Clinical trial NCT04054180: Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): (SLEEPCONNECT)
Official title: Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): a Prospective Intervention (SLEEPCONNECT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Continuous positive airway pressure
Connected devices
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: SEFAM MEDICAL (Villiers les Nancy, France)
First posted: 2019-08-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, open, multicentric, national and uncontrolled study.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of mean value of 18 self measures blood pressure
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Comparison of variability of 18 measurements of SBP by self-measurement, between inclusion and after 3 months of CPAP treatment
timeFrame: baseline to 3 months
measure: Comparison of variability of 18 measurements of DBP by self-measurement, between inclusion and after 3 months of CPAP treatment
timeFrame: baseline to 3 months
measure: Comparison of variability of 18 measurements of mean blood pressure by self-measurement, between inclusion and after 3 months of CPAP treatment
timeFrame: baseline to 3 months
measure: Comparison of number of steps measured before initiating CPAP and at 3 months
timeFrame: baseline and 3 months
measure: Evaluation of change in biological laboratory parameters
timeFrame: baseline and 3 months
measure: Evaluation of change in biological laboratory parameters
timeFrame: baseline and 3 months
measure: Weight variation over three months
timeFrame: baseline and 3 months
measure: Assessment of reasons for refusal of digital health by a dedicated questionnaire conducted in patients who refused to participate in the study
timeFrame: baseline
measure: Comparison of residual AHI between Polylink respiratory polygraphic data and AHI measurement by CPAP S.Box
timeFrame: 24 hours
measure: Analysis of responses to a specific usability questionnaire
timeFrame: 3 months
measure: Epworth sleepiness scale (ESS)
timeFrame: baseline and 3 months
measure: Pichot fatigue scale (PWS)
timeFrame: baseline and 3 months
measure: Assessment of health-related quality of life using the EQ-5D questionnaire
timeFrame: baseline and 3 months
measure: Analysis of all primary and secondary outcome measures at 1 year
timeFrame: 1 year
measure: Predictive factors of CPAP adherence at three-months
timeFrame: 3 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: UniversityHospitalGrenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis JLP Pépin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Montpellier
name: Dany DJ Jaffuel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique de la Louvière SELARL SPIRAL, Lille
name: Thibaut TG Gentina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: Frédéric FG Gagnadoux, PhD
role: PRINCIPAL_INVESTIGATOR
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