Integrated Management of Chronic Respiratory Diseases

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

September 10, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

February 28, 2025

Conditions
Sleep Apnea, ObstructiveChronic Obstructive Pulmonary Disease
Interventions
DEVICE

Connected actimeter to measure physical activity in OSA patients

Connected actimeter worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for OSA patients

DEVICE

Connected BORA Band to measure physical activity in COPD patients only

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

OTHER

IPAQ to evaluated physical activity

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

DEVICE

Connected scale to measure weight

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

DEVICE

Connected tensiometer to measure arterial pressure

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

DEVICE

Connected BORA Band to measure oxygen saturation in COPD patients only

Daily oxygen saturation measured by the connected BORA Band for COPD patients only during 6 months

DEVICE

Connected BORA Band to measure heart rate in COPD patients only

Daily heart rate measured by the connected BORA Band for COPD patients only during 6 months

DEVICE

Connected BORA Band to measure respiratory rate in COPD patients only

Daily respiratory rate measured by the connected BORA Band for COPD patients only during 6 months

OTHER

EXASCORE to evaluated COPD severity

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

OTHER

Epworth scale to evaluate sleepiness

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

OTHER

Pichot scale to evaluate fatigue

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

OTHER

Usability questionnaire

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

OTHER

SF36 questionnaire

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

Trial Locations (2)

38000

ENROLLING_BY_INVITATION

Grenoble Alpes University Hospital, Grenoble

55100

RECRUITING

Verdun Hospital, Verdun

All Listed Sponsors
collaborator

EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital

UNKNOWN

collaborator

Pneumology Department, Verdun Hospital

UNKNOWN

collaborator

BIOSENCY compagny

UNKNOWN

collaborator

SEFAM compagnie

UNKNOWN

collaborator

ADOR - Territorial Support Network, Device and Tools for Primary Care Teams

UNKNOWN

collaborator

PULSY - Regional Support Group for the Development of e-health

UNKNOWN

collaborator

eMeuse-Santé consortium

UNKNOWN

lead

University Hospital, Grenoble

OTHER

NCT04963192 - Integrated Management of Chronic Respiratory Diseases | Biotech Hunter | Biotech Hunter