Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-04 @ 9:00 PM
Study NCT ID:
NCT04759651
Status:
UNKNOWN
Last Update Posted:
2022-04-15
First Post:
2021-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2021-02-01', 'studyFirstSubmitQcDate': '2021-02-14', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Functional Outcome of Sleep Questionnaire scores', 'timeFrame': '3 months', 'description': 'Sleep related quality of life. Score range: 5-20 points, with higher scores indicating better functional status.'}, {'measure': 'Change from baseline in Epworth Sleepiness Scale scores', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'Change from baseline in Berlin Questionnaire scores', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'Change from baseline in STOP-BANG questionnaire scores', 'timeFrame': '3 months', 'description': '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.\n\nThe STOP-BANG is an assessment tool used to help diagnose Obstructive Sleep Apnea'}, {'measure': 'Change from baseline in Insomnia questionnaire scores', 'timeFrame': '3 months', 'description': 'Insomnia questionnaire. Score range: 0-28 points, with higher scores indicating greater insomnia severity.'}, {'measure': 'Change from baseline in Restless Legs Syndrome questionnaire scores', 'timeFrame': '3 months', 'description': 'Restless Leg Syndrome questionnaire. Score range: 0-4 points, with higher scores indicating more severe symptoms'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Zung Self-rating Depression Scale scores', 'timeFrame': '3 months', 'description': 'Zung Self-rating Depression Scale. Score range: 0-80 points, most people with depression score between 50 and 69, while a score of 70 and above indicates severe depression.'}, {'measure': 'Change from baseline in Beck Anxiety Inventory scores', 'timeFrame': '3 months', 'description': 'Self-rating anxiety scale. Score range: 0-63 points, a total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep disorder', 'vats', 'lung cancer', 'robotics', 'thoracoscopy'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Cancer surgery is one of the traumas that affect human life, starting from diagnostic procedures, along with the recovery process. Although 5-year survival in lung cancer has increased to 60%, there is a general prejudice that lung cancer has a poor prognosis. A preliminary diagnosis of a such condition has consequently a negative effect on the mood and sleep patterns of the patients, starting already from the beginning of the diagnostic procedures. In our study, we want to evaluate the occurrence of sleep disorders, anxiety, depressive mood and functional outcomes before and 3 months after the surgical intervention. This would also help us to better identify the patients in need for professional support for sleep disorders as well as psychiatric conditions, and thus, a better management of patients with lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients meeting the criteria will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will undergo lung resection with a pre-diagnosis of lung cancer\n* Being literate or having the physical strength to answer questions.\n\nExclusion Criteria:\n\n* The patient has a chronic disease such as dementia or treatment-resistant schizophrenia in which reality assessment is impaired.\n* Patients who have received chemotherapy and / or radiotherapy due to their previous disease.'}, 'identificationModule': {'nctId': 'NCT04759651', 'briefTitle': 'Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Koç University'}, 'officialTitle': 'Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery: A Multicenter, Observational, Prospective Cohort Study', 'orgStudyIdInfo': {'id': '2020.482.IRB1.172'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Functional Outcome of Sleep Questionnaire Turkish version (FOSQ-TR)', 'type': 'OTHER', 'description': 'Sleep related quality of life questionnaire.'}, {'name': 'Epworth Sleepiness Scale (ESS)', 'type': 'OTHER', 'description': 'Subjective level of daytime sleepiness.'}, {'name': 'Berlin Questionnaire', 'type': 'OTHER', 'description': 'Evaluation of high-risk for Obstructive Sleep Apnea.'}, {'name': 'Stop-Bang Questionnaire', 'type': 'OTHER', 'description': 'Evaluation of high-risk Obstructive Sleep Apnea.'}, {'name': 'Insomnia Questionnaire', 'type': 'OTHER', 'description': 'Subjective evaluation of insomnia.'}, {'name': 'Restless Leg Syndrome Questionnaire', 'type': 'OTHER', 'description': 'Subjective evaluation of Restless Leg Syndrome.'}, {'name': 'Zung Self-rating Depression Scale (SDS)', 'type': 'OTHER', 'description': 'Subjective test for evaluation of depressive mood.'}, {'name': 'Beck Anxiety Inventory', 'type': 'OTHER', 'description': 'Subjective test for evaluation of anxiety.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34010', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Suat Erus', 'role': 'CONTACT', 'email': 'serus@ku.edu.tr', 'phone': '+908502508250', 'phoneExt': '29300'}], 'facility': 'Koç University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Suat Erus, MD', 'role': 'CONTACT', 'email': 'serus@ku.edu.tr', 'phone': '+905325506947'}, {'name': 'Hale Yapıcı Eser, MD', 'role': 'CONTACT', 'email': 'hyapici@ku.edu.tr', 'phone': '+908502508250'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '6 months after the publication of the results', 'ipdSharing': 'YES', 'description': '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, and with a signed data access agreement', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koç University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marmara University', 'class': 'OTHER'}, {'name': 'Trakya University School of Medicine', 'class': 'UNKNOWN'}, {'name': 'Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital', 'class': 'OTHER'}, {'name': 'Yedikule Training and Research Hospital', 'class': 'OTHER'}, {'name': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}