Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-26 @ 4:44 AM
Study NCT ID:
NCT04963192
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Management of Chronic Respiratory Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic 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'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A prospective clinical study, conducted at the Verdun Hospital, in patients with a chronic respiratory pathology (OSA or COPD), including an integrated management at home using connected devices, during 6 months'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-02', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Quality of life assessed by the SF36 questionnaire', 'timeFrame': 'at inclusion and at 6 months', 'description': 'Change of quality of life, assessed by the SF36 questionnaire, from Baseline (at inclusion) and after 6 months of an integrated management at home'}], 'secondaryOutcomes': [{'measure': 'Change of Physical activity (average daily steps) for OSA patient only', 'timeFrame': 'One week before initiation of CPAP treatment and at Month 3 and Month 6', 'description': 'Change of the physical activity using a connected actimeter for OSA patients only, from Baseline (one week before treatment) and after 3 and 6 months of an integrated management at home'}, {'measure': 'Change of Physical activity (average daily steps) for COPD patient only', 'timeFrame': 'One week before initiation of NIV treatment and at Month 3 and Month 6', 'description': 'Change of the physical activity using the connected BORA Band for COPD patients only, from Baseline (one week before treatment) and after 3 and 6 months of an integrated management at home'}, {'measure': 'Change of Physical activity assessed by the IPAQ questionnaire', 'timeFrame': 'At the inclusion, Month 3 and Month 6', 'description': 'Change of Physical activity assessed by the IPAQ (International Physical Activity Questionnaire), from Baseline (at inclusion) and after 3 and 6 months of an integrated management at home'}, {'measure': 'Change of Weight measured by a connected scale', 'timeFrame': 'Before CPAP or NIV treatment, at Month 3 and Month 6', 'description': 'Change of Weight measured by a connected scale, from Baseline (before CPAP or NIV treatment), and after 3 and 6 months of an integrated management at home.'}, {'measure': 'Change of Arterial pressure measured by a connected tensiometer', 'timeFrame': 'Before CPAP or NIV treatment, at Month 3 and Month 6', 'description': 'Change of Arterial pressure measured by a connected tensiometer, from Baseline (before CPAP or NIV treatment), and after 3 and 6 months of an integrated management at home.'}, {'measure': 'Daily oxygen saturation measured by the connected BORA Band for COPD patients only', 'timeFrame': 'During 6 months', 'description': 'Daily oxygen saturation measured by the connected BORA Band for COPD patients only'}, {'measure': 'Daily heart rate measured by the connected BORA Band for COPD patients only', 'timeFrame': 'During 6 months', 'description': 'Daily heart rate measured by the connected BORA Band for COPD patients only'}, {'measure': 'Daily respiratory rate measured by the connected BORA Band for COPD patients only', 'timeFrame': 'During 6 months', 'description': 'Daily respiratory rate measured by the connected BORA Band for COPD patients only'}, {'measure': 'Change of COPD severity evaluated by the EXASCORE questionnaire for COPD patients only', 'timeFrame': 'At the inclusion, Month 3 and Month 6', 'description': 'Change of COPD severity evaluated by the EXASCORE questionnaire for COPD patients only, from Baseline (at inclusion), and after 3 and 6 months of an integrated management at home.'}, {'measure': 'Change of Sleepiness evaluated by the Epworth questionnaire', 'timeFrame': 'At baseline, Month 3 and Month 6', 'description': 'Change of Sleepiness evaluated by the Epworth questionnaire, from Baseline (at inclusion), and after 3 and 6 months of an integrated management at home.'}, {'measure': 'Change of Fatigue evaluated by the Pichot questionnaire', 'timeFrame': 'At inclusion, Month 3 and Month 6', 'description': 'Change of Fatigue evaluated by the Pichot questionnaire, from Baseline (at inclusion), and after 3 and 6 months of an integrated management at home.'