Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT00918502
Status:
COMPLETED
Last Update Posted:
2010-02-04
First Post:
2009-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitor Patients With Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-02', 'studyFirstSubmitDate': '2009-06-10', 'studyFirstSubmitQcDate': '2009-06-10', 'lastUpdatePostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Apnea']}, 'descriptionModule': {'briefSummary': "The primary objective of the study is to gather data to correlate physiological signals measured by the AVIVO™ Mobile Patient Management System with the patient's respiratory status, including apnea and hypopnea events, during polysomnography", 'detailedDescription': "Patients with suspected sleep disordered breathing will be monitored during polysomnography and the collected information will be used to assess patient's respiratory status."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'sleep study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is female or male, 18 years of age or older\n* Undergoing polysomnography for suspected sleep apnea\n* Is willing to provide written informed consent and comply with study guidelines'}, 'identificationModule': {'nctId': 'NCT00918502', 'acronym': 'ARMADA', 'briefTitle': 'Monitor Patients With Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corventis, Inc.'}, 'officialTitle': 'Adherent Respiratory Monitoring for Apnea Detection and Evaluation Study', 'orgStudyIdInfo': {'id': 'COR-2009-004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AVIVO system', 'type': 'DEVICE', 'description': 'Non invasive external monitoring device'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Imad Libbus, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corventis, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corventis, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Madhuri Bhat, VP Regulatory and Clinical affairs', 'oldOrganization': 'Corventis'}}}}