Disturbance
- Keywords
- postoperative sleep disturbance, video-assisted thoracoscopic (VATS) lobectomy/segmentectomy, dynamic prediction model, ward workflow burden
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 23 Jul 2026 (estimated)
- Primary completion
- 22 Jul 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 21 Jul 2026 (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.
This study combines retrospective data analysis with a single-center prospective non-interventional cohort study to understand postoperative sleep disturbance on the first night after video-assisted thoracoscopic (VATS) lobectomy or segmentectomy. It mainly wants to answer the question: Can perioperative data collected along the clinical timeline dynamically predict which patients will experience clinically significant sleep disturbance on their first postoperative night? Participants undergoing elective VATS lung resection will have multidimensional data systematically collected from preoperative screening (including PSQI and GAD-7), intraoperative anesthetic parameters, PACU-to-ward handover, pre-bedtime symptom burden, and follow-up through 1 month. Three dynamic prediction models (M0 preoperative screening, M1 early postoperative update, and M2 pre-bedtime main model) will be developed using logistic regression with RCSQ-assessed sleep disturbance as the primary outcome, while an explanatory model will quantify the impact of nighttime disruptions such as intravenous infusions, vital sign monitoring, nursing entries, and awakenings.
Detailed description
This study combines retrospective data analysis with a single-center prospective non-interventional cohort study. The primary data collection is prospective, while retrospective data may be used for preliminary analysis or baseline comparison.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy | – | Procedure: Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years and older undergoing elective video-assisted thoracoscopic (VATS) lobectomy or segmentectomy within a single-center thoracic surgery perioperative care pathway. Participants are drawn from the routine inpatient population managed under standard enhanced recovery after surgery (ERAS) protocols, with planned postoperative admission to a general thoracic ward, ASA physical status I-III, capacity to understand and complete study questionnaires, and willingness to provide informed consent. The population encompasses the perioperative window from preoperative assessment through PACU recovery to the first postoperative night.
Key inclusion criteria (1 listed)
- Aged 18 years or older; Scheduled for elective video-assisted thoracoscopic surgery (VATS) lobectomy or segmentectomy; Planned postoperative admission to a general thoracic surgery ward; American Society of Anesthesiologists (ASA) physical status classification I-III; Capable of understanding questionnaires and verbal communication; Prospective cohort participants who voluntarily enroll in the study and provide written informed consent.
Key exclusion criteria (1 listed)
- Emergency or trauma-related surgery; Planned direct postoperative admission to the intensive care unit (ICU); Severe cognitive impairment, delirium, or acute phase of psychiatric disorders; Severe hearing, speech or visual impairment precluding completion of assessments; Confirmed pregnancy or breastfeeding status; Chronic long-term use of sedative-hypnotics with unassessable baseline sleep status; Subjects deemed unlikely to complete key data collection or follow-up at the investigator's discretion.
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 (VATS) lobectomy or segmentectomyStandard elective video-assisted thoracoscopic (VATS) lobectomy or segmentectomy with general anesthesia and one-lung ventilation, performed according to routine institutional protocols. This is an observational study; no experimental modification is made to the surgical procedure, anesthetic management, or postoperative care. Patients receive standard thoracic ERAS care including analgesia, chest tube management, and vital sign monitoring. The procedure provides the clinical context for prospective perioperative data collection to develop dynamic prediction models for first-night sleep disturbance and analyze ward workflow impacts. | Procedure or surgery | Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy |
Primary outcome
Clinically significant postoperative sleep disturbance on the first night after VATS lobectomy or segmentectomy
Time frame: From PACU return to the general thoracic ward until 06:00 on postoperative day 1, assessed on the morning of postoperative day 1
Clinically significant postoperative sleep disturbance (PSD) assessed by the Richards-Campbell Sleep Questionnaire (RCSQ) on postoperative day 1 morning. RCSQ contains 5 items (sleep depth, latency, awakenings, return to sleep, overall quality) scored 0-100; total score is the mean (higher=better). PSD defined as RCSQ total ≤50. First postoperative night: from PACU return to 06:00 next day (or actual return time if after 22:00). One missing item: mean of remaining four; ≥2 missing or inability to complete due to delirium/cognitive/communication barriers: invalid.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Sleep Disturbance, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
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: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruishi Yuan (+86 18726732268, police1872@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant postoperative sleep disturbance on the first night after VATS lobectomy or segmentectomy (time frame: From PACU return to the general thoracic ward until 06:00 on postoperative day 1, assessed on the morning of postoperative day 1). 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 21 Jul 2026.