Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-01 @ 2:45 PM
Study NCT ID:
NCT06000332
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2023-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-02', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-08-16', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number/% of subjects that could achieve SpO2 ≥90% for >30% of sleep time', 'timeFrame': '6 hours overnight', 'description': 'oxygen saturation (SpO2)'}], 'secondaryOutcomes': [{'measure': 'Number/% of subjects requiring increased settings and the difference between initial and maximal settings required to meet target SpO2 ≥90% for >30% of sleep time criteria', 'timeFrame': '6 hours overnight', 'description': 'oxygen saturation (SpO2)'}, {'measure': 'Time/% time above/below 90% target on initial setting and maximal setting', 'timeFrame': '6 hours overnight', 'description': 'oxygen saturation (SpO2)'}, {'measure': 'Number, duration, variability, and AUC of dips below 90% during sleep time on initial setting and maximal setting', 'timeFrame': '6 hours overnight', 'description': 'oxygen saturation (SpO2)'}, {'measure': 'Minimum/maximum SpO2 on initial setting and maximal setting', 'timeFrame': '6 hours overnight', 'description': 'oxygen saturation (SpO2)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hypoxemia, oxygen'], 'conditions': ['Nocturnal Hypoxemia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine whether the device can adequately maintain oxygen saturation during sleep.', 'detailedDescription': 'The study design is a prospective, single site, single arm, open label, pilot study. The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine whether the device can adequately maintain oxygen saturation during sleep, i.e., achieve target with initial titration setting and/or with any needed adjustments of setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects may be of any gender\n2. Subject's age must be 40 - 80 years\n3. Subjects must have a current prescription for nocturnal oxygen \\< 3 L/min continuous or current use of a Portable Oxygen Concentrator.\n\nExclusion Criteria:\n\n1. Subject is using any ancillary medical device(s) that may interfere with the operation of or data interpretation from the InogenOne device (such as CPAP/BiPAP, NIV).\n2. Subjects with nasal obstruction\n3. Subjects taking any drugs that affect respiratory center drive\n4. Subject has an acute illness or hospitalization within the last 30 days\n5. Subject has a change in medication within the last 15 days\n6. Subject is currently receiving respiratory stimulant medications (such as acetazolamide, medroxyprogesterone, doxapram, theophylline/aminophylline, protriptyline and buspirone)\n7. Subject has significant comorbidities that in the opinion of the Investigator would interfere with outcomes and/or study conduct\n8. Subject's prescribed treatment is in conflict with study procedures\n9. Subjects with any unstable disease"}, 'identificationModule': {'nctId': 'NCT06000332', 'briefTitle': 'Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inogen Inc.'}, 'officialTitle': 'Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia', 'orgStudyIdInfo': {'id': 'INO-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'InogenOne Rove 6 Portable Oxygen Concentrator', 'description': 'InogenOne Rove 6 Portable Oxygen Concentrator', 'interventionNames': ['Device: InogenOne Rove 6 Portable Oxygen Concentrator']}], 'interventions': [{'name': 'InogenOne Rove 6 Portable Oxygen Concentrator', 'type': 'DEVICE', 'description': 'overnight use of Portable Oxygen Concentrator, 6 hours minimum', 'armGroupLabels': ['InogenOne Rove 6 Portable Oxygen Concentrator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28625', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Piedmont Healthcare', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}], 'overallOfficials': [{'name': 'Stanislav Glezer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inogen Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inogen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}