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.
"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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
41
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.
UniversityHospitalGrenoble
Grenoble, France
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.
Time frame: baseline and 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 3 months
Evaluation of change in biological laboratory parameters
Comparison of fasting glucose between baseline and after 3 months of CPAP treatment
Time frame: baseline and 3 months
Evaluation of change in biological laboratory parameters
Comparison of lipid profile between baseline and after 3 months of CPAP treatment
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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?
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 1 year
Predictive factors of CPAP adherence at three-months
Compliance data on CPAP use will be automatically collected by CPAP telemonitoring
Time frame: 3 months
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