NCT05246449已完成不适用
Multi-centre, National, Randomised, Exploratory Study Evaluating the Benefit of an Individualised Treatment Plan(VitalCare) Compared to Standard of Care, in Obstructive Sleep Apnoea Patients Treated With CPAP/APAP
Air Liquide Santé International1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2022年2月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- CPAP/APAP adherence evaluation
研究概览
简要总结
According to a stratification procedure, the objective of a personalised care plan (VitalCare) is to identify points for improvement since the early stage of the patient's pathway of CPAP/APAP treatment and to adjust patient follow-up .
详细描述
It is a prospective, exploratory, randomised, multi-centre, open, controlled study with a 1:1 ratio of two parallel groups, with obstructive sleep apnoea patients starting CPAP/APAP therapy, and receiving by the homecare provider, either an individualised treatment plan (VitalCare) or national standard of care.
This study will be conducted in 5 hospital centres in Portugal..
During a regular medical consultation, eligible patients who have signed their informed consent will be randomised by their investigator.
Two study groups will be set up:
- Standard of care group
- VitalCare group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Patient diagnosed with Obstructive Sleep Apnoea Syndrome (OSAS) who is newly prescribed CPAP or APAP therapy at inclusion
- •Patient agreeing to the collection of data from their CPAP/APAP device via teletransmission
- •Patient equipped with a device compatible with the ResMed telemonitoring data platform
- •Patient who has signed the informed consent form for the study
排除标准
- •Obese patient presenting hypoventilation
- •Patient at risk of other sleep disorders (e.g. severe insomnia)
- •Patient with physical, mental or cognitive inability to use all components of the remote medical monitoring project and individualised treatment plan, as determined by the investigator wishing to include the patient
- •Patient with severe COPD (FEV1 ≤ 50% predicted or modified Medical Research Council (mMRC) dyspnoea scale > 2)
- •Patient with severe Chronic Heart Failure (NYHA stage III or IV)
- •Patient's refusal of CPAP/APAP treatment support
- •Previous CPAP/APAP treatment for Sleep Apnoea
- •Patient with ongoing Mandibular Advancement Device (MAD) or in the 12 previous months
- •Patient with no permanent place of residence
- •Patient participating in another drug or device study within the previous 30 days
结局指标
主要结局
CPAP/APAP adherence evaluation
时间窗: 3rd month
average daily number of hours of CPAP/APAP use at 3 months
次要结局
- adherence to CPAP/APAP(1st, 6th,12th months)
- evolution of daily Apnoea-Hypopnoea Index (AHI) and Non intentional leaks level teletransmitted by CPAP/APAP devices(1st, 3rd, 6th,12th months)
- adverse events description(through study completion, an average of 1 year)
- daytime sleepiness(1st, 3rd, 6th,12th months)
- For patients in the VitalCare group, Balachandran CPAP perception questionnaire(1st, 3rd, 6th,12th months)
- Number of contacts between home healthcare provider and patient(1st, 3rd, 6th,12th months)
- For patients in the VitalCare group, number of updates of the individualised treatment plan(1st, 3rd, 6th,12th months)
- Snoring and Quality of Life(1st, 3rd, 6th,12th months)
研究者
研究点 (1)
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