}, {'measure': 'Satisfaction and usage of the connected scale assessed by a specific questionnaire', 'timeFrame': 'At Month 6', 'description': 'Satisfaction and usage of the connected scale assessed by a specific questionnaire, after 6 months of an integrated management at home'}, {'measure': 'Satisfaction and usage of the connected tensiometer assessed by a specific questionnaire', 'timeFrame': 'At Month 6', 'description': 'Satisfaction and usage of the connected tensiometer assessed by a specific questionnaire, after 6 months of an integrated management at home'}, {'measure': 'Satisfaction and usage of the connected actimeter assessed by a specific questionnaire, for OSA patients only', 'timeFrame': 'At Month 6', 'description': 'Satisfaction and usage of the connected actimeter assessed by a specific questionnaire, for OSA patients only, after 6 months of an integrated management at home'}, {'measure': 'Satisfaction and usage of the connected BORA Band assessed by a specific questionnaire, for COPD patients only', 'timeFrame': 'At Month 6', 'description': 'Satisfaction and usage of the connected BORA Band assessed by a specific questionnaire, for COPD patients only, after 6 months of an integrated management at home'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea, Obstructive', 'Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '40986800', 'type': 'DERIVED', 'citation': 'Coiffier O, Bailly S, Joyeux-Faure M, Tamisier R, Amrani K, Cornu JC, Gentina T, Terrail R, Causse C, Lombardi C, Pengo MF, Parati G, Pepin JL. Home Blood Pressure Trajectories During 6 Months of Continuous Positive Airway Pressure Therapy: Results from the eMEUSE-SANTE and SLEEPCONNECT Clinic. Ann Am Thorac Soc. 2025 Sep 23. doi: 10.1513/AnnalsATS.202505-504OC. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Chronic respiratory diseases such as obstructive sleep apnea syndrome (OSA) and chronic obstructive pulmonary disease (COPD) constitute a major public health problem, due to their high prevalence, but especially because of their cardiovascular and metabolic morbidity and mortality and the associated costs for the health system. The organization of long-term management of these diseases is now part of the e-health process, digital health with the use of massive "big data" generated by care and follow-up. Therapeutic patient education and the integration of connected objects will allow personalized therapeutic education support with interventions by local medical staff adapted to the needs of the patients.\n\nThis will also allow to objectify the effect of treatments such as continuous positive airway pressure (CPAP) for OSA or non-invasive ventilation (NIV) and/or oxygen therapy for COPD, not only on the prevention of respiratory decompensation but also on cardiovascular and metabolic risk factors which are major elements of the prognosis. This project will therefore make it possible to demonstrate the feasibility and to deploy a multi-actor care pathway in the territory.\n\nThe investigators propose a prospective clinical study, conducted at the Verdun Hospital, with the main objective of studying the evolution of the quality of life of patients with a chronic respiratory pathology, during an integrated management at home for 6 months.\n\nThe secondary objectives:\n\n* To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:\n\n 1. Treatment compliance (CPAP or NIV/oxygen therapy)\n 2. Physical activity\n 3. Weight\n 4. Mean arterial pressure\n 5. Oxygen saturation, heart rate and respiratory rate for COPD patients\n 6. Severity of COPD for the patients concerned\n 7. Daytime sleepiness\n 8. Fatigue\n 9. Patient acceptability of the use of connected objects\n* To analyze the trajectories of the measures collected throughout the integrated management to identify specific profiles.\n* To analyze the daily data of the different connected objects and treatments with regard to the patients\' profiles (according to age, gender, comorbidities, OSA or COPD group).', 'detailedDescription': 'Chronic respiratory diseases such as obstructive sleep apnea syndrome (OSA) and chronic obstructive pulmonary disease (COPD) constitute a major public health problem, due to their high prevalence, but especially because of their cardiovascular and metabolic morbidity and mortality and the associated costs for the health system. There is also an inequality of access to referral care linked to demographics and territorial organization. We are currently at a turning point in the understanding of these pathologies and their coordinated management by combining therapeutic modalities. The organization of long-term management of these diseases is now part of the e-health process, digital health with the use of massive "big data" generated by care and follow-up. Therapeutic patient education and the integration of connected objects measuring weight, oxygen saturation rate, heart rate, respiratory rate, skin temperature blood pressure or physical activity will allow personalized therapeutic education support with interventions by local medical staff adapted to the needs of the patients.