NCT04054180

Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): (SLEEPCONNECT)

Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): a Prospective Intervention (SLEEPCONNECT)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Continuous positive airway pressure (CPAP) is the first line therapy for Obstructive Sleep Apnea Syndrome (OSAS) but has limited impact for reducing cardio-metabolic risk. Combined treatment strategies including physical activity and weight loss management have emerged in association with CPAP. Patient's engagement might be supported by connected devices and smartphone applications measuring physical activity, blood pressure, weight and sleep duration. Data fusion of these parameters with CPAP-remote telemonitoring will allow personalized coaching and integrated care of OSAS with cardio-metabolic co-morbidities.

Detailed description

"SLEEPCONNECT" is a prospective multicenter observational study with: * Evaluation of the impact of multimodal remote monitoring using connected devices and a dedicated smartphone application on the control of blood pressure after 3 months of CPAP. * Evaluation of impact of such an integrated care on physical activity and body weight This study is supported by the S.BOXTM CPAP device and its companion connected devices (physical activity, blood pressure, sleep duration, weight) and smartphone application collecting CPAP telemonitoring and assessing patients reported outcomes (PROMs). Patients have a continuous access to their own data. Digital health system will be complemented by physical activity and nutrition coaching. Coaching persons will be inform during the follow-up by data collected by connected devices and app.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
OTHER	CPAP associated with connected devices: blood pressure monitor , scales and activity monitor	CPAP associated with connected devices: blood pressure monitor , PROMs and activity monitor Patients will use their connected devices for one year. Data from the connected devices will be transmitted to their smartphone application Sefam Access. At the beginning of the study, patients will have a dietary assessment and start a support program for nutrition counselling and physical activity. At each study visit the dietician and physical exercise coach will give the patient advices on diet and for adjusting physical activity.

Timeline

• Start date: 2021-06-07
• Primary completion: 2024-01-30
• Completion: 2024-02-28
• First posted: 2019-08-13
• Last updated: 2024-03-06

Locations

1 site across 1 country: France