Effects of Telemedicine and Humidification for Continous Positive Airway Pressure (CPAP) in OSAS.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- CPAP usage
研究概览
简要总结
The goal of the study is to test the role of telemedicine combined with humidification to check CPAP treatment during the first month to improve adherence and reduce unsolved side effects of therapy.
详细描述
The primary goal of OSAS therapy is to obtain CPAP adaptation for the highest amount of OSAS patients to reduce the proportion of untreated OSAS in the population. This object is important considering that a longer duration of CPAP treatment is linked with better daytime functioning and metabolic and blood pressure effects of CPAP. The main endpoints will be CPAP usage (defined as the proportion of night with CPAP usage ≥1h); CPAP adherence (defined as the proportion of night with CPAP usage ≥4h); the average nightly usage of CPAP (hour/night); CPAP efficacy (defined as AHI and ESS score). Each measure will be performed after 1 week, 1 month and 6 months.
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
- •Consecutive symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of >15/h in polysomnography (PSG) or Home Sleep Test (HST) consenting to start long term CPAP treatment.
排除标准
- •Age <18 years
- •Unable to communicate in Italian
- •Previous usage of CPAP treatment
- •Alcohol consumption > 4 units >4 times a week
- •Acute manifestation of psychiatric diseases
- •Life expectancy of < 6 months for any reason
- •Surgical obesity treatment planned within the next 6 months
- •Predominantly Central sleep apnea and cheyne stokes respiration
研究组 & 干预措施
Telemedicine & Humidification Intervention
In the telemedicine intervention arm, a telemetry device is instructed and attached to the CPAP. Patients are instructed to use CPAP every night. Data of the CPAP are downloaded to the internet once daily. On week days, a nurse/sleep technologist is checking the downloaded data three times per week. The contacts will be due to:
- CPAP usage <4h/ night for 3 consecutive night
- the median leakage was above 0.4 L/sec on 3 consecutive nights The nurse/sleep technologist informs the patient of the problem observed, asks for explanations and gives advice on possibilities to solve the problem. The common problems and the respective solutions (Dry mouth/throat, nasal congestion, skin irritation, conjunctivitis, headache, loss of benefits) will be discussed. The patient is encouraged to use CPAP every night. In the case of adherence >4h/night and acceptable leakage, a congratulatory message is sent to the patient via sms or e-mail.
干预措施: Telemedicine & Humidification (Device)
Control without Telemedicine & humidification
In the control arm, no wireless telemedicine and humidifier will be used with CPAP but data stored in the CPAP machine are collected at the follow-up visit after 1 month
结局指标
主要结局
CPAP usage
时间窗: 6 months
defined as the proportion of night with CPAP usage ≥1h
CPAP adherence
时间窗: 6 months
defined as the proportion of night with CPAP usage ≥4h
CPAP usage
时间窗: 1 week
defined as the proportion of night with CPAP usage ≥1h
CPAP usage
时间窗: 1 month
defined as the proportion of night with CPAP usage ≥1h
CPAP adherence
时间窗: 1 week
defined as the proportion of night with CPAP usage ≥4h
CPAP adherence
时间窗: 1 month
defined as the proportion of night with CPAP usage ≥4h
次要结局
- average nightly usage of CPAP(6 months)
- average nightly usage of CPAP(1 week)
- average nightly usage of CPAP(1 month)
研究者
Andrea Romigi
MD PhD
Neuromed IRCCS