\n\nThis will also allow to objectify the effect of treatments such as continuous positive airway pressure (CPAP) for OSA or non-invasive ventilation (NIV) and/or oxygen therapy for COPD, not only on the prevention of respiratory decompensation but also on cardiovascular and metabolic risk factors which are major elements of the prognosis. This project will therefore make it possible to demonstrate the feasibility and to deploy a multi-actor care pathway in the territory.\n\nThe investigators propose a prospective clinical study, conducted at the Verdun Hospital, with the main objective of studying the evolution of the quality of life of patients with a chronic respiratory pathology, during an integrated management at home for 6 months.\n\nThe secondary objectives:\n\n* To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:\n\n 1. Treatment compliance (CPAP or NIV/oxygen therapy)\n 2. Physical activity, measured by an actimeter for OSAS patients or by the BORA Band device for COPD patients, for one week and IPAQ\n 3. Weight, measured by a connected scale\n 4. Average blood pressure, measured by a connected blood pressure monitor\n 5. Oxygen saturation, heart rate and respiratory rate measured by the BORA Band for COPD patients\n 6. The severity of COPD by the EXASCORE questionnaire for the patients concerned\n 7. Daytime sleepiness by the Epworth questionnaire\n 8. Fatigue by the Pichot scale\n 9. Patients\' acceptability of the use of the connected objects by questionnaires of satisfaction of use at 6 months.\n* To analyze the trajectories of the measures collected throughout the integrated management to identify specific profiles.\n* To analyze the daily data of the different connected objects and treatments with regard to the patients\' profiles (according to age, gender, comorbidities, OSA or COPD group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a chronic respiratory pathology such as:\n* Newly diagnosed OSA with indication for CPAP treatment\n* And/or COPD with or without indication for NIV/oxygen therapy\n* Have a smartphone (with Android or iOS) allowing the installation of applications for connected objects\n* Be able to use a mobile application on a personal smartphone\n* Person agreeing to the telemonitoring of CPAP or NIV/oxygen therapy compliance data by the healthcare provider\n* Patient who has provided consent to participate in the study\n* Person affiliated to the social security\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Patient unable to give consent to participate in the study\n* Patient under guardianship or curatorship\n* Patient not affiliated to the social security system\n* Patient deprived of liberty or hospitalized\n* Patient protected by law\n* Patient under administrative or judicial control\n* Patient currently participating in another clinical research study that may have an impact on the study, this impact is left to the discretion of the investigator'}, 'identificationModule': {'nctId': 'NCT04963192', 'acronym': 'eMEUSE-SANTE', 'briefTitle': 'Integrated Management of Chronic Respiratory Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE', 'orgStudyIdInfo': {'id': '2021-A01126-35'}, 'secondaryIdInfos': [{'id': '38RC21.149', 'type': 'OTHER', 'domain': 'Grenoble Alpes University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OSA or COPD patients having an integrated management at home', 'description': 'OSA or COPD patients having an integrated management at home using connected devices, during 6 months', 'interventionNames': ['Device: Connected actimeter to measure physical activity in OSA patients', 'Device: Connected BORA Band to measure physical activity in COPD patients only', 'Other: IPAQ to evaluated physical activity', 'Device: Connected scale to measure weight', 'Device: Connected tensiometer to measure arterial pressure', 'Device: Connected BORA Band to measure oxygen saturation in COPD patients only', 'Device: Connected BORA Band to measure heart rate in COPD patients only', 'Device: Connected BORA Band to measure respiratory rate in COPD patients only', 'Other: EXASCORE to evaluated COPD severity', 'Other: Epworth scale to evaluate sleepiness', 'Other: Pichot scale to evaluate fatigue', 'Other: Usability questionnaire', 'Other: SF36 questionnaire']}], 