An interventional study of Connected actimeter to measure physical activity in OSA patients and Connected BORA Band to measure physical activity in COPD patients only in Sleep Apnea, Obstructive and Chronic Obstructive Pulmonary Disease, sponsored by University Hospital, Grenoble. Recruiting at 2 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Supportive care
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:
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:
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's planned enrollment of 400 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
OSA or COPD patients having an integrated management at home using connected devices, during 6 months
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
Connected actimeter worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for OSA patients
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
Physical activity evaluated by IPAQ (International Physical Activity Questionnaire) at the inclusion, M3 and M6
Weight measured by a connected scale, before CPAP or NIV treatment, at M3 and M6
Arterial pressure measured by a connected tensiometer, before CPAP or NIV treatment, at M3 and M6
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 during 6 months
Daily respiratory rate measured by the connected BORA Band for COPD patients only during 6 months
COPD severity evaluated by the EXASCORE questionnaire at inclusion, M3 and M6 for COPD patients only
Sleepiness evaluated by the Epworth scale at baseline, M3 and M6
Fatigue evaluated by the Pichot scale at inclusion, M3 and M6
Subjective assessment of each device by means of usability questionnaire at M6
Quality of life evaluated by the SF36 questionnaire at inclusion and M6
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
Time frame: at inclusion and at 6 months
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
Time frame: One week before initiation of CPAP treatment and at Month 3 and Month 6
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At Month 6
Plan to share: No
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University Hospital, Grenoble