Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 556
- 试验地点
- 22
- 主要终点
- CPAP treatment adherence
研究概览
简要总结
Adherence to CPAP determines the expected benefits of the treatment. A dose-benefit relationship has been demonstrated for both functional and cardiovascular benefits. The first few days' use of the device are decisive in determining long-term compliance. In this context, daily monitoring of the data teletransmitted means that we can be more responsive to problems of compliance during the first few days of use; the contribution of telemonitoring can be very positive in a context of poor compliance.
In France, compulsory health insurance coverage of CPAP treatment is authorised for patients aged over 16 with clinical symptoms and an AHI ≥15 events per hour and <30 events/h in patients with severe cardiovascular co-morbidity. These patients are often not very sleepy due to sympathetic hypertonia with a shorter sleep duration. They are at high risk of non-compliance.
The IPIAM study specifically targets a population at cardiovascular risk and at high risk of non-compliance with CPAP treatment. The IPIAM study aims to involve patients in the success of their treatment via remote monitoring and to show that this approach makes it possible to improve the handling of alerts and to participate in the therapeutic support of the patient. Finally, this population also shares the risk of heart rhythm disorders. As part of a cross-disciplinary inter-pathology telemonitoring approach, it also makes sense to screen for cardiac rhythm disorders by wearing a connected watch.
详细描述
IPIAM is a prospective randomized controled study with two arms. Two approaches to telemonitoring will be compared: the standard telemonitoring carried out by the home healthcare provider (standard of care) will be compared with a new approach in which the patient is involved in managing his treatment by collecting vitals and notifying alerts via two connected devices (a connected watch and a mobile application).
The study will comprise 2 phases :
- an initial interventional, comparative, randomised phase corresponding to the first 4 months of CPAP treatment,
- an observational period with standard telemonitoring, lasting until the 12th month of treatment.
In this study, all patients will be treated with the same continuous positive airway pressure ventilator (AirSense 11 Autoset, ResMed).
CPAP alerts will be checked by the home healthcare provider's technicians every week and then managed differently depending on the randomisation group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult with newly diagnosed OSA (with central apnea index <5 ev/h), justifying CPAP and with low sleepiness (Epworth score <11 at inclusion).
- •Patient with at least 1 cardiovascular risk factor (obesity, type I or II diabetes with or without treatment, permanent hypertension with or without treatment, heart failure with preserved ejection fraction, valve disease, history of atrial fibrillation, history of ischaemic heart disease, history of stroke).
- •Patient with a smartphone and who agrees to use connected objects during the study.
- •Signed informed consent form,
- •Subject affiliated to a health insurance system, or is a beneficiary.
排除标准
- •Patients already fitted with a CPAP machine,
- •Patients with permanent atrial fibrillation,
- •Patients whose state of health is not stable or requires heavy treatment,
- •Patients with cognitive problems.
- •Patients participating in another intervention research in pulmonology.
- •Vulnerable subject
研究组 & 干预措施
Standard CPAP telemonitoring
Patients are treated with CPAP and the home healthcare provider carries out monitoring in line with current practice (telemonitoring of treatment and regular home visits).
New CPAP telemonitoring approach
Patients are treated with CPAP and the home healthcare provider is offering a new approach to remote monitoring in which patients are involved in managing their CPAP treatment using two connected devices (the Scanwatch connected watch + the mobile application Asten&masanté) in the first 4 months of treatment.
干预措施: New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application (Device)
结局指标
主要结局
CPAP treatment adherence
时间窗: Month 4
Measurement of the average daily duration of use of the CPAP (expressed in hours) over the last 30 nights, 4 months after initiation of treatment. The duration of use will be compared between both groups.
次要结局
- Quality of CPAP treatment assessed by leaks(Month 1, Month 2, Month 3, Month 4)
- Quality of CPAP treatment assessed by apnea hypopnea index(Month 1, Month 2, Month 3, Month 4)
- long term CPAP treatment adherence(Month 6, Year 1)
- Number of nights with Cheynes Stoke Respirations (CSR)(over the first 4 months)
- Nocturnal heart rate(over the first 4 months)
- Number of alerts(over the first 4 months)
- Number of medical events (pneumology and cardiology consultations, hospitalizations) related to OSA(Month 4)
- F-SUS questionnaire(Month 4)
- Number of home healthcare provider interventions(over the first 4 months)
- Quality of CPAP treatment assessed by leaks(Month 1, Month 2, Month 3, Month 4)
- Quality of CPAP treatment assessed by apnea hypopnea index(Month 1, Month 2, Month 3, Month 4)
- long term CPAP treatment adherence(Month 6, Year 1)
- Number of nights with Cheynes Stoke Respirations (CSR)(over the first 4 months)
- Nocturnal heart rate(over the first 4 months)
- Number of alerts(over the first 4 months)
- Number of medical events (pneumology and cardiology consultations, hospitalizations) related to OSA(Month 4)
- F-SUS questionnaire(Month 4)
- Number of home healthcare provider interventions(over the first 4 months)