Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery

NCT04759651 | Unknown

• 1 other identifier: 2020.482.IRB1.172
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to prospectively evaluate the occurrence of sleep disorders in patients undergoing thoracic surgery due to the preliminary diagnosis of lung cancer. Secondary aims include anxiety, depressive mood and functional outcomes before and 3 months after the intervention.

Conditions

Lung Cancer

Keywords

sleep disorder; vats; lung cancer; robotics; thoracoscopy

Outcome Measures

Primary Outcomes (6)

• Change from baseline in Functional Outcome of Sleep Questionnaire scores

  Sleep related quality of life. Score range: 5-20 points, with higher scores indicating better functional status.

  3 months

• Change from baseline in Epworth Sleepiness Scale scores

  Excessive daytime sleepiness. Score range: 0-24 points, with higher scores indicating greater daytime sleepiness. Scores ≥11 are generally considered to be abnormal, or positive for excessive daytime sleepiness.

  3 months

• Change from baseline in Berlin Questionnaire scores

  High-risk Obstructive Sleep Apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories.

  3 months

• Change from baseline in STOP-BANG questionnaire scores

  High-risk Obstructive Sleep Apnea. Score range: 0-8 points, patients with a STOP-Bang score of 0 to 2 can be classified as low risk for moderate to severe OSA whereas those with a score of 5 to 8 can be classified as high risk for moderate to severe OSA. The STOP-BANG is an assessment tool used to help diagnose Obstructive Sleep Apnea

  3 months

• Change from baseline in Insomnia questionnaire scores

  Insomnia questionnaire. Score range: 0-28 points, with higher scores indicating greater insomnia severity.

  3 months

• Change from baseline in Restless Legs Syndrome questionnaire scores

  Restless Leg Syndrome questionnaire. Score range: 0-4 points, with higher scores indicating more severe symptoms

  3 months

Secondary Outcomes (2)

• Change from baseline in Zung Self-rating Depression Scale scores

  3 months

• Change from baseline in Beck Anxiety Inventory scores

  3 months

Interventions

Functional Outcome of Sleep Questionnaire Turkish version (FOSQ-TR) OTHER

Sleep related quality of life questionnaire.

Epworth Sleepiness Scale (ESS) OTHER

Subjective level of daytime sleepiness.

Berlin Questionnaire OTHER

Evaluation of high-risk for Obstructive Sleep Apnea.

Stop-Bang Questionnaire OTHER

Evaluation of high-risk Obstructive Sleep Apnea.

Insomnia Questionnaire OTHER

Subjective evaluation of insomnia.

Restless Leg Syndrome Questionnaire OTHER

Subjective evaluation of Restless Leg Syndrome.

Zung Self-rating Depression Scale (SDS) OTHER

Subjective test for evaluation of depressive mood.

Beck Anxiety Inventory OTHER

Subjective test for evaluation of anxiety.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients meeting the criteria will be included in the study.

You may qualify if:

• Patients who will undergo lung resection with a pre-diagnosis of lung cancer
• Being literate or having the physical strength to answer questions.

You may not qualify if:

• The patient has a chronic disease such as dementia or treatment-resistant schizophrenia in which reality assessment is impaired.
• Patients who have received chemotherapy and / or radiotherapy due to their previous disease.

Sponsors & Collaborators

• Koç University: lead
• Marmara University: collaborator
• Trakya University: collaborator
• Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital: collaborator
• Yedikule Training and Research Hospital: collaborator
• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: collaborator

Study Sites (1)

Koç University Hospital

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Suat Erus, MD

CONTACT

+905325506947; serus@ku.edu.tr

Hale Yapıcı Eser, MD

CONTACT

+908502508250; hyapici@ku.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 18, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after the publication of the results
• Access Criteria: Data collected for the study, including de-identified individual participant data will be made available to others within 6 months after the publication of this article, as will additional related documents (study protocol, statistical analysis plan, and informed consent form), for academic purposes (e.g., meta-analyses), upon request to the corresponding author (serus@ku.edu.tr), and with a signed data access agreement.

Locations

TU (1)