Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 1:20 PM
Study NCT ID:
NCT01505959
Status:
UNKNOWN
Last Update Posted:
2014-09-05
First Post:
2012-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D001049', 'term': 'Apnea'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 936}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-04', 'studyFirstSubmitDate': '2012-01-05', 'studyFirstSubmitQcDate': '2012-01-06', 'lastUpdatePostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure evolution by comparing baseline and 6 months measurements', 'timeFrame': 'day 0 and month 6', 'description': 'Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days)'}], 'secondaryOutcomes': [{'measure': 'Objective CPAP compliance at 6 months', 'timeFrame': 'day 0 and month 6', 'description': 'CPAP compliance assessed after 6 months in the two groups'}, {'measure': 'Diastolic blood pressure evolution by comparing baseline and 6 months', 'timeFrame': 'day 0 and month 6', 'description': 'Diastolic blood pressure is assessed at day 0 and month 6 in the two groups'}, {'measure': 'Subjective Sleepiness', 'timeFrame': 'inclusion and month 6', 'description': 'Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups'}, {'measure': 'Fatigue', 'timeFrame': 'inclusion and month 6', 'description': 'Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups'}, {'measure': 'Quality of Life', 'timeFrame': 'inclusion and month 6', 'description': 'Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups'}, {'measure': 'Health status', 'timeFrame': 'inclusion and month 6', 'description': 'Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups'}, {'measure': 'Physical activity', 'timeFrame': 'inclusion and month 6', 'description': 'Physical activity is assessed with actimetry at inclusion and month 6 in the two groups'}, {'measure': 'Cost analysis', 'timeFrame': 'month 6', 'description': 'Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea Syndrome', 'Apnea', 'Sleep Apnea', 'Telemedicine', 'CPAP compliance'], 'conditions': ['Sleep Apnea Syndromes', 'High Cardiovascular Risk']}, 'descriptionModule': {'briefSummary': 'Targeted population:\n\nSleep apnea patients at high cardiovascular risk newly treated by CPAP\n\nHypothesis:\n\nImprovement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care.\n\nMain goal:\n\nTo compare 6-months blood pressure reduction when Sleep Apnea patients at high cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.', 'detailedDescription': 'Study procedures:\n\nThe telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of home self-measured blood pressure, oximetry, physical activity recorded by actigraphy, CPAP compliance, side effects and residual events.\n\nSecured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events.\n\nAn interim analysis will be performed when 300 patients will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 to 78 years\n* Men and women\n* AHI \\> 30 / hour\n* Patient with high cardiovascular score (\\>5% defined by European SCORE) or known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)\n* Patient affiliated to the National health insurance\n* Willingness to use a telemonitoring system\n\nExclusion Criteria:\n\n* Central sleep apnea syndrome\n* Previous CPAP treatment with respiratory support for sleep respiratory trouble\n* Cardiac failure with left ventricular ejection fraction lesser than 40%\n* Hypercapnic chronic respiratory failure (daytime PaCO2 \\> 50 mmHg)\n* Terminal disease'}, 'identificationModule': {'nctId': 'NCT01505959', 'briefTitle': 'Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study', 'organization': {'class': 'OTHER', 'fullName': 'Fédération Française de Pneumologie'}, 'officialTitle': 'Blood Pressure Reduction Induced by Continuous Positive Airway Pressure (CPAP) in Sleep Apnea Patients at High Cardiovascular Risk : A Randomized Controlled Trial Comparing Usual CPAP Care Versus a Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform', 'orgStudyIdInfo': {'id': '11-FFPO-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional', 'interventionNames': ['Device: CPAP treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telemedicine', 'interventionNames': ['Device: CPAP treatment']}], 'interventions': [{'name': 'CPAP treatment', 'type': 'DEVICE', 'description': 'Usual CPAP treatment', 'armGroupLabels': ['Conventional']}, {'name': 'CPAP treatment', 'type': 'DEVICE', 'description': 'CPAP treatment with telemedicine system', 'armGroupLabels': ['Telemedicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73200', 'city': 'Albertville', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique LIGEONNET, MD', 'role': 'CONTACT'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 45.67452, 'lon': 6.39061}}, {'zip': '74000', 'city': 'Annecy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François BON, MD', 'role': 'CONTACT'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc SAPENE, MD', 'role': 'CONTACT'}, {'name': 'François PELLET, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laurent FALQUE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vincent PUEL, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nathalie RAYMOND, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christophe SUREAU, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '06401', 'city': 'Cannes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe PERRIN, MD', 'role': 'CONTACT'}], 'facility': 'General Hospital', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'zip': '59225', 'city': 'Denain', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Pierre GRIGNET, MD', 'role': 'CONTACT'}], 'facility': 'General Hospital', 'geoPoint': {'lat': 50.3293, 'lon': 3.3943}}, {'zip': '26220', 'city': 'Dieulefit', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric HERENGT, MD', 'role': 'CONTACT'}], 'facility': 'Dieulefit Santé Clinic', 'geoPoint': {'lat': 44.52563, 'lon': 5.0618}}, {'zip': '38130', 'city': 'Échirolles', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François ARBIB, MD', 'role': 'CONTACT'}, {'name': 'Nathalie CHOURI, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'zip': '51200', 'city': 'Épernay', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric BONGRAIN, MD', 'role': 