NCT04963192

Brief 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 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 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 10, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

3.3 years

First QC Date

June 21, 2021

Last Update Submit

January 2, 2024

Conditions

Sleep Apnea, ObstructiveChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (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

    at inclusion and at 6 months

Secondary Outcomes (15)

  • Change of Physical activity (average daily steps) for OSA patient only

    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

    One week before initiation of NIV treatment and at Month 3 and Month 6

  • Change of Physical activity assessed by the IPAQ questionnaire

    At the inclusion, Month 3 and Month 6

  • Change of Weight measured by a connected scale

    Before CPAP or NIV treatment, at Month 3 and Month 6

  • Change of Arterial pressure measured by a connected tensiometer

    Before CPAP or NIV treatment, at Month 3 and Month 6

  • +10 more secondary outcomes

Study Arms (1)

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

Device: Connected actimeter to measure physical activity in OSA patientsDevice: Connected BORA Band to measure physical activity in COPD patients onlyOther: IPAQ to evaluated physical activityDevice: Connected scale to measure weightDevice: Connected tensiometer to measure arterial pressureDevice: Connected BORA Band to measure oxygen saturation in COPD patients onlyDevice: Connected BORA Band to measure heart rate in COPD patients onlyDevice: Connected BORA Band to measure respiratory rate in COPD patients onlyOther: EXASCORE to evaluated COPD severityOther: Epworth scale to evaluate sleepinessOther: Pichot scale to evaluate fatigueOther: Usability questionnaireOther: SF36 questionnaire

Interventions

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

OSA or COPD patients having an integrated management at home
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

OSA or COPD patients having an integrated management at home
IPAQ to evaluated physical activityOTHER

Physical activity evaluated by IPAQ (International Physical Activity Questionnaire) at the inclusion, M3 and M6

OSA or COPD patients having an integrated management at home
Connected scale to measure weightDEVICE

Weight measured by a connected scale, before CPAP or NIV treatment, at M3 and M6

OSA or COPD patients having an integrated management at home
Connected tensiometer to measure arterial pressureDEVICE

Arterial pressure measured by a connected tensiometer, before CPAP or NIV treatment, at M3 and M6

OSA or COPD patients having an integrated management at home
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

OSA or COPD patients having an integrated management at home
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

OSA or COPD patients having an integrated management at home
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

OSA or COPD patients having an integrated management at home
EXASCORE to evaluated COPD severityOTHER

COPD severity evaluated by the EXASCORE questionnaire at inclusion, M3 and M6 for COPD patients only

OSA or COPD patients having an integrated management at home
Epworth scale to evaluate sleepinessOTHER

Sleepiness evaluated by the Epworth scale at baseline, M3 and M6

OSA or COPD patients having an integrated management at home
Pichot scale to evaluate fatigueOTHER

Fatigue evaluated by the Pichot scale at inclusion, M3 and M6

OSA or COPD patients having an integrated management at home
Usability questionnaireOTHER

Subjective assessment of each device by means of usability questionnaire at M6

OSA or COPD patients having an integrated management at home
SF36 questionnaireOTHER

Quality of life evaluated by the SF36 questionnaire at inclusion and M6

OSA or COPD patients having an integrated management at home

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grenoble Alpes University Hospital

Grenoble, 38000, France

ENROLLING BY INVITATION

Verdun Hospital

Verdun, 55100, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40986800DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructivePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Louis PEPIN, MD, PhD

    Grenoble Alpes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie JOYEUX-FAURE, PharmD, PhD

CONTACT

334 767 692 65mjoyeuxfaure@chu-grenoble.fr

Robin TERRAIL, MBA

CONTACT

334 767 671 66rterrail@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2021

First Posted

July 15, 2021

Study Start

September 10, 2021

Primary Completion

December 31, 2024

Study Completion

February 28, 2025

Last Updated

January 3, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)