Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months
研究概览
简要总结
Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to the patient in terms of serious co-morbidities and results in a great cost to the VA Health Care System to treat the co-morbidities, which include heart disease, stroke and neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and studies have shown a poor adherence to treatment. The investigators hypothesize that using wireless technology will lead to early detection of problems of treatment use and will translate into early remedial action which will improve the use and effectiveness of treatment. The investigators will compare two methods. Usual care involves downloading data from PAP machines at designated 3-month intervals, requiring a face-to-face clinician visit. Wireless care involved more frequent monitoring and intervention in the event of anomalies in treatment use or effectiveness.
详细描述
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.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed OSA patients
- •AHI of 5/hour or greater
- •Prescribed CPAP therapy
- •Able to comply with treatment and understand treatment instructions
排除标准
- •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
结局指标
主要结局
Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months
时间窗: First 3 months
Positive Airway Pressure Treatment Adherence defined as mean PAP use being \> 4 hours per night for greater than 70% of nights.
Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months
时间窗: 4-12 Months
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
次要结局
- Receiving Effective Treatment for Obstructive Sleep Apnea(12 months)