Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-27 @ 1:37 PM
Study NCT ID:
NCT01873092
Status:
UNKNOWN
Last Update Posted:
2013-06-07
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-05', 'studyFirstSubmitDate': '2013-06-05', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ambulatory oximetry/activity profile', 'timeFrame': 'Data is collected over 30-34 consecutive hours', 'description': 'Oxygen saturation is measured with a pulse oximeter that has the capacity to collect data over 30- 34 hours; physical activity is measured with two pizo-electric accelerometers. Oximetry and activity data are synchronized to define a profile of oxygen saturation that is linked to usual daily activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oximetry', 'Physical Activity'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '20216326', 'type': 'RESULT', 'citation': 'Cohen MD, Cutaia M. A novel approach to measuring activity in chronic obstructive pulmonary disease: using 2 activity monitors to classify daily activity. J Cardiopulm Rehabil Prev. 2010 May-Jun;30(3):186-94. doi: 10.1097/HCR.0b013e3181d0c191.'}, {'pmid': '22409288', 'type': 'RESULT', 'citation': 'Cohen MD, Cutaia M, Brehm R, Brutus V, Pike VC, Lewendowski D. Detecting motor vehicle travel in accelerometer data. COPD. 2012 Apr;9(2):102-10. doi: 10.3109/15412555.2011.650238. Epub 2012 Mar 12.'}, {'pmid': '21701832', 'type': 'RESULT', 'citation': 'Cutaia M, Brehm R, Cohen M. The relationship of the BODE index to oxygen saturation during daily activities in patients with chronic obstructive pulmonary disease. Lung. 2011 Aug;189(4):269-77. doi: 10.1007/s00408-011-9308-1. Epub 2011 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'Chronic obstructive lung disease (COPD) is characterized by airflow obstruction that is progressive over many years and is largely irreversible. Advanced COPD is associated with arterial oxygen desaturation leading to a series of complications and, ultimately, decreased survival. Long-term oxygen therapy can improve clinical outcomes in these patients, but the exact target of oxygen saturation that actually translates into improvements is not known. The basis for the work in this proposal is to focus a new approach to measure oxygen desaturation linked to daily activity. Accelerometers are used to measure daily activity and then synchronized with ambulatory oximetry to establish an activity/oxygen-saturation profile for individual patients. The three main objectives of this study are 1) determine the feasibility of AOM as a measurement of the temporal profile of oxygen saturation in patients with chronic lung disease; 2) determine if serial AOM-derived data is reliable and reproducible; and 3) determine thresholds of oxygen desaturation that are associated with different activity profiles'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Veteran patients with chronic obstructive pulmonary disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Veteran patients with a diagnosis of COPD or other chronic lung disease\n2. able to read and understand English\n3. \\> 45 years old\n4. ambulatory and able to perform functional testing\n\nExclusion Criteria:\n\n1. unable or unwilling to give informed consent\n2. daily use of a motorized cart\n3. impairment of cognition or communication\n4. history of drug or alcohol treatment within the past 6 months\n5. poor peripheral blood flow to the finger rendering oxygen saturation by pulse oximetry unreliable\n6. Recent acute medical events (chest pain, discomfort, etc) that would suggest a contraindication to participate at the scheduled time'}, 'identificationModule': {'nctId': 'NCT01873092', 'briefTitle': 'AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients', 'organization': {'class': 'FED', 'fullName': 'VA New York Harbor Healthcare System'}, 'officialTitle': 'AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients', 'orgStudyIdInfo': {'id': '00493'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with COPD', 'description': 'Patients who meet criteria for chronic obstructive pulmonary disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11209', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'VA, New York Harbor Healthcare Service', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Miriam Cohen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA New York Harbor Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA New York Harbor Healthcare System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse Practitioner', 'investigatorFullName': 'Miriam D Cohen', 'investigatorAffiliation': 'VA New York Harbor Healthcare System'}}}}