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

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Other: CPAP associated with connected devices: blood pressure monitor , scales and activity monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04054180

38RC18.338

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obstructive sleep apnea syndrome not treated with CPAP and defined by an apnea-hypopnea index (AHI) greater than 15 events per hour and with more than 80% of obstructive events, determined by polysomnography (PSG) or polygraphy (PG) within the last 6 months
• Treated hypertension or newly diagnosed hypertension defined as 140 ≤ SBP <180 mmHg and 90 ≤ DBP<110 mmHg
• BMI > 28 kg / m²
• Smartphone
• Able to use a mobile application on a personal smartphone
• Medical certificate for the practice of physical activity/exercise
• Patients who have freely given their informed written consent
• Person affiliated to the French social security system

Exclusion criteria

• Central sleep apnea syndrome
• Patient with planned bariatric surgery
• Severe bullous emphysema
• Pneumothorax
• Trauma or recent surgery to or affecting the forebrain with sequelae of cranio-naso/pharyngeal fistula
• Decompensated cardiac insufficiency or hypotension, particularly in the event of reduced blood volume or in the case of cardiac arrhythmias
• Dehydration
• Tracheotomy
• Pregnant or lactating women
• Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research project that may impact the study
• Patients under guardianship or curatorship
• Patients not affiliated to the French social security system or equivalent
• Patients deprived of their liberty or hospitalized without their consent
• Major patients protected by law
• Person under administrative or judicial review
• Minor patients

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

CPAP S.Box associated with its 3 connected devices

Experimental group

Description:

S.BOXTM CPAP associated with its 3 connected devices Each patient will be monitored by a CPAP S.Box, with a Sefam Access application installed on their Smartphone to collect data from 3 connected measuring devices: PROMs, an activity monitor and a blood pressure monitor.

Treatment:

Other: CPAP associated with connected devices: blood pressure monitor , scales and activity monitor