Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-27 @ 1:45 PM
Study NCT ID:
NCT01424592
Status:
UNKNOWN
Last Update Posted:
2019-04-30
First Post:
2011-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-Hospital Portable Sleep Monitoring for the Evaluation of Obstructive Sleep Apnea (OSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-26', 'studyFirstSubmitDate': '2011-08-25', 'studyFirstSubmitQcDate': '2011-08-25', 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Portable sleep apnea testing', 'Positive airway pressure therapy', 'Polysomnography'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '27992566', 'type': 'RESULT', 'citation': 'Nagubadi S, Mehta R, Abdoh M, Nagori M, Littleton S, Gueret R, Tulaimat A. The Accuracy of Portable Monitoring in Diagnosing Significant Sleep Disordered Breathing in Hospitalized Patients. PLoS One. 2016 Dec 19;11(12):e0168073. doi: 10.1371/journal.pone.0168073. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Portable sleep testing of hospitalized medical inpatients suspected of having OSA is accurate in determining the need for positive airway pressure (PAP) therapy when compared to outpatient laboratory-based polysomnography.\n\n* Hospitalized medical inpatients referred for suspected OSA will be tested with a portable sleep apnea testing device during hospitalization.\n* These patients will then undergo an outpatient laboratory-based attended polysomnography after hospital discharge.\n* Results of the inpatient portable sleep apnea test will be compared to the outpatient laboratory-based polysomnography in terms of diagnostic accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the hospital under the general medicine service referred for evaluation of suspected obstructive sleep apnea.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Hospitalized inpatients referred for evaluation of suspected obstructive sleep apnea\n\nExclusion Criteria:\n\n* Patients admitted to surgical or obstetrics/gynecology services\n* Patients with certain medical conditions (altered mental status not related to respiratory failure, septicemia, unstable psychiatric disorder, narcotic abuse and prior diagnosed sleep apnea)\n* Patients with certain social histories (prisoners)\n* Patients unable to use CPAP (facial deformity and traumatic facial injuries).'}, 'identificationModule': {'nctId': 'NCT01424592', 'briefTitle': 'In-Hospital Portable Sleep Monitoring for the Evaluation of Obstructive Sleep Apnea (OSA)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Cook County Health'}, 'officialTitle': 'Inpatient Portable Sleep Apnea Testing of Hospitalized Medical Patients for the Evaluation of Obstructive Sleep Apnea Prospectively Compared to Outpatient Laboratory-based Polysomnography', 'orgStudyIdInfo': {'id': 'CCHHS IRB 11-027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'Hospitalized inpatients referred by a general medicine service for evaluation of obstructive sleep apnea.', 'interventionNames': ['Device: Testing with a portable sleep apnea monitor .']}], 'interventions': [{'name': 'Testing with a portable sleep apnea monitor .', 'type': 'DEVICE', 'otherNames': ['Alice PDx portable sleep testing system (Philips Respironics, Murraysville, PA)'], 'description': 'Portable sleep apnea testing will performed on referred patients.', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'John H Stroger Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Swamy Nagubadi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Attending Physician, Pulmonary, Critical Care and Sleep Medicine'}, {'name': 'Aiman Tulaimat, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Attending Physician, Pulmonary, Critical Care and Sleep Medicine'}, {'name': 'Rohit Mehta, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fellow Physician, Pulmonary, Critical Care and Sleep Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook County Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician: Pulmonary, Critical Care, and Sleep Medicine', 'investigatorFullName': 'Swamy Nagubadi', 'investigatorAffiliation': 'Cook County Health'}}}}