Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): a Prospective Intervention (SLEEPCONNECT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Comparison of mean value of 18 self measures blood pressure
研究概览
简要总结
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.
详细描述
"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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CPAP S.Box associated with its 3 connected devices
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.
干预措施: CPAP associated with connected devices: blood pressure monitor , scales and activity monitor (Other)
结局指标
主要结局
Comparison of mean value of 18 self measures blood pressure
时间窗: baseline and 3 months
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.
次要结局
- Comparison of variability of 18 measurements of SBP by self-measurement, between inclusion and after 3 months of CPAP treatment(baseline to 3 months)
- Assessment of reasons for refusal of digital health by a dedicated questionnaire conducted in patients who refused to participate in the study(baseline)
- Comparison of residual AHI between Polylink respiratory polygraphic data and AHI measurement by CPAP S.Box(24 hours)
- Assessment of health-related quality of life using the EQ-5D questionnaire(baseline and 3 months)
- Comparison of number of steps measured before initiating CPAP and at 3 months(baseline and 3 months)
- Predictive factors of CPAP adherence at three-months(3 months)
- Comparison of variability of 18 measurements of DBP by self-measurement, between inclusion and after 3 months of CPAP treatment(baseline to 3 months)
- Weight variation over three months(baseline and 3 months)
- Pichot fatigue scale (PWS)(baseline and 3 months)
- Evaluation of change in biological laboratory parameters(baseline and 3 months)
- Comparison of variability of 18 measurements of mean blood pressure by self-measurement, between inclusion and after 3 months of CPAP treatment(baseline to 3 months)
- Analysis of responses to a specific usability questionnaire(3 months)
- Analysis of all primary and secondary outcome measures at 1 year(1 year)
- Epworth sleepiness scale (ESS)(baseline and 3 months)