Sleep Apnea, ObstructiveeMEUSE-SANTENCT04963192
Integrated Management of Chronic Respiratory Diseases
A study testing Connected actimeter to measure physical activity in OSA patients, Connected BORA Band to measure physical activity in COPD patients only and IPAQ to evaluated physical activity in people with Sleep Apnea, Obstructive and Chronic Obstructive Pulmonary Disease, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Connected actimeter to measure physical activity in OSA patients, Connected BORA Band to measure physical activity in COPD patients only and IPAQ to evaluated physical activity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Sep 2021to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a chronic respiratory pathology such as:
- Newly diagnosed OSA with indication for CPAP treatment
- And/or COPD with or without indication for NIV/oxygen therapy
- Have a smartphone (with Android or iOS) allowing the installation of applications for connected objects
- Be able to use a mobile application on a personal smartphone
- Person agreeing to the telemonitoring of CPAP or NIV/oxygen therapy compliance data by the healthcare provider
- Patient who has provided consent to participate in the study
- Person affiliated to the social security
Who cannot join
- Pregnant or breastfeeding woman
- Patient unable to give consent to participate in the study
- Patient under guardianship or curatorship
- Patient not affiliated to the social security system
- Patient deprived of liberty or hospitalized
- Patient protected by law
- Patient under administrative or judicial control
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Enrolling by invitation
Grenoble Alpes University Hospital
Grenoble, 38000
- Recruiting
Verdun Hospital
Verdun, 55100
Murielle PARENT, mparent1@ch-verdun.fr
Céline CARDOSO-PARMENTIER, nurse, ccardoso@ch-verdun.fr
About this study
Official title: Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE
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.
Read more
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:
- Treatment compliance (CPAP or NIV/oxygen therapy)
- Physical activity
- Weight
- Mean arterial pressure
- Oxygen saturation, heart rate and respiratory rate for COPD patients
- Severity of COPD for the patients concerned
- Daytime sleepiness
- Fatigue
- Patient acceptability of the use of connected objects
- 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).
Read the detailed description
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:
- Treatment compliance (CPAP or NIV/oxygen therapy)
- Physical activity, measured by an actimeter for OSAS patients or by the BORA Band device for COPD patients, for one week and IPAQ
- Weight, measured by a connected scale
- Average blood pressure, measured by a connected blood pressure monitor
- Oxygen saturation, heart rate and respiratory rate measured by the BORA Band for COPD patients
- The severity of COPD by the EXASCORE questionnaire for the patients concerned
- Daytime sleepiness by the Epworth questionnaire
- Fatigue by the Pichot scale
- Patients' acceptability of the use of the connected objects by questionnaires of satisfaction of use at 6 months.
- 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).
- Being tested
- Connected actimeter to measure physical activity in OSA patients, Connected BORA Band to measure physical activity in COPD patients only, IPAQ to evaluated physical activity, Connected scale to measure weight, Connected tensiometer to measure arterial pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected actimeter to measure physical activity in OSA patientsDevice
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 to measure physical activity in COPD patients onlyDevice
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 activityOther
Physical activity evaluated by IPAQ (International Physical Activity Questionnaire) at the inclusion, M3 and M6
Connected scale to measure weightDevice
Weight measured by a connected scale, before CPAP or NIV treatment, at M3 and M6
Connected tensiometer to measure arterial pressureDevice
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 onlyDevice
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 onlyDevice
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 onlyDevice
Daily respiratory rate measured by the connected BORA Band for COPD patients only during 6 months
EXASCORE to evaluated COPD severityOther
COPD severity evaluated by the EXASCORE questionnaire at inclusion, M3 and M6 for COPD patients only
Epworth scale to evaluate sleepinessOther
Sleepiness evaluated by the Epworth scale at baseline, M3 and M6
Pichot scale to evaluate fatigueOther
Fatigue evaluated by the Pichot scale at inclusion, M3 and M6
Usability questionnaireOther
Subjective assessment of each device by means of usability questionnaire at M6
SF36 questionnaireOther
Quality of life evaluated by the SF36 questionnaire at inclusion and M6
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at inclusion and at 6 months
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start10 Sep 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital, Pneumology Department, Verdun Hospital, BIOSENCY compagny, SEFAM compagnie, ADOR - Territorial Support Network, Device and Tools for Primary Care Teams, PULSY - Regional Support Group for the Development of e-health, eMeuse-Santé consortium
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, MD, PhD, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963192
- Sponsor's protocol ID
- 2021-A01126-35
- Other IDs
- 38RC21.149
- Acronym
- eMEUSE-SANTE
- Status last verified
- Jan 2024
- First submitted
- 21 Jun 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40986800
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE
- ClinicalTrials.gov ID
- NCT04963192
- Acronym / sponsor ID
- eMEUSE-SANTE / 2021-A01126-35
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital, Pneumology Department, Verdun Hospital, BIOSENCY compagny, SEFAM compagnie, ADOR - Territorial Support Network, Device and Tools for Primary Care Teams, PULSY - Regional Support Group for the Development of e-health, eMeuse-Santé consortium
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Treatment compliance (CPAP or NIV/oxygen therapy)
- Physical activity
- Weight
- Mean arterial pressure
- Oxygen saturation, heart rate and respiratory rate for COPD patients
- Severity of COPD for the patients concerned
- Daytime sleepiness
- Fatigue
- Patient acceptability of the use of connected objects
- 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).
