Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT02764866
Status:
COMPLETED
Last Update Posted:
2017-11-09
First Post:
2016-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Apnea in Lung Cancer: A Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], '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': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-08', 'studyFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of sleep disordered breathing in lung cancer', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Survival of lung cancer in patients with sleep disordered breathing', 'timeFrame': '36 months'}, {'measure': 'Lung cancer stage in patients with sleep disordered breathing', 'timeFrame': '12 months'}, {'measure': 'Lung cancer progression free survival in patients with sleep disordered breathing', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung cancer', 'Sleep apnea', 'Sleep disordered breathing'], 'conditions': ['Lung Cancer', 'Sleep-Disordered Breathing']}, 'referencesModule': {'references': [{'pmid': '31605903', 'type': 'DERIVED', 'citation': 'Seijo LM, Perez-Warnisher MT, Giraldo-Cadavid LF, Oliveros H, Cabezas E, Troncoso MF, Gomez T, Melchor R, Pinillos EJ, El Hachem A, Gotera C, Rodriguez P, Gonzalez-Mangado N, Peces-Barba G. Obstructive sleep apnea and nocturnal hypoxemia are associated with an increased risk of lung cancer. Sleep Med. 2019 Nov;63:41-45. doi: 10.1016/j.sleep.2019.05.011. Epub 2019 Jun 6.'}], 'seeAlsoLinks': [{'url': 'http://www.lungscreen.eu', 'label': 'Lung cancer screening home web page'}]}, 'descriptionModule': {'briefSummary': 'The study seeks to determine the prevalence of sleep disordered breathing in a population of patients diagnosed with lung cáncer.', 'detailedDescription': 'Obstructive sleep apnea hypopnea syndrome (OSAHS) is an important medical condition which causes significant morbidity and mortality. The prevalence of OSAHS in Spain is 4-6% in men and 2-4% in women and rises steadily with age. Snoring and smoking have been independently linked, and smoking may be a risk factor for developing OSAHS. This is particularly true of heavy smokers (\\> 2 packs/day), those at greatest risk for LC. Associations between OSAHS and some forms of cancer have been described in humans, especially in those experiencing nocturnal hypoxemia, and intermittent hypoxia has been linked to the progression of cancer in animal models. LC is currently the leading cause of cancer deaths in developped nations. A link between OSAHS and LC, therefore, is plausible.\n\nSleep disordered breathing may be common among patients recently diagnosed of lung cancer and may contribute to tumor progression.\n\nObjectives: a) To perform home sleep testing in patients recently diagnosed with lung cancer in order to determine the prevalence of sleep disordered breathing in this patient population. b) To include biological samples obtained from all participants, including surgically treated patients with stage I / IIp LC through the program in the CIBERES Pulmonary Biobank Platform. Biological samples will be preserved under different storage conditions for subsequent determination of molecular biomarkers. c) To follow-up lung cancer patients with and without sleep disordered breathing in order to determine the potential influence OSAHS might have on their prognosis.\n\nProspective screening for sleep disordered breathing will be performed by home sleep testing in 100 subjects diagnosed with lung cancer, irrespective of stage at diagnosis, who give their consent. A modified epidemiologic questionnaire for sleep disordered breathing will also be administered. Patients identified as suffering from OSAHS will be referred to sleep clinic. Biologic samples and lung function studies will be obtained in all participating patients.\n\nAll patients with lung cancer will undergo follow-up for at least three years or until their demise, and those identified with OSAHS will also be followed in sleep clinic. The prevalence of OSAHS in this patient population will be determined. A link between OSAHS, and especially intermittent nocturnal hypoxemia, and tumor progression will be sought.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with recently diagnosed lung cancer, inlcuding all stages of disease.\n\nExclusion Criteria:\n\n* Patients unable to comply with home sleep testing.'}, 'identificationModule': {'nctId': 'NCT02764866', 'acronym': 'SAIL', 'briefTitle': 'Sleep Apnea in Lung Cancer: A Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz'}, 'officialTitle': 'Prevalence of Sleep Apnea in Lung Cancer', 'orgStudyIdInfo': {'id': 'InstitutoFJD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep testing', 'description': 'Enrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment.', 'interventionNames': ['Other: Sleep testing']}], 'interventions': [{'name': 'Sleep testing', 'type': 'OTHER', 'description': 'Home sleep testing', 'armGroupLabels': ['Sleep testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Luis M Seijo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Investigacion Fundacion Jimenez Diaz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'LUIS SEIJO MACEIRAS', 'investigatorAffiliation': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz'}}}}