Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-04 @ 2:12 PM
Study NCT ID:
NCT00262366
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2005-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-19', 'studyFirstSubmitDate': '2005-12-04', 'studyFirstSubmitQcDate': '2005-12-04', 'lastUpdatePostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring'}, {'measure': 'Arousal index'}, {'measure': 'Pressure profile Auto-CPAP (P50, P95 en Pmax)'}, {'measure': 'All outcomes are measured during polysomnography'}], 'secondaryOutcomes': [{'measure': 'Pressure adaptation during polysomnography according to body position and sleep stage, pressure variability'}, {'measure': 'Measurements of comfort, subjective evaluation by the patient by questionnaires immediately after polysomnography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Comparison of automatic CPAP with fixed CPAP in patients with OSAS', 'detailedDescription': 'The polysomnography is divided into two parts, randomly assigned:\n\n* in one part, the patient uses the automatic CPAP device in titration mode\n* in the other part, the patient uses the CPAP device, in fixed mode according to the prediction formula'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with proven Obstructive Sleep Apnea Syndrome\n* Apnea-hypopnea-index \\> 20/h\n* Awaking index \\> 30/h\n\nExclusion Criteria:\n\n* Severe nasal obstruction\n* Hypoventilation\n* Excessive sleep fragmentation caused by non-respiratory factors\n* COPD (FEV1/FVC \\< 65%)\n* CPAP compliance \\< 3h per night\n* Insufficient sleep time (\\< 2h TST) during one of both parts of the split night CPAP-titration\n* Patients needing \\> 16 mbar CPAP pressures'}, 'identificationModule': {'nctId': 'NCT00262366', 'briefTitle': 'Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS', 'orgStudyIdInfo': {'id': '2005/099'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Comparison of automatic CPAP versus fixed CPAP', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Dirk Pevernagie, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}}}}