Sleep Disorder, Lung TumorNCT05745506
Effect of Sleep Disorder on the Development of Lung Tumors
An observational study of Sleep Disorder, Lung Tumor, run by RenJi Hospital.
Trial summary
The goal of this observational study is to observe the lung tumor development in lung tumor patients with long-term sleep disorder. The main questions it aims to answer are: will long-term sleep disorder promote the malignancy of lung tumor if so, how exactly will the microenvironment of lung tumor change Participants… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Disorder, Lung Tumor
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Dec 2026
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Participants are 18-75 years old man or women diagnosed with primary lung tumor.
Who may be able to join
- 18-75 years old
- elective sublobectomy for primary lung tumor
- ASA grade I-II
- Informed consent of the patient or family
Who cannot join
- Combination of serious heart, liver, kidney, central nervous system, blood system, immune system diseases or serious mental illness
- Combination of other cancers
- untreated active lung infection
- patients with preoperative neoadjuvant radiotherapy
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: Effect of Sleep Disorder on the Development of Lung Tumors, a Perspective, Single-centered Study
The goal of this observational study is to observe the lung tumor development in lung tumor patients with long-term sleep disorder. The main questions it aims to answer are:
- will long-term sleep disorder promote the malignancy of lung tumor
- if so, how exactly will the microenvironment of lung tumor change Participants will receive PSQI scale and MRI functional brain imaging before surgery, blood and tumor tissue will be collected during the surgery.
Researchers will set non-sleep disorder group as control group to see if lung tumor microenvironment change when long-term sleep disorder exists in lung tumor patiens.
- Conditions
- Sleep Disorder, Lung Tumor
- Medical subject headings
- Sleep Wake Disorders, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Not applicable, there is no intervention description in this study.
| Study group | Role | What they receive |
|---|---|---|
| CRD | patients whose PSQI score>5 | |
| non-CRD | patients whose PSQI score ≦ 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor microenvironment in sleep-disordered lung cancer patients
we use single cell sequencing to analyze microenvironment alterations of tumor tissues in enrolled patients.
Measured: 3 months after surgery
Secondary outcomes (2)
peripheral blood levels of neurotransmitters in sleep-disordered lung cancer patients
peripheral blood levels of epinephrine, noradrenaline, 5-HT in sleep-disordered lung cancer patients
Measured: 3 months after surgery
Functional brain imaging in sleep-disordered lung cancer patients
Functional brain imaging
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder, Lung TumorStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weifeng Yu, Study director, Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745506
- Sponsor's protocol ID
- IIT-2022-0160
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep Disorder on the Development of Lung Tumors, a Perspective, Single-centered Study
- ClinicalTrials.gov ID
- NCT05745506
- Acronym / sponsor ID
- IIT-2022-0160
- Conditions
- Sleep Disorder, Lung Tumor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Feb 2023 (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.
The goal of this observational study is to observe the lung tumor development in lung tumor patients with long-term sleep disorder. The main questions it aims to answer are:
- will long-term sleep disorder promote the malignancy of lung tumor
- if so, how exactly will the microenvironment of lung tumor change Participants will receive PSQI scale and MRI functional brain imaging before surgery, blood and tumor tissue will be collected during the surgery.
Researchers will set non-sleep disorder group as control group to see if lung tumor microenvironment change when long-term sleep disorder exists in lung tumor patiens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRD | – | –patients whose PSQI score>5 |
| non-CRD | – | –patients whose PSQI score ≦ 5 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants are 18-75 years old man or women diagnosed with primary lung tumor.
Key inclusion criteria (4 listed)
- 18-75 years old
- elective sublobectomy for primary lung tumor
- ASA grade I-II
- Informed consent of the patient or family
Key exclusion criteria (4 listed)
- Combination of serious heart, liver, kidney, central nervous system, blood system, immune system diseases or serious mental illness
- Combination of other cancers
- untreated active lung infection
- patients with preoperative neoadjuvant radiotherapy
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 |
|---|---|---|
| Not applicable, there is no intervention description in this study. | Other | CRD, non-CRD |
Primary outcome
tumor microenvironment in sleep-disordered lung cancer patients
Time frame: 3 months after surgery
we use single cell sequencing to analyze microenvironment alterations of tumor tissues in enrolled patients.
2 secondary outcomes
peripheral blood levels of neurotransmitters in sleep-disordered lung cancer patients
Time frame: 3 months after surgery
Functional brain imaging in sleep-disordered lung cancer patients
Time frame: 3 months after surgery
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 27 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Sleep Disorder, Lung Tumor
Not yet recruiting
Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection
Sleep Wake Disorders, Lung Neoplasms
Not yet recruitingPhase 2
Low-Frequency rTMS for In-Hospital Sleep Disturbance in Advanced NSCLC
Carcinoma, Non-Small-Cell Lung, Sleep Wake Disorders
Recruiting
The Effects of Low-Intensity Endurance Exercise on Improving Fatigue, Sleep, Quality of Life, Mitochondrial Function, Cellular Bioelectrical Impedance Phase Angle, and Predictors of Exercise Adherence in Patients With Lung Cancer
Lung Cancer (Diagnosis)
Recruiting
Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer
Lung Neoplasm, Esophageal Neoplasms
RecruitingObservational study
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
Post-Acute COVID-19 Syndrome, ME/CFS
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.
Weifeng Yu study director
Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder, Lung Tumor, run by RenJi Hospital.
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 4 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: opening soon, as of the sponsor's last update on 27 Feb 2023. 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 Weifeng Yu (13901961704, ywf808@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor microenvironment in sleep-disordered lung cancer patients (time frame: 3 months after surgery). 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 27 Feb 2023.