Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-01-13 @ 10:34 AM
Study NCT ID:
NCT00464659
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2007-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008569', 'term': 'Memory Disorders'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, '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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2007-04-20', 'studyFirstSubmitQcDate': '2007-04-20', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep apnea obstructive syndrome (SAOS)', 'memory deficit', 'Continuous Positive Airway Pression (CPAP)', 'Sham CPAP'], 'conditions': ['Memory Deficit']}, 'referencesModule': {'references': [{'pmid': '11869421', 'type': 'BACKGROUND', 'citation': 'Beebe DW, Gozal D. Obstructive sleep apnea and the prefrontal cortex: towards a comprehensive model linking nocturnal upper airway obstruction to daytime cognitive and behavioral deficits. J Sleep Res. 2002 Mar;11(1):1-16. doi: 10.1046/j.1365-2869.2002.00289.x.'}, {'pmid': '15223874', 'type': 'BACKGROUND', 'citation': 'Engleman HM, Douglas NJ. Sleep. 4: Sleepiness, cognitive function, and quality of life in obstructive sleep apnoea/hypopnoea syndrome. Thorax. 2004 Jul;59(7):618-22. doi: 10.1136/thx.2003.015867.'}, {'pmid': '10209985', 'type': 'BACKGROUND', 'citation': 'Farre R, Hernandez L, Montserrat JM, Rotger M, Ballester E, Navajas D. Sham continuous positive airway pressure for placebo-controlled studies in sleep apnoea. Lancet. 1999 Apr 3;353(9159):1154. doi: 10.1016/S0140-6736(99)01056-9. No abstract available.'}, {'pmid': '16676787', 'type': 'BACKGROUND', 'citation': 'Naegele B, Launois SH, Mazza S, Feuerstein C, Pepin JL, Levy P. Which memory processes are affected in patients with obstructive sleep apnea? An evaluation of 3 types of memory. Sleep. 2006 Apr;29(4):533-44. doi: 10.1093/sleep/29.4.533.'}, {'pmid': '27810185', 'type': 'DERIVED', 'citation': 'Joyeux-Faure M, Naegele B, Pepin JL, Tamisier R, Levy P, Launois SH. Continuous positive airway pressure treatment impact on memory processes in obstructive sleep apnea patients: a randomized sham-controlled trial. Sleep Med. 2016 Aug;24:44-50. doi: 10.1016/j.sleep.2016.06.023. Epub 2016 Aug 23.'}, {'pmid': '26567858', 'type': 'DERIVED', 'citation': 'Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the evolution of memory deficit (verbal episodic memory, procedural memory, working memory, short-term memory) in Sleep Apnea Obstructive Syndrome (SAOS) patients after treatment by Continuous Positive Airway Pressure treatment (CPAP). For thus, we will compare memory tests in two separate groups of SAOS patients with "effective " versus "ineffective" ( or sham) CPAP, before and 6 weeks after the beginning of the treatment. Thus we will assess the evolution of memory deficit, the effectiveness of the treatment on the evolution of memory deficit before and 6 weeks after the beginning of the treatment by "effective " versus "ineffective" CPAP.\n\nWe feel the results of the tests of memory will show greater memory disorders in patients with SAOS before beginning the treatment rather than six weeks afterwards. Thus we hypothesise that, after the treatment by "effective" CPAP, the patients with SAOS will have greater improvement of their memory disorders than those treated by "sham CPAP".', 'detailedDescription': 'We want to assess the evolution, before and 6 weeks after the beginning of the treatment, of the significant differences of the performances of the various memory tests evaluating several forms of memory (episodic memory, working memory, short-term memory and procedural memory) according to the treatment for patients with SAOS (effective versus sham).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patients,\n* agreeing,\n* diagnosed suffering from the SAOS,\n* regulation by the specialist in a treatment by CPAP,\n* patients do not begin the treatment\n* affiliated to the social security,\n* fluent in French.\n\nExclusion Criteria:\n\n* Patients presenting severe depressive disorders (HADS score\\>19),\n* intellectual deterioration (MMS\\< 28),\n* a functional failure of the dominant arm upper limb inhibiting realization of graphic tasks,\n* an associated oxygen treatment,\n* suffering from cancer,\n* cerebro-vascular accident,\n* pregnant or nursing women,\n* adult under supervision or trusteeship,\n* patients already included in another research protocol or in period of exclusion,\n* antidepressant and anxiolytic treatment.'}, 'identificationModule': {'nctId': 'NCT00464659', 'briefTitle': 'Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Comparison of the Evolution of Memory Deficit in Patients With Sleep Apnea Obstructive Syndrome (SAOS) Before and After "Effective" Versus Sham Treatment by Positive Pression Continues (PPC)', 'orgStudyIdInfo': {'id': '0629'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Effective CPAP treatment', 'description': 'Effective Continuous Positive Airway Pressure treatment (CPAP) applied for 6 weeks', 'interventionNames': ['Device: Effective CPAP']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham CPAP treatment', 'description': 'Ineffective Continuous Positive Airway Pressure treatment (sham CPAP) applied for 6 weeks', 'interventionNames': ['Device: Sham CPAP']}], 'interventions': [{'name': 'Effective CPAP', 'type': 'DEVICE', 'description': 'Auto-titrating CPAP machines (Remstar Auto; Philips Respironics, Murrysville, PA) provided by a home care company (Bastide Medical, France). Pressure was set between 6 and 14 cm of water', 'armGroupLabels': ['Effective CPAP treatment']}, {'name': 'Sham CPAP', 'type': 'DEVICE', 'description': 'Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.', 'armGroupLabels': ['Sham CPAP treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'state': 'Isere', 'country': 'France', 'facility': 'Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean-Louis JP Pépin, ProfessorPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All individual patient data are anonymized'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}