Effects of an Early Combination of Automated Electronic and Telemedical Support on the Therapeutic Results of CPAP and APAP Patients and as a Supplement to (Tele-) Medical Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Daytime sleepiness (ESS Score)
研究概览
简要总结
Obstructive sleep apnea (OSA) is a type of sleep-related breathing disorders that is characterized by a sleep-related constriction (obstruction) of the upper airways. The treatment with continuous application of positive airway pressure (CPAP) via respiratory mask forms the therapeutical standard of OSA. The autoCPAP (automatic positive airway pressure: APAP) therapy is an additional treatment option for patients with more unstable conditions (e.g. due to sleep position) which is characterized by a dynamic adaption of the applied airway pressure according to patients therapeutical needs. Device usage time and therapy adherence are crucial for treatment success.
The purpose of this study is to assess the effect of a digital patient support (DPS) tool, complementary to standard care on continuous and automatic positive airway pressure (CPAP, APAP) adherence and daytime sleepiness after 12 weeks in patients diagnosed with severe obstructive sleep apnea (OSA).
All patients with apnea-hypopnea index (AHI) ≥ 30 per hour are prospectively included and randomized to receive standard care (SC) or standard care with personalized DPS via prisma APP prototype version (SC+DPS). In both arms, initiation of therapy and standardized therapy control after 12 weeks is carried out identically. Patients in the SC+DPS arm received additionally automated feedback on their therapy and motivational messages, as well as therapy recommendations.
详细描述
Clinical Picture From the epidemiological view obstructive sleep apnea (OSA) is the most common type of sleep-related breathing disorders (SRBD). OSA is characterized by a sleep-related constriction (obstruction) of the upper airways that in adulthood is often caused by a neuromuscular related impairment of the pharyngeal tone. OSA is linked to many negative health consequences and is associated with a large number of comorbidities.
General treatment As a rule SRBD are treated with appropriate therapy devices that transmit positive airway pressure (PAP) via respiratory masks. In the case of the treatment of obstructive sleep apnea (OSA) therapeutical standard is formed by application of continuous positive airway pressure (CPAP). CPAP therapy devices provide a stable positive airway pressure during sleep to prevent the upper airway obstructions. The determination of the essential airway pressure that keeps airways open takes place within the therapy setting night in the sleep laboratory under polysomnographic monitoring. Patients with more unstable pressure needs, e.g. based on position shifts during the night, also qualify for an autoCPAP (APAP) therapy. APAP therapy devices adapt the applied airway pressure dynamically within defined ranges according to patients' therapeutical needs. Therapy success is essentially defined by average device usage time and patients' long-term therapy adherence which in term is affected by a broad variety of factors. The identification of these factors therefore lead to the development of different treatment strategies to improve patients' therapy adherence.
Usual therapeutical process Patients with suspected OSA are surveyed according to their symptomatology and receive a sleep medical examination under polygraphical or polysomnographical observation. During the sleep medical examination numerous cardiorespiratory and somnological signals are recorded and evaluated.
As far as the evaluation of the recorded signals leads to the diagnosis of OSA and no indications for another type of PAP therapy are present, the adjustment to CPAP or APAP therapy under polysomnographical observation takes place immediately after diagnosis.
Following this, patients receive an appropriate adjusted CPAP- or APAP therapy device and get introduced in it´s handling to continue therapy by themselves in their home environment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years
- •CPAP-naïve
- •confirmed severe OSA (AHI >30/h), diagnosis based on polysomnography (PSG) (MiniScreen PRO with Software MiniscreenViewer, Dr. Fenyves & Gut, Rangendingen, Germany)
- •written informed consent to participate in the study, including a data protection statement.
排除标准
- •presence of a contraindication to PAP therapy
- •participation in another study influencing automated electronic support
- •lack of possibility to receive emails or use electronic means of communication
- •lack of patient consent.
结局指标
主要结局
Daytime sleepiness (ESS Score)
时间窗: Baseline and after 12 weeks (Diagnosis/ baseline to therapy control)
Significant change in daytime sleepiness of CPAP/ APAP patients with standard care plus support of a digital patient support (DPS) tool versus patients with standard care without support of a digital patient support (DPS) tool from baseline at therapy control after 12 weeks
次要结局
- Therapy efficacy(Within 12 weeks (period between diagnosis/ baseline to therapy control))
- Therapy adherence(Within 12 weeks (period between diagnosis/ baseline to therapy control))
- satisfaction with therapy and care according to standardized survey(up to 12 weeks)
- Investigation of frequency of usage of the DPS (Digital Patient Support) tool in the intervention group(Within 12 weeks (period between diagnosis/ baseline to therapy control))
- Investigation of type of usage of the DPS (Digital Patient Support) tool in the intervention group(Within 12 weeks (period between diagnosis/ baseline to therapy control))
- Investigation of the drop out rate, especially impact of therapy break-off(up to 12 weeks)
- type and frequency of usage of device comfort features(Within 12 weeks (period between diagnosis/ baseline to therapy control))
- Investigation of progress of therapy adherence, therapy efficacy and side effects in the intervention group(Within 12 weeks (period between diagnosis/ baseline to therapy control))
- Correlation between secondary variables and primary variable to investigate the impact of secondary variables on the primary outcome(up to 12 weeks)