Effect of Sleep Disorder on the Development of Lung Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disorder, Lung Tumor
• Intervention / Treatment: Other

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Weifeng Yu; Phone Number: 13901961704; Email: ywf808@yeah.net
• Study Contact Backup: Name: Yumiao Shi; Phone Number: 19821850236; Email: shiyumiaoxka@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants are 18-75 years old man or women diagnosed with primary lung tumor.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CRD; patients whose PSQI score>5
non-CRD; patients whose PSQI score ≦ 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tumor microenvironment in sleep-disordered lung cancer patients	we use single cell sequencing to analyze microenvironment alterations of tumor tissues in enrolled patients.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months after surgery
Functional brain imaging in sleep-disordered lung cancer patients	Functional brain imaging	3 months after surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Director: Weifeng Yu, Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): June 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Neurologic Manifestations; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: IIT-2022-0160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED