Effect of Sleep Disorder on the Development of Lung Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 18-75 years old.

- elective sublobectomy for primary lung tumor.

- ASA grade I-II.

- Informed consent of the patient or family.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05745506
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	RenJi Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Weifeng Yu
Principal Investigator Affiliation	Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sleep Disorder, Lung Tumor

Arms & Interventions

Arms

: CRD

patients whose PSQI score>5

: non-CRD

patients whose PSQI score ≦ 5

Interventions

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Weifeng Yu

[email protected]

13901961704

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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