Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT03506906
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2018-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D010845', 'term': 'Obesity Hypoventilation Syndrome'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}], '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': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007040', 'term': 'Hypoventilation'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003955', 'term': 'Diagnostic Tests, Routine'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2018-04-12', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjustment of non-invasive ventilation', 'timeFrame': 'One day', 'description': "Each case will be evaluated separately by 2 investigators. One of them will be provided with the diurnal evaluations only (as routinely); the second investigator will additionally have access to the sleep studies. Each investigator will classify the case as one of the following labels (primary outcome):\n\n1. Non-invasive ventilation therapy optimization is not required (all ventilator's parameters should stay unchanged)\n2. Optimization of non-invasive ventilation therapy is required (one or more of the ventilator's parameters should be re-set, irrespective of the magnitude)"}], 'secondaryOutcomes': [{'measure': 'Non-invasive ventilation compliance', 'timeFrame': '6 months', 'description': "The ventilator's optimization will be performed randomly according to the clinical-based approach or the sleep studies-based approach. In the next follow-up visit, both arms will be re-evaluated. The change in non-invasive ventilation therapy compliance will be explored based on the ventilator´s built-in software data."}, {'measure': 'Health-related quality of life: questionnaire', 'timeFrame': '6 months', 'description': 'In the next follow-up visit, the health-related quality of life of both groups will be evaluated with the severe respiratory insufficiency questionnaire.'}, {'measure': 'arterial level of carbon dioxide', 'timeFrame': '6 months', 'description': 'In the next follow-up visit, the arterial level of carbon dioxide of both groups will be evaluated in the blood gas analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic hypoventilation syndrome', 'Polysomnography', 'Transcutaneous Capnometry', 'Noninvasive Ventilation', 'home mechanical ventilation', 'Ventilator´s set-up'], 'conditions': ['Hypoventilation Syndrome', 'Chronic Obstructive Pulmonary Disease', 'Obesity Hypoventilation Syndrome', 'Restrictive Lung Disease', 'Neuromuscular Diseases']}, 'descriptionModule': {'briefSummary': "Patients suffering chronic hypercapnic respiratory insufficiency (e.g. in chronic obstructive pulmonary disease, obesity hypoventilation syndrome) benefit from home mechanical ventilation. These patients are complex; and the ventilator´s parameters should be set-up according to the underlying disease and particular patient's characteristics. The non-invasive ventilation therapy is mostly titrated while the patient is awake, hence Problems, such as Patient-Ventilator asynchrony, arising while sleeping on the ventilator therapy would remain undetected.\n\nSleep studies, such as polysomnography or polygraphy and transcutaneous carbon dioxide monitoring could be valuable tools to fine-tune the ventilator's settings. This could foster the ventilator´s effectivity and patient satisfaction, thus therapy's adherence. Nevertheless the sleep studies are expensive, time-consuming and not widely available.\n\nThe aim of this study is to learn the findings of sleep studies when they are performed on stable patients on home mechanical ventilation as part of their routine check-ups. In this context, it will be assessed whether the sleep studies' findings lead to a change (adjustment) of the ventilator´s therapy. Moreover, this study aims to investigate whether the absence of sleep studies would result in missing important events that require an adjustment of therapy. The results of this study could provide information that lead to a more standardized protocol of follow-up checks of patients on home mechanical ventilation in a cost-effective manner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with chronic hypercapnic respiratory failure secondary to one or more identified condition(s) (chronic obstructive pulmonary disease, obesity hypoventilation syndrome, neuromuscular diseases, restrictive lung diseases)\n* Home mechanical ventilation for ≥ 6 months\n* Stable condition for ≥ 1 month\n\nExclusion Criteria:\n\n* Previous adjustment of the noninvasive ventilation therapy under sleep studies in the last 6 months\n* Current respiratory exacerbation\n* Any current comorbidity decompensation\n* Any medical or psychological condition impairing the patient's ability to provide informed consent\n* Missing signed informed consent\n* Total sleep time during polysomnography \\<180 min"}, 'identificationModule': {'nctId': 'NCT03506906', 'briefTitle': 'The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Wissenschaftliches Institut Bethanien e.V'}, 'officialTitle': 'The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'WI_18-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional-approach', 'description': "The non-invasive ventilation therapy will be optimized according to routine tests (blood gas analysis, lung function, ventilator's built-in software analysis)", 'interventionNames': ['Diagnostic Test: Routine tests']}, {'type': 'EXPERIMENTAL', 'label': 'Sleep studies-based approach', 'description': 'Additionally to the routine tests, the results of a nocturnal polysomnography and transcutaneous capnometry under the non-invasive ventilation therapy will be considered for the therapy optimization.', 'interventionNames': ['Diagnostic Test: Sleep studies under noninvasive ventilation therapy', 'Diagnostic Test: Routine tests']}], 'interventions': [{'name': 'Sleep studies under noninvasive ventilation therapy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Polysomnography Transcutaneous capnography', 'armGroupLabels': ['Sleep studies-based approach']}, {'name': 'Routine tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Spirometry, six minute walk test, blood gas analysis, questionnaires (Epworth sleepiness score, health related quality of life severe respiratory insufficiency questionnaire)', 'armGroupLabels': ['Conventional-approach', 'Sleep studies-based approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42699', 'city': 'Solingen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Krankenhaus Bethanien', 'geoPoint': {'lat': 51.17343, 'lon': 7.0845}}], 'overallOfficials': [{'name': 'Winfried J Randerath, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krankenhaus Bethanien'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wissenschaftliches Institut Bethanien e.V', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}