'CONTACT'}], 'facility': 'Saint Vincent Clinic', 'geoPoint': {'lat': 49.04, 'lon': 3.95922}}, {'zip': '38000', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Janie GIREY-RANNAUD, MD', 'role': 'CONTACT'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '38000', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Louis PEPIN, Prof, PhD', 'role': 'CONTACT'}, {'name': 'Patrick LEVY, Prof, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Renaud TAMISIER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Natalia SIYANKO, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sandrine LAUNOIS, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '17000', 'city': 'La Rochelle', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric LE GUILLOU, MD', 'role': 'CONTACT'}, {'name': 'Claude GENDREAU, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '59000', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne MALLART, MD', 'role': 'CONTACT'}, {'name': 'Stéphanie FRY, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Calmette', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59800', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibaut GENTINA, MD', 'role': 'CONTACT'}, {'name': 'Jean Marc DERNIS, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Catherine LAMBLIN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marc BURE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François CODRON, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'La Louvière Clinic', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '95420', 'city': 'Magny-en-Vexin', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie NARES, MD', 'role': 'CONTACT'}], 'facility': 'General Hospital', 'geoPoint': {'lat': 49.15515, 'lon': 1.78669}}, {'zip': '13000', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hervé PEGLIASCO, MD', 'role': 'CONTACT'}], 'facility': 'Ambroise Paré Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '26216', 'city': 'Montélimar', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique MARTINEAU, MD', 'role': 'CONTACT'}, {'name': 'Gilbert SALARD, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'General Hospital', 'geoPoint': {'lat': 44.55468, 'lon': 4.75469}}, {'zip': '57950', 'city': 'Montigny-lès-Metz', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique MULLER, MD', 'role': 'CONTACT'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 49.0956, 'lon': 6.15271}}, {'zip': '30900', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier BENEZET, MD', 'role': 'CONTACT'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '26110', 'city': 'Nyons', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gabrielle VOTTERO, MD', 'role': 'CONTACT'}, {'name': 'Jorge Lucilo BENGOLEA, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Valérie MAYER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bernard PORSIN, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Les Rieux Clinic', 'geoPoint': {'lat': 44.36082, 'lon': 5.14052}}, {'zip': '75018', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': "Marie-Pia D'ORTHO, Prof, PhD", 'role': 'CONTACT'}], 'facility': 'Hospital Bichat Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51000', 'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric MASURE, MD', 'role': 'CONTACT'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-François MUIR, Prof, PhD', 'role': 'CONTACT'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '57500', 'city': 'Saint-Avold', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christian KOLTES, MD', 'role': 'CONTACT'}], 'facility': 'General Hospital', 'geoPoint': {'lat': 49.10465, 'lon': 6.70402}}, {'zip': '42100', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique MOUNIER, MD', 'role': 'CONTACT'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '38330', 'city': 'Saint-Ismier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique BERTRAND, MD', 'role': 'CONTACT'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 45.25227, 'lon': 5.83073}}, {'zip': '06700', 'city': 'Saint-Laurent-du-Var', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guy BOYER, MD', 'role': 'CONTACT'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 43.67323, 'lon': 7.19}}, {'zip': '62500', 'city': 'Saint-Omer', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe RICHARD, MD', 'role': 'CONTACT'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 50.74834, 'lon': 2.26091}}, {'zip': '83140', 'city': 'Six-Fours-les-Plages', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mireille PADOVANI, MD', 'role': 'CONTACT'}, {'name': 'Gaël CHAIGNEAU, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 43.09174, 'lon': 5.82465}}, {'zip': '83000', 'city': 'Toulon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu LARROUSSE, MD', 'role': 'CONTACT'}, {'name': 'Catherine PACCHIONI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philippe SALLETTAZ, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '26000', 'city': 'Valence', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yves GRILLET, MD', 'role': 'CONTACT'}, {'name': 'Florence BOIS, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Respiratory physician in private practice', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'zip': '59300', 'city': 'Valenciennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bruno STACH, MD', 'role': 'CONTACT'}], 'facility': 'Tessier Clinic', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '69655', 'city': 'Villefranche-sur-Saône', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lionel FALCHERO, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Nord Ouest', 'geoPoint': {'lat': 45.98967, 'lon': 4.71961}}], 'centralContacts': [{'name': 'Jean Louis PEPIN, Prof, PhD', 'role': 'CONTACT', 'email': 'JPepin@chu-grenoble.fr', 'phone': '0033476765516'}], 'overallOfficials': [{'name': 'Jean Louis PEPIN, Prof, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fédération Française de Pneumologie', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federation of Medical Specialties', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, PhD, Hospital Grenoble France', 'investigatorFullName': 'Jean Louis PEPIN', 'investigatorAffiliation': 'Fédération Française de Pneumologie'}}}}