Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 38RC21.149 | Other Identifier | Grenoble Alpes University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital | UNKNOWN |
| Pneumology Department, Verdun Hospital | UNKNOWN |
| BIOSENCY compagny | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
This 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.
The 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.
The secondary objectives:
To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:
To analyze the trajectories of the measures collected throughout the integrated management to identify specific profiles.
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).
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.
This 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.
The 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.
The secondary objectives:
To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:
To analyze the trajectories of the measures collected throughout the integrated management to identify specific profiles.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA or COPD patients having an integrated management at home | Experimental | OSA or COPD patients having an integrated management at home using connected devices, during 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connected actimeter to measure physical activity in OSA patients | Device | Connected actimeter worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for OSA patients |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Quality of life assessed by the SF36 questionnaire | Change of quality of life, assessed by the SF36 questionnaire, from Baseline (at inclusion) and after 6 months of an integrated management at home | at inclusion and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Physical activity (average daily steps) for OSA patient only | 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 | One week before initiation of CPAP treatment and at Month 3 and Month 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie JOYEUX-FAURE, PharmD, PhD | Contact | 334 767 692 65 | mjoyeuxfaure@chu-grenoble.fr | |
| Robin TERRAIL, MBA | Contact | 334 767 671 66 | rterrail@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis PEPIN, MD, PhD | Grenoble Alpes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble Alpes University Hospital | Enrolling by invitation | Grenoble | 38000 | France | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40986800 | Derived | 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 Clinical Trials. Ann Am Thorac Soc. 2026 Jan 1;23(1):117-124. doi: 10.1513/AnnalsATS.202505-504OC. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SEFAM compagnie |
| UNKNOWN |
| ADOR - Territorial Support Network, Device and Tools for Primary Care Teams | UNKNOWN |
| PULSY - Regional Support Group for the Development of e-health | UNKNOWN |
| eMeuse-Santé consortium | UNKNOWN |
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
Not provided
Not provided
Not provided
Not provided
| Connected BORA Band to measure physical activity in COPD patients only | Device | 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 |
|
| IPAQ to evaluated physical activity | Other | Physical activity evaluated by IPAQ (International Physical Activity Questionnaire) at the inclusion, M3 and M6 |
|
| Connected scale to measure weight | Device | Weight measured by a connected scale, before CPAP or NIV treatment, at M3 and M6 |
|
| Connected tensiometer to measure arterial pressure | Device | Arterial pressure measured by a connected tensiometer, before CPAP or NIV treatment, at M3 and M6 |
|
| Connected BORA Band to measure oxygen saturation in COPD patients only | Device | Daily oxygen saturation measured by the connected BORA Band for COPD patients only during 6 months |
|
| Connected BORA Band to measure heart rate in COPD patients only | Device | Daily heart rate measured by the connected BORA Band for COPD patients only during 6 months |
|
| Connected BORA Band to measure respiratory rate in COPD patients only | Device | Daily respiratory rate measured by the connected BORA Band for COPD patients only during 6 months |
|
| EXASCORE to evaluated COPD severity | Other | COPD severity evaluated by the EXASCORE questionnaire at inclusion, M3 and M6 for COPD patients only |
|
| Epworth scale to evaluate sleepiness | Other | Sleepiness evaluated by the Epworth scale at baseline, M3 and M6 |
|
| Pichot scale to evaluate fatigue | Other | Fatigue evaluated by the Pichot scale at inclusion, M3 and M6 |
|
| Usability questionnaire | Other | Subjective assessment of each device by means of usability questionnaire at M6 |
|
| SF36 questionnaire | Other | Quality of life evaluated by the SF36 questionnaire at inclusion and M6 |
|
| Change of Physical activity (average daily steps) for COPD patient only |
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 |
| One week before initiation of NIV treatment and at Month 3 and Month 6 |
| Change of Physical activity assessed by the IPAQ questionnaire | 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 | At the inclusion, Month 3 and Month 6 |
| Change of Weight measured by a connected scale | 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. | Before CPAP or NIV treatment, at Month 3 and Month 6 |
| Change of Arterial pressure measured by a connected tensiometer | 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. | Before CPAP or NIV treatment, at Month 3 and Month 6 |
| Daily oxygen saturation measured by the connected BORA Band for COPD patients only | Daily oxygen saturation measured by the connected BORA Band for COPD patients only | During 6 months |
| Daily heart rate measured by the connected BORA Band for COPD patients only | Daily heart rate measured by the connected BORA Band for COPD patients only | During 6 months |
| Daily respiratory rate measured by the connected BORA Band for COPD patients only | Daily respiratory rate measured by the connected BORA Band for COPD patients only | During 6 months |
| Change of COPD severity evaluated by the EXASCORE questionnaire for COPD patients only | 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. | At the inclusion, Month 3 and Month 6 |
| Change of Sleepiness evaluated by the Epworth questionnaire | Change of Sleepiness evaluated by the Epworth questionnaire, from Baseline (at inclusion), and after 3 and 6 months of an integrated management at home. | At baseline, Month 3 and Month 6 |
| Change of Fatigue evaluated by the Pichot questionnaire | Change of Fatigue evaluated by the Pichot questionnaire, from Baseline (at inclusion), and after 3 and 6 months of an integrated management at home. | At inclusion, Month 3 and Month 6 |
| Satisfaction and usage of the connected scale assessed by a specific questionnaire | Satisfaction and usage of the connected scale assessed by a specific questionnaire, after 6 months of an integrated management at home | At Month 6 |
| Satisfaction and usage of the connected tensiometer assessed by a specific questionnaire | Satisfaction and usage of the connected tensiometer assessed by a specific questionnaire, after 6 months of an integrated management at home | At Month 6 |
| Satisfaction and usage of the connected actimeter assessed by a specific questionnaire, for OSA patients only | 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 | At Month 6 |
| Satisfaction and usage of the connected BORA Band assessed by a specific questionnaire, for COPD patients only | 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 | At Month 6 |
| Verdun Hospital |
| Recruiting |
| Verdun |
| 55100 |
| France |
|
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided