Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04848012
Status:
SUSPENDED
Last Update Posted:
2024-04-03
First Post:
2021-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of an Advanced Auto-titrating NIV in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '12 weeks sequential (pre/post) study. Participants will receive usual NIV treatment for 6 weeks followed by novel ventilator for 6 weeks.\n\nThere will be a randomised crossover element for one night at the midpoint of the study to assess sleep parameters on the two ventilation modalities.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'whyStopped': 'Awaiting change to device under investigation', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-04-15', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to ventilation therapy', 'timeFrame': '6 weeks', 'description': 'Number of hours spent on nocturnal ventilation therapy'}], 'secondaryOutcomes': [{'measure': 'Mean nocturnal transcutaneous carbon dioxide level', 'timeFrame': '1 night during single night admission', 'description': 'Mean nocturnal transcutaneous carbon dioxide level measured on single night admission'}, {'measure': 'Maximal nocturnal transcutaneous carbon dioxide level', 'timeFrame': '1 night during single night admission', 'description': 'Maximal nocturnal transcutaneous carbon dioxide level measured on single night admission'}, {'measure': 'Sleep parameters', 'timeFrame': '1 night during single night admission', 'description': 'Sleep efficiency, measured by polysomnography'}, {'measure': 'Sleep parameters', 'timeFrame': '1 night during single night admission', 'description': 'Wake after sleep onset, measured by polysomnography'}, {'measure': 'Sleep parameters', 'timeFrame': '1 night during single night admission', 'description': 'Time in rapid eye movement/non rapid eye movement sleep, measured by polysomnography'}, {'measure': 'Sleep parameters', 'timeFrame': '1 night during single night admission', 'description': 'Apnoea/hypopnoea index, measured by polysomnography'}, {'measure': 'Sleep parameters', 'timeFrame': '1 night during single night admission', 'description': '4 per cent oxygen desaturation index, measured by polysomnography'}, {'measure': 'Inspiratory capacity', 'timeFrame': '6 weeks', 'description': 'Inspiratory capacity following 6 weeks of each NIV device'}, {'measure': 'Health-related quality of life', 'timeFrame': '6 weeks', 'description': 'Measured using COPD Assessment Test'}, {'measure': 'Health-related quality of life', 'timeFrame': '6 weeks', 'description': 'Measured using Severe Respiratory Insufficiency Questionnaire'}, {'measure': 'Daytime physical activity', 'timeFrame': '2 weeks', 'description': 'Measured using wrist actigraphs during the final 2 weeks of each 6 week arm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease Severe']}, 'descriptionModule': {'briefSummary': 'Patients with chronic obstructive pulmonary disease (COPD) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. Non-invasive ventilation (NIV) is a ventilator therapy that is used in COPD patients who suffer from respiratory failure. Studies have demonstrated that using NIV at night regularly can result in improved clinical outcomes.\n\nAdherence to this therapy is variable, however. This can be due to poor synchrony between the device and the lungs. A novel ventilator has been designed that delivers NIV but is also incorporated with technology to assess for aberrations in respiratory physiology and correct them, breath-by-breath.\n\nThe investigators aim to assess the efficacy, safety and tolerability of this novel ventilator. The primary research question is whether the novel ventilator can improve adherence to therapy, when compared with the usual ventilator.\n\nPatients with COPD who use ventilation at home will be screened for inclusion in the study. Participation will involve a screening visit, and a further two visits to the Lane Fox Respiratory Unit. The first will require a two-night admission and the second a single-night admission. They will undergo detailed assessment of their daytime and overnight respiratory and sleep physiology during these admissions. These visits will be separated by a six-week period during which they will be asked to use the novel ventilator at home.\n\nPatients will be recruited into a sub-study to evaluate the performance of the ventilator in a daytime physiological assessment. This will involve detailed invasive physiological assessment of expiratory flow limitation and how the machine is able to adjust settings to optimise respiratory support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* Age ≥ 18 years\n* BMI \\<30 kg/m¬2\n* Confirmed diagnosis of COPD\n* Currently using domiciliary NIV with average reported compliance of at least 3hours\n* Ability to provide informed consent\n* Medical stability confirmed by recruiting physician\n* Free of exacerbations for at least 2 weeks prior to enrolment\n* Presence of expiratory flow limitation on forced oscillation technique criteria\n\nExclusion Criteria:\n\n* Current acute illness as determined by recruiting physician e.g. upper respiratory tract infection\n* Presence of major medical comorbidity, e.g. severe heart failure (LVEF \\<30%), active malignancy, end-stage renal failure (CKD 4), and neuromuscular disease\n* Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.\n* Psychosocial factors that would prevent compliance with study protocol\n\nHealthy participant inclusion criteria:\n\n* Age ≥ 18 years\n* No expiratory flow limitation on forced oscillation testing\n* No acute illness on study day\n* Ability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04848012', 'briefTitle': 'Efficacy of an Advanced Auto-titrating NIV in COPD', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Clinical Validation, Safety & Efficacy Study of an Advanced Auto-titrating Non-invasive Ventilator in Patients With Severe Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '279564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual non-invasive ventilation', 'description': 'The usual therapy the participant is receiving via non-invasive ventilator.'}, {'type': 'EXPERIMENTAL', 'label': 'Auto-titrating non-invasive ventilation', 'description': 'A novel auto-titrating non-invasive ventilator', 'interventionNames': ['Device: Auto-titrating non-invasive ventilation']}], 'interventions': [{'name': 'Auto-titrating non-invasive ventilation', 'type': 'DEVICE', 'description': 'A non-invasive ventilator designed to auto-adjust the expiratory positive airway pressure according to expiratory flow limitation, measured using the forced oscillation technique.', 'armGroupLabels': ['Auto-titrating non-invasive ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Guys and St Thomas NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Neeraj Shah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}, {'name': 'Nicholas Hart', 'role': 'STUDY_CHAIR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}, {'name': 'Patrick Murphy', 'role': 'STUDY_DIRECTOR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}