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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Other: CPAP associated with connected devices: blood pressure monitor , scales and activity monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, open, multicentric, national and uncontrolled study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP S.Box associated with its 3 connected devices<br>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. | Other: CPAP associated with connected devices: blood pressure monitor , scales and activity monitor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of mean value of 18 self measures blood pressure | Patients will have a connected blood pressure monitor and will make self-measurements at inclusion and 3 months after starting CPAP. Self-measurement consists of 3 measurements, with a 1 minute interval between each one, each morning and evening over 3 days. | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of variability of 18 measurements of SBP by self-measurement, between inclusion and after 3 months of CPAP treatment | Patients will have a connected blood pressure monitor and will be asked to make self-measurements at baseline and at 15 days, 1 month, 2 months, and 3 months after starting CPAP. | baseline to 3 months | 
| Comparison of variability of 18 measurements of DBP by self-measurement, between inclusion and after 3 months of CPAP treatment | Patients will have a connected blood pressure monitor and will be asked to make self-measurements at baseline and at 15 days, 1 month, 2 months, and 3 months after starting CPAP. | baseline to 3 months | 
| Comparison of variability of 18 measurements of mean blood pressure by self-measurement, between inclusion and after 3 months of CPAP treatment | Patients will have a connected blood pressure monitor and will be asked to make self-measurements at baseline and at 15 days, 1 month, 2 months, and 3 months after starting CPAP. | baseline to 3 months | 
| Comparison of number of steps measured before initiating CPAP and at 3 months | Patients will be required to wear their connected activity monitor for one week at inclusion, and 3 months of CPAP treatment. | baseline and 3 months | 
| Evaluation of change in biological laboratory parameters | Comparison of fasting glucose between baseline and after 3 months of CPAP treatment | baseline and 3 months | 
| Evaluation of change in biological laboratory parameters | Comparison of lipid profile between baseline and after 3 months of CPAP treatment | baseline and 3 months | 
| Weight variation over three months | Weight will be recorded using their connected devices at baseline, and 3 months of CPAP treatment. | baseline and 3 months | 
| Assessment of reasons for refusal of digital health by a dedicated questionnaire conducted in patients who refused to participate in the study | Thirteen questions about: sex, age, professional status, employment situation, smartphone usages, frequency of smartphone use, connected devices and opinions on this. | baseline | 
| Comparison of residual AHI between Polylink respiratory polygraphic data and AHI measurement by CPAP S.Box | After 3 months of treatment by CPAP the patient will have a home polygraphy using the Polylink polygraph | 24 hours | 
| Analysis of responses to a specific usability questionnaire | Eight questions for each connected device and the smartphone application : Level of difficulty in using the connected devices and application? Level of clarity of instructions for use of these connected devices? How much benefit is there from using this type of connected device? Would the patient be willing to pay € 50 or € 100 to keep the device after the study? Does the patient feel confident using connected devices? Has the association of these devices connected to CPAP been proven beneficial? Does the patient think it is necessary to associate connected devices in the management of OSAS? Does the functionality of 3 connected objects and the Sefam Access smartphone application meet the patient's requirements? | 3 months | 
| Epworth sleepiness scale (ESS) | The ESS is a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 sub-item scores( 0-3) can range from 0 to 24. The higher the ESS score the greater the likelihood that the person has daytime sleepiness. The questionnaire takes no more than 2 or 3 minutes to answer. | baseline and 3 months | 
| Pichot fatigue scale (PWS) | This is a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 5-point scale (0-4), any habitual feeling of tiredness or weakness while engaged in eight different activities. The Pichot score (the sum of the 8 item sub-scores (0-4) can range from 0 to 32.The higher the score, the more likely that the person suffers from fatigue/ chronic tiredness. The questionnaire takes no more than 2 or 3 minutes to answer. | baseline and 3 months | 
| Assessment of health-related quality of life using the EQ-5D questionnaire | This questionnaire covers five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The scores for these five dimensions can be presented as a health profile or can be converted to a single summary index number | baseline and 3 months | 
| Analysis of all primary and secondary outcome measures at 1 year | At the end of the first 3 months of the study, the connected devices will be left for the patients who will be encouraged to continue using them. Reminders will be sent via the via Sefam Access application at 6, 9 and 12 months to encourage the patient to weigh themselves self, measure their blood pressure and to wear their Actimeter (activity monitor)for 1 week. | 1 year | 
| Predictive factors of CPAP adherence at three-months | Compliance data on CPAP use will be automatically collected by CPAP telemonitoring | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous positive airway pressure, Connected devices