'interventions': [{'name': 'Connected actimeter to measure physical activity in OSA patients', 'type': 'DEVICE', 'description': 'Connected actimeter worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for OSA patients', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'Connected BORA Band to measure physical activity in COPD patients only', 'type': 'DEVICE', 'description': 'Connected BORA Band worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for COPD patients only', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'IPAQ to evaluated physical activity', 'type': 'OTHER', 'description': 'Physical activity evaluated by IPAQ (International Physical Activity Questionnaire) at the inclusion, M3 and M6', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'Connected scale to measure weight', 'type': 'DEVICE', 'description': 'Weight measured by a connected scale, before CPAP or NIV treatment, at M3 and M6', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'Connected tensiometer to measure arterial pressure', 'type': 'DEVICE', 'description': 'Arterial pressure measured by a connected tensiometer, before CPAP or NIV treatment, at M3 and M6', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'Connected BORA Band to measure oxygen saturation in COPD patients only', 'type': 'DEVICE', 'description': 'Daily oxygen saturation measured by the connected BORA Band for COPD patients only during 6 months', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'Connected BORA Band to measure heart rate in COPD patients only', 'type': 'DEVICE', 'description': 'Daily heart rate measured by the connected BORA Band for COPD patients only during 6 months', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'Connected BORA Band to measure respiratory rate in COPD patients only', 'type': 'DEVICE', 'description': 'Daily respiratory rate measured by the connected BORA Band for COPD patients only during 6 months', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'EXASCORE to evaluated COPD severity', 'type': 'OTHER', 'description': 'COPD severity evaluated by the EXASCORE questionnaire at inclusion, M3 and M6 for COPD patients only', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'Epworth scale to evaluate sleepiness', 'type': 'OTHER', 'description': 'Sleepiness evaluated by the Epworth scale at baseline, M3 and M6', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'Pichot scale to evaluate fatigue', 'type': 'OTHER', 'description': 'Fatigue evaluated by the Pichot scale at inclusion, M3 and M6', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'Usability questionnaire', 'type': 'OTHER', 'description': 'Subjective assessment of each device by means of usability questionnaire at M6', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}, {'name': 'SF36 questionnaire', 'type': 'OTHER', 'description': 'Quality of life evaluated by the SF36 questionnaire at inclusion and M6', 'armGroupLabels': ['OSA or COPD patients having an integrated management at home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'status': 'ENROLLING_BY_INVITATION', 'country': 'France', 'facility': 'Grenoble Alpes University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '55100', 'city': 'Verdun', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Murielle PARENT', 'role': 'CONTACT', 'email': 'mparent1@ch-verdun.fr'}, {'name': 'Céline CARDOSO-PARMENTIER, nurse', 'role': 'CONTACT', 'email': 'ccardoso@ch-verdun.fr'}, {'name': 'Jean-Claude CORNU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Khier AMRANI, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Verdun Hospital', 'geoPoint': {'lat': 49.15964, 'lon': 5.3829}}], 'centralContacts': [{'name': 'Marie JOYEUX-FAURE, PharmD, PhD', 'role': 'CONTACT', 'email': 'mjoyeuxfaure@chu-grenoble.fr', 'phone': '334 767 692 65'}, {'name': 'Robin TERRAIL, MBA', 'role': 'CONTACT', 'email': 'rterrail@chu-grenoble.fr', 'phone': '334 767 671 66'}], 'overallOfficials': [{'name': 'Jean-Louis PEPIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grenoble Alpes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital', 'class': 'UNKNOWN'}, {'name': 'Pneumology Department, Verdun Hospital', 'class': 'UNKNOWN'}, {'name': 'BIOSENCY compagny', 'class': 'UNKNOWN'}, {'name': 'SEFAM compagnie', 'class': 'UNKNOWN'}, {'name': 'ADOR - Territorial Support Network, Device and Tools for Primary Care Teams', 'class': 'UNKNOWN'}, {'name': 'PULSY - Regional Support Group for the Development of e-health', 'class': 'UNKNOWN'}, {'name': 'eMeuse-Santé consortium', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}