Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT03421704
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020182', 'term': 'Sleep Apnea, Central'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D002639', 'term': 'Cheyne-Stokes Respiration'}], 'ancestors': [{'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': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short term Device usage and therapy adherence', 'timeFrame': '6 months', 'description': 'Device usage (hours/ night). Patients will be classified into various adherence subgroups based on the average daily device use at each study interval. The percentage of participants in each of the adherence subgroups will be presented.'}], 'secondaryOutcomes': [{'measure': 'Long term Device usage and therapy adherence', 'timeFrame': '12 months', 'description': 'EDevice usage (hours/ night). Patients will be classified into various adherence subgroups based on the average daily device use at each study interval. The percentage of participants in each of the adherence subgroups will be presented.'}, {'measure': 'Change in Health-related quality of life', 'timeFrame': '6, 12 and 24 months', 'description': 'European Quality of Life-5 Dimensions questionnaire EQ 5D- 5L) is a standardized instrument for measuring generic health related quality of life. This tools scores range from 1 to 5, with higher scores indicating more problems across five dimensions (5D) which comprise mobility, self-care, usual activities, pain/discomfort, and anxiety/depression'}, {'measure': 'Change in Subjective sleep quality', 'timeFrame': '6, 12 and 24 months', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Change in Daytime sleepiness.', 'timeFrame': '6, 12 and 24 months', 'description': 'Epworth Sleepiness Scale (ESS). This test consists of eight questions of daily life activities with a number from 0 (not at all likely to fall asleep) to 3 (very likely to fall asleep) which yields a score of 0 to 24, and subjectively quantify sleepiness.25 An ESS score ranging from 0 to 10 is interpreted as normal, scores of 11 to 24 is considered to be abnormal and indicative of increasing levels of excessive daytime sleepiness.'}, {'measure': 'Change on PSG/PG Parameters from baseline', 'timeFrame': '6 months', 'description': 'Disordered breathing events'}, {'measure': 'Change on PSG/PG Parameters from baseline', 'timeFrame': '6 months', 'description': 'Quality of Sleep'}, {'measure': 'Mortality', 'timeFrame': '6, 12 and 24 months', 'description': 'Frequency of death in patients who showed adherence to therapy as compared to those with non-adherence'}, {'measure': 'Causes of death', 'timeFrame': '6, 12 and 24 months', 'description': 'causes of death , if available, will be compared in patients who showed adherence to therapy as compared to those with non-adherence'}, {'measure': 'Number of healthcare utilization', 'timeFrame': '6, 12 and 24 months', 'description': "Number of hospitalizations during the minimum of one year follow-up, time to first hospitalization, composite number of unscheduled visits to emergency rooms and/or physician's office) in patients who showed adherence to therapy as compared to those with non-adherence (if data is available)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Central Sleep Apnea', 'Mixed Sleep Apnea', 'Cheyne-Stokes Respiration', 'Complex Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This multi-center observational study will prospectively collect data from patients who have an indication for servo ventilation therapy. This registry is intended to characterize the patient populations that may benefit from DreamStation BiPAP autoSV therapy (PR DS-autoSV, Philips Respironics, Monroeville, PA) in real life settings. In addition, this registry will assess adherence to the PR DS-autoSV therapy, the therapeutic benefits, collect morbidity and mortality data of servo ventilation in patients with central sleep apnea (CSA) and complex sleep-disordered breathing (SDB).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The registry will include adult participants with indication and prescription of PR DS-autoSV', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication and prescription of PR DS-autoSV\n* Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation\n\nExclusion Criteria:\n\n* Patients with HFrEF - heart failure and low ejection fraction (EF ≤ 45%) and predominant CSA (\\> 50 % of events)\n* Patients not able to receive positive airway pressure support through a mask due to surgical procedure or anatomical condition\n* Chronic conditions with life expectancy \\< 1 year\n* Significant chronic obstructive pulmonary disease (COPD) with an FEV1/VC \\< 70% (GOLD III)\n* Respiratory insufficiency requiring long-term oxygen therapy\n* Daytime hypercapnia at rest (pCO2 \\> 45 mmHg)\n* Cardiac surgery, PCI, myocardial infarction, unstable angina, within 12 weeks prior to enrolment\n* Cardiac resynchronization or pacemaker implantation within the last 6 months\n* Untreated or therapy refractory Restless legs-Syndrome (RLS)'}, 'identificationModule': {'nctId': 'NCT03421704', 'acronym': 'autoSVREGDE', 'briefTitle': 'A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Respironics'}, 'officialTitle': 'A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.', 'orgStudyIdInfo': {'id': 'SRC-SLE-ASVREGDE-2017-10032'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DreamStation BiPAP autoSV', 'type': 'DEVICE', 'description': 'Philips Respironics DreamStation BiPAP autoSV (PR DS-autoSV) is designed to deliver pressure support for patient ventilatory assistance'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Universitätsklinikum der Ruhr-Universität Bochum', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Donaustauf', 'country': 'Germany', 'facility': 'Klinik Donaustauf', 'geoPoint': {'lat': 49.03258, 'lon': 12.20459}}, {'zip': '6058091', 'city': 'Hagen', 'country': 'Germany', 'facility': 'Helios Klinik Hagen Ambrok', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Muenster University Hospital', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'University Hospital Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Schmallenberg', 'country': 'Germany', 'facility': 'Fachkrankenhaus Kloster', 'geoPoint': {'lat': 51.15473, 'lon': 8.28505}}, {'zip': '19049', 'city': 'Schwerin', 'country': 'Germany', 'facility': 'Helios Kliniken Schwerin', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}, {'zip': '42699', 'city': 'Solingen', 'country': 'Germany', 'facility': 'Wissenschaftliches Institut Bethanien für Pneumologie e.V', 'geoPoint': {'lat': 51.17343, 'lon': 7.0845}}], 'overallOfficials': [{'name': 'Michael Arzt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Regensburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Respironics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}