A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- CPAP Therapy Adherence
研究概览
简要总结
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire. The data collected from this trail allows for closer monitoring of at-risk patients. For the study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA. Participants will be provided with a GSM (Global System for Mobile communication) modem to allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30 and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the GSM unit is returned, and participants continue with CPAP therapy as instructed by their healthcare provider.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 18years of age
- •Diagnosed with OSA (AHI >5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements
- •Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years
排除标准
- •Contraindicated for CPAP therapy
- •Medically unstable condition/diagnosis that is not yet under control
- •Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
- •PLMA (Periodic Limb Movement Activity) Index greater than 15/hr
- •Home titration of longer than 5 days
结局指标
主要结局
CPAP Therapy Adherence
时间窗: 90 days
Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.
次要结局
未报告次要终点