AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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.

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

France2 sites, 2 recruiting

  • Grenoble Alpes University Hospital

    Grenoble, 38000

    Enrolling by invitation

  • Verdun Hospital

    Verdun, 55100

    Murielle PARENT, mparent1@ch-verdun.fr

    Céline CARDOSO-PARMENTIER, nurse, ccardoso@ch-verdun.fr

    Recruiting

Other trials in France

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:
  1. Treatment compliance (CPAP or NIV/oxygen therapy)
  2. Physical activity
  3. Weight
  4. Mean arterial pressure
  5. Oxygen saturation, heart rate and respiratory rate for COPD patients
  6. Severity of COPD for the patients concerned
  7. Daytime sleepiness
  8. Fatigue
  9. 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:
  1. Treatment compliance (CPAP or NIV/oxygen therapy)
  2. Physical activity, measured by an actimeter for OSAS patients or by the BORA Band device for COPD patients, for one week and IPAQ
  3. Weight, measured by a connected scale
  4. Average blood pressure, measured by a connected blood pressure monitor
  5. Oxygen saturation, heart rate and respiratory rate measured by the BORA Band for COPD patients
  6. The severity of COPD by the EXASCORE questionnaire for the patients concerned
  7. Daytime sleepiness by the Epworth questionnaire
  8. Fatigue by the Pichot scale
  9. 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 groups in NCT04963192
Study groupRoleWhat they receive
OSA or COPD patients having an integrated management at homeExperimentalOSA 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  1. First posted15 Jul 2021
  2. Study start10 Sep 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion28 Feb 2025 (estimated)

Resources

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)
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

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in