Remote Monitoring in Obstructive Sleep Apnea
Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans
研究概览
地位
条件
详细说明
Prior to enrollment, patients were seen by a clinician at the Veterans Administration (VA) Hospital in West Haven, Connecticut. Either a facility-based diagnostic polysomnogram or unattended home sleep testing was performed at the evaluating clinician's discretion. Clinicians that saw the patient determined whether PAP therapy was needed, and either auto-titrating continuous positive airway pressure (CPAP) or set pressures of CPAP were ordered for the patient. Patients received education about OSA and about their equipment from a respiratory therapist and physician's assistant within the VA who then provided the equipment for them. Patients coming to this internal Durable Medical Equipment (DME) provider were screened for participation in the study.The study was overseen by the Institutional Review Board at the Veterans Affairs Connecticut Health Care in West Haven, Connecticut. Informed consent was obtained from all participants.
Patients were included in the study if they were diagnosed with OSA (defined as AHI or apnea-hypopnea index greater than five per hour with symptoms, or AHI greater than 15/hour), and if they were being exposed to PAP for the first time. Patients who were previously treated with PAP, had central apnea, chronic respiratory failure, recent in-patient hospital admissions (=< 2 weeks), or were living outside cellular network coverage area were excluded from the study.
Patients that met study inclusion criteria were provided ResMed S9 devices with wireless modems. Their usage and treatment data was tracked using EasyCare Online, a cloud-based system for the ResMed devices. After the initial setup and educational settings, the patients received supplies as needed and troubleshooting of side effects of treatment as needed. Devices were not removed after 3 months if they were not adherent.
Patients in the usual care group were monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data were only assessed by the clinician at these intervals.
Patients in the wireless care group were monitored more frequently using wireless modems as the method to obtain adherence and efficacy data.
We then determined adherence using CMS (Centers for Medicare & Medicaid Services) criteria at 3 months, and at 12 months. To obtain this data, we evaluated whether the PAP devices were used for 4 or more hours per night on 70% of nights during a consecutive 30-day period anytime during the first 3 months of initial use, and then a consecutive 30-day period in months 4-12. We also examined the daily use from the first to last day looking of overall patterns of utilization monthly, quarterly, semiannually and annually. Data was collected and maintained in a REDCap database (REDCap is a secure web application for building and managing online surveys and databases). Sensitivity and specificity calculations were then performed to evaluate predictability of adherence at 1 year using adherence at 3 months. Fisher's exact test was also used to evaluate the association between adherence at 3 months and 1 year and the association between AHI (Apnea -Hypopnea Index) and adherence.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Connecticut
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West Haven、Connecticut、美国、06516
- VA Connecticut Health System
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Newly diagnosed OSA patients
- AHI of 5/hour or greater
- Prescribed CPAP therapy
- Able to comply with treatment and understand treatment instructions
Exclusion Criteria:
- Not able to understand study requirements
- Significant cardiorespiratory disease - e.g. COPD (chronic obstructive pulmonary disease), severe CHF (congestive heart failure)
- Clinical instability at time of apnea diagnosis
- Prescribed BiPap (bilevel positive airway pressure) or ASV (Adaptive Support Ventilation), which are other types of PAP
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Usual Care
Monitoring every 3 months by face-to-face visits:These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits.
Adherence and efficacy data will only be assessed by the clinician at these intervals.
|
These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits.
Adherence and efficacy data will only be assessed by the clinician at these intervals.
|
|
有源比较器:Wireless Care
Frequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.
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These patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months
大体时间:First 3 months
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Positive Airway Pressure Treatment Adherence defined as mean PAP use being > 4 hours per night for greater than 70% of nights.
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First 3 months
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Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months
大体时间:4-12 Months
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Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being > 4 hours per night for greater than 70% of nights
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4-12 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Receiving Effective Treatment for Obstructive Sleep Apnea
大体时间:12 months
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Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.
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12 months
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合作者和调查者
调查人员
- 首席研究员:Meir Kryger, MD、VA Connecticut Healthcare System
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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