Detailed description
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:
- Treatment compliance (CPAP or NIV/oxygen therapy)
- Physical activity, measured by an actimeter for OSAS patients or by the BORA Band device for COPD patients, for one week and IPAQ
- Weight, measured by a connected scale
- Average blood pressure, measured by a connected blood pressure monitor
- Oxygen saturation, heart rate and respiratory rate measured by the BORA Band for COPD patients
- The severity of COPD by the EXASCORE questionnaire for the patients concerned
- Daytime sleepiness by the Epworth questionnaire
- Fatigue by the Pichot scale
- Patients' acceptability of the use of the connected objects by questionnaires of satisfaction of use at 6 months.
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| OSA or COPD patients having an integrated management at home | Experimental | 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 questionnaireOSA or COPD patients having an integrated management at home using connected devices, during 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with a chronic respiratory pathology such as:
- Newly diagnosed OSA with indication for CPAP treatment
- And/or COPD with or without indication for NIV/oxygen therapy
- Have a smartphone (with Android or iOS) allowing the installation of applications for connected objects
- Be able to use a mobile application on a personal smartphone
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding woman
- Patient unable to give consent to participate in the study
- Patient under guardianship or curatorship
- Patient not affiliated to the social security system
- Patient deprived of liberty or hospitalized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connected actimeter to measure physical activity in OSA patientsConnected actimeter worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for OSA patients | Device | OSA or COPD patients having an integrated management at home |
| Connected BORA Band to measure physical activity in COPD patients onlyConnected BORA Band worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for COPD patients only | Device | OSA or COPD patients having an integrated management at home |
| IPAQ to evaluated physical activityPhysical activity evaluated by IPAQ (International Physical Activity Questionnaire) at the inclusion, M3 and M6 | Other | OSA or COPD patients having an integrated management at home |
| Connected scale to measure weightWeight measured by a connected scale, before CPAP or NIV treatment, at M3 and M6 | Device | OSA or COPD patients having an integrated management at home |
| Connected tensiometer to measure arterial pressureArterial pressure measured by a connected tensiometer, before CPAP or NIV treatment, at M3 and M6 | Device | OSA or COPD patients having an integrated management at home |
| Connected BORA Band to measure oxygen saturation in COPD patients onlyDaily oxygen saturation measured by the connected BORA Band for COPD patients only during 6 months | Device | OSA or COPD patients having an integrated management at home |
| Connected BORA Band to measure heart rate in COPD patients onlyDaily heart rate measured by the connected BORA Band for COPD patients only during 6 months | Device | OSA or COPD patients having an integrated management at home |
| Connected BORA Band to measure respiratory rate in COPD patients onlyDaily respiratory rate measured by the connected BORA Band for COPD patients only during 6 months | Device | OSA or COPD patients having an integrated management at home |
| EXASCORE to evaluated COPD severityCOPD severity evaluated by the EXASCORE questionnaire at inclusion, M3 and M6 for COPD patients only | Other | OSA or COPD patients having an integrated management at home |
| Epworth scale to evaluate sleepinessSleepiness evaluated by the Epworth scale at baseline, M3 and M6 | Other | OSA or COPD patients having an integrated management at home |
| Pichot scale to evaluate fatigueFatigue evaluated by the Pichot scale at inclusion, M3 and M6 | Other | OSA or COPD patients having an integrated management at home |
| Usability questionnaireSubjective assessment of each device by means of usability questionnaire at M6 | Other | OSA or COPD patients having an integrated management at home |
| SF36 questionnaireQuality of life evaluated by the SF36 questionnaire at inclusion and M6 | Other | OSA or COPD patients having an integrated management at home |
Primary outcome
Change of Quality of life assessed by the SF36 questionnaire
Time frame: at inclusion and at 6 months
Change of quality of life, assessed by the SF36 questionnaire, from Baseline (at inclusion) and after 6 months of an integrated management at home
15 secondary outcomes
Change of Physical activity (average daily steps) for OSA patient only
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
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
Time frame: At the inclusion, Month 3 and Month 6
Change of Weight measured by a connected scale
Time frame: Before CPAP or NIV treatment, at Month 3 and Month 6
Change of Arterial pressure measured by a connected tensiometer
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
Time frame: During 6 months
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
Time frame: During 6 months
Change of COPD severity evaluated by the EXASCORE questionnaire for COPD patients only
Time frame: At the inclusion, Month 3 and Month 6
Change of Sleepiness evaluated by the Epworth questionnaire
Time frame: At baseline, Month 3 and Month 6
Change of Fatigue evaluated by the Pichot questionnaire
Time frame: At inclusion, Month 3 and Month 6
Satisfaction and usage of the connected scale assessed by a specific questionnaire
Time frame: At Month 6
Satisfaction and usage of the connected tensiometer assessed by a specific questionnaire
Time frame: At Month 6
Satisfaction and usage of the connected actimeter assessed by a specific questionnaire, for OSA patients only
Time frame: At Month 6
Satisfaction and usage of the connected BORA Band assessed by a specific questionnaire, for COPD patients only
Time frame: At Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 40986800Coiffier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis PEPIN, MD, PhD principal investigator
Grenoble Alpes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected actimeter to measure physical activity in OSA patients, Connected BORA Band to measure physical activity in COPD patients only and IPAQ to evaluated physical activity in people with Sleep Apnea, Obstructive and Chronic Obstructive Pulmonary Disease, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie JOYEUX-FAURE, PharmD, PhD (334 767 692 65, mjoyeuxfaure@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Quality of life assessed by the SF36 questionnaire (time frame: at inclusion and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04963192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.