Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA) complicated by central sleep apnea (CSA) due to the chronic use of opioid medications
详细描述
The trial seeks to determine the efficacy and patient comfort of ASV and bi-level positive airway pressure (PAP) modes for the treatment of obstructive sleep apnea (OSA), complicated by CSA secondary to opioid use. Subjects will be randomized to one of two groups, utilizing a cross-over design to evaluate the two modes with the subject as their own control.
Subjects will be asked to undergo two PSG studies; one with ASV titration and one with bi-level treatment, using the current pressure prescription. The study comprises two visits. Subjects will be asked to complete patient satisfaction questionnaires following their PSG studies. It is anticipated that total subject participation will be no longer than one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •At least 18 years old
- •Taking opioid medications for at least 6 months. Opioid medications include but are not limited to: oxycodone, fentanyl, methadone, levorphanol, hydromorphone, and morphine
- •Using bi-level PAP for at least 30 days
排除标准
- •Primary heart or lung disease, for example: chronic obstructive pulmonary disease, pulmonary fibrosis, severe heart failure, uncorrected congenital heart disease, pulmonary hypertension
- •Primary neurologic disease, for example: neuromuscular disease, previous stroke or cognitive impairment
- •Narcolepsy
- •Acute upper respiratory tract infection
研究组 & 干预措施
Adaptive Servo-Ventilation (ASV) then BiLevel PAP
Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
干预措施: Adaptive servo-ventilation (ASV) (Device)
Adaptive Servo-Ventilation (ASV) then BiLevel PAP
Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
干预措施: Bi-Level PAP (Device)
Bi-Level PAP then Adaptive Servo-Ventilation (ASV)
Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
干预措施: Adaptive servo-ventilation (ASV) (Device)
Bi-Level PAP then Adaptive Servo-Ventilation (ASV)
Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
干预措施: Bi-Level PAP (Device)
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: Up to 1 month
Subjects completed 2 overnight sleep studies (polysomnography (PSG)). The Apnea Hypopnea Index (AHI) metric is collected from the PSG study. Patients were equally distributed according to the therapy used first (ASV then Bi-Level or Bi-Level then ASV).
次要结局
- Patient Comfort(Up to 1 month)