Diagnosis of Sleep-Related Respiratory Disorders in Patients With Narcotic Medications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Accuracy of Central Sleep Apnea Events
研究概览
简要总结
The present study is a prospective, single cohort study involving patients on narcotic medications, undergoing overnight sleep studies in the clinical sleep laboratory. The main hypothesis for the study is that the the frequency of sleep respiratory events (including central apneas) identified by a home sleep apnea test (HSAT) device (WatchPAT200U (wp200U) with centrals; Itamar Medical Ltd.) will significantly correlate with in-lab polysomnography (gold standard).
详细描述
Background
Opioid use in the United States has escalated on an unprecedented scale since 1997, when the American Academy of Pain Medicine and the American Pain Society issued a statement declaring that respiratory depression typical to opioid use is a significant concern. The Trends and Risks of Opioid Use for Pain (TROUP) study demonstrated a broad-based increase in the use of potent opioids in publicly and privately insured enrollees between 2000 and 2005. Their findings suggest a significant liberalization in opioid use for non-cancer pain that is not limited to one geographic region or socioeconomic group.
Chronic use of opioid medication' (i.e., longer than 6 months) predisposes patients to the development of an irregular breathing pattern with central apneas during sleep, best characterized as Biot's respiration, ataxic breathing. Ataxic breathing is characterized by a breathing pattern in which there are groups of similar sized breaths alternating with regular periods of central apnea.
The WatchPAT HSAT device and polysomnography are both standard diagnostic tests for sleep disordered breathing, in particular for obstructive sleep apnea. However, the WatchPAT has never been validated in regards to its diagnostic accuracy pertaining to narcotic-induced central apneas.
This study has important implications to the medical field and patients for the following reasons:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kaiser Permanente member
- •Patient is able to read, understand and sign the informed consent form.
- •Subject on current narcotic prescription with of at least 4 nights/week (subject will be asked on night of PSG if they took narcotic medication and specific medication taken)
排除标准
- •Finger deformity that precludes adequate sensor appliance
- •Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)
- •Patients that are oxygen dependent
- •Patients with Chronic Obstructive Pulmonary Disease (COPD) with FEV1 <70%, obesity hypoventilation syndrome, neuromuscular weakness
研究组 & 干预措施
WatchPAT 200 and In-Lab Study
Patients who are referred to the sleep center for an overnight study that are narcotic users will be offered to the opportunity to participate in the study. Patients who fulfill the inclusion exclusion criteria and have given informed consent will undergo a standard in-lab polysomnography while simultaneously wearing the WatchPAT200 device.
干预措施: WatchPAT 200 (Diagnostic Test)
结局指标
主要结局
Accuracy of Central Sleep Apnea Events
时间窗: 1 year
Compare the efficacy of the WatchPAT200 in detecting narcotic based central respiratory events to the manual scoring of the in-lab polysomnography that serves as a "gold standard".
Accuracy of Other Various Sleep Metrics
时间窗: 1 year
Compare the efficacy of the WatchPAT200 in detecting narcotic based oxygen, body position, and sleep-wake events to the in-lab polysomnography.
次要结局
未报告次要终点
研究者
Dennis Hwang, MD
Co-Chair, Sleep Medicine, Kaiser Permanente Southern California
Kaiser Permanente