Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 4:59 PM
Study NCT ID:
NCT04903951
Status:
RECRUITING
Last Update Posted:
2024-08-12
First Post:
2021-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2021-05-17', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke.', 'timeFrame': '1 month after stroke'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) at 4 and 6 months after stroke.', 'timeFrame': '4 and 6 months after stroke'}, {'measure': 'Change from baseline in National Institutes of Health Stroke Scale (NIHSS) to measure improvement in neurological parameters at month 1, 4 and 6 after stroke.', 'timeFrame': '1, 4 and 6 months after stroke'}, {'measure': 'Type II full polysomnography (PSG II) within 7 days of stroke symptoms onset in all patients with AHI >5 as assessed by ApneaLink™', 'timeFrame': 'Within 7 days after admission'}, {'measure': 'Adherence in the Servoventilation group', 'timeFrame': 'After 1, 4 and 6 months', 'description': '% nights of device use; average hours per night of device use'}, {'measure': 'Efficacy in the Servoventilation group', 'timeFrame': 'After 1, 4 and 6 months', 'description': 'Apnea-Hypopnea Index'}, {'measure': 'Adverse events monitoring', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'All AEs occurring within the period of observation for the clinical study must be fully evaluated, documented, reported (if applicable) and archived.'}, {'measure': 'Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients', 'timeFrame': '1, 4 and 6 months after stroke'}, {'measure': 'Cardiovascular events evaluation 12 months after stroke in all participants.', 'timeFrame': '12 months after stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'early ventilation', 'sleep apnea'], 'conditions': ['Stroke', 'Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.', 'detailedDescription': 'Single-center, randomized, open label, parallel arm, prospective study in patients with sleep apnea after first-ever stroke.\n\nThe study will consist of screening, baseline assessment, interventional period (consisting of a treatment period and follow-up visits), and a follow-up phone call.\n\nPatients will be randomly assigned to ASV (active) or control groups, within 4 days after the PSG II and will start the respective intervention in the same day.\n\nPatients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated. Patients assigned to control group will receive best medical treatment for stroke alone, including rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent obtained from the participant or the legally acceptable representative, prior to any study-related procedure.\n2. Male or female between 18 and 80 years, inclusive, at the time of signing the informed consent.\n3. Admission to the hospital within 48 h of stroke symptoms onset.\n4. Ischemic first stroke diagnosis.\n5. NIHSS ≥2 at screening.\n6. Sleep apnea with AHI ≥15.\n\nExclusion Criteria:\n\n1. CSA with Left Ventricular Ejection Fraction ⩽45%.\n2. Ventilation treatment for sleep apnea diagnosis, prior to stroke.\n3. Risk of aspiration.\n4. Nasogastric feeding tube.\n5. Transient ischemic attack, hemorrhagic stroke or subarachnoid hemorrhage.\n6. Stroke due to a secondary cause (e.g. vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding).\n7. Cardiorespiratory distress.\n8. Advanced chronic lung disease requiring supplemental oxygen.\n9. Concomitant central nervous system diseases such as dementia or multiple sclerosis.\n10. Uncontrolled psychosis or agitation.\n11. Glasgow Coma Scale (GCS) score \\<10 at screening.\n12. Anosognosia, global or Wernicke aphasia.\n13. Insufficient upper limbs function to use a mask and no overnight caregiver to help.\n14. Inability to attend to the rehabilitation program of the hospital.\n15. Pregnant and breast-feeding women.\n16. Participation in another clinical study (except a standard-of-care registry).\n17. Any other condition that, according to the Investigator, renders the subject unsuitable for ventilation.'}, 'identificationModule': {'nctId': 'NCT04903951', 'briefTitle': 'Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Portuguesa S.A.'}, 'officialTitle': 'A Single-center, Randomized, Open Label, Parallel Arm, Prospective Study to Evaluate the Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke', 'orgStudyIdInfo': {'id': 'PSASV-01-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASV therapy + best medical treatment for stroke, including rehabilitation', 'description': 'Adaptive Servoventilation (ASV) therapy plus best medical treatment for stroke, including rehabilitation.', 'interventionNames': ['Device: Adaptive Servoventilation (ASV) therapy', 'Other: Best medical treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best medical treatment for stroke, including rehabilitation', 'description': 'Best medical treatment for stroke, including rehabilitation.', 'interventionNames': ['Other: Best medical treatment']}], 'interventions': [{'name': 'Adaptive Servoventilation (ASV) therapy', 'type': 'DEVICE', 'description': 'Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated', 'armGroupLabels': ['ASV therapy + best medical treatment for stroke, including rehabilitation']}, {'name': 'Best medical treatment', 'type': 'OTHER', 'description': 'Best medical treatment for stroke, including rehabilitation', 'armGroupLabels': ['ASV therapy + best medical treatment for stroke, including rehabilitation', 'Best medical treatment for stroke, including rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Matosinhos Municipality', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Sílvia Correia, MD', 'role': 'CONTACT'}], 'facility': 'Unidade Local de Saúde de Matosinhos', 'geoPoint': {'lat': 41.18207, 'lon': -8.68908}}], 'centralContacts': [{'name': 'Sílvia Correia, MD', 'role': 'CONTACT', 'email': 'silviapaiscorreia@gmail.com', 'phone': '00351969043466'}], 'overallOfficials': [{'name': 'Sílvia Correia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trofa Saúde Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Portuguesa S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sílvia Correia', 'investigatorAffiliation': 'Philips Portuguesa S.A.'}}}}