Sleep-Disordered Breathing in Chronic SCI
Sleep-Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease
研究概览
详细说明
Investigators will examine the effect of PAP therapy and sleep apnea on thinking (especially memory, learning and concentration), sleep quality, and risks for future heart (cardiovascular) problems in persons with chronic spinal cord injury (SCI).
SDB is a condition where there are pauses in breathing or shallow breathing during sleep due to airway narrowing. This leads to low oxygen levels during sleep and sleep disruption. The usual treatment for sleep apnea is PAP (Positive Airway Pressure) worn while sleeping. This involves the use of usually a mask connected to a machine that supplies enough pressure to keep the airway open during sleep.
SDB will be diagnosed in SCI participants using unattended portable level II polysomnography (PSG) (a portable at home sleep study for one night).
Sleep quality (SQ), SDB risk, insomnia severity, daytime sleepiness,and mood will be measured using questionnaires.
Cognitive evaluations will be completed prior to randomization on all participants who also complete a portable PSG to evaluate general and pre-morbid function, immediate verbal memory, simple and sustained attention, processing speed, and executive function.
Blood and urine samples will be taken for participants with SDB diagnosis after randomization.
All randomized subjects will be fitted with a nasal or full-face mask and head gear. PAP will be delivered by an auto-titrating device. These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas, and hypopneas. All subjects will be instructed to use the device nightly during sleep, for the ensuing four months. All outcome measurements will be reassessed after four months of PAP.
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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Florida
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Miami、Florida、美国、33125
- Miami VA Hospital
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Miami、Florida、美国、33136
- Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
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Michigan
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Detroit、Michigan、美国、48201
- Wayne State University
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Detroit、Michigan、美国、48201
- John D Dingell VA Medical Center
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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:
- Chronic tetraplegia or paraplegia (C4-L1)
- American Spinal Injury Association (ASIA) Impairment Scale A, B, C or D
- 18 years and older
- At least one year post injury
- Hearing and vision suitable for comprehension of instructions, and perception of cognitive test stimuli
- No color blindness as measured by a brief screen with color perception Ishihara cards
- Stable medical condition for 2 weeks prior to enrollment. Patients admitted to hospital will be eligible for enrolment if the acute illness precipitating admission is in recovery phase for 2 weeks or longer
Exclusion Criteria:
- Diagnosis of SDB and successful positive airway pressure (PAP) therapy prior to injury. Those with a diagnosis of SDB post injury who are not receiving therapy for SDB (PAP, surgical, and/or oral appliance) are eligible for study enrollment
- Patients who are intubated, have a tracheostomy, and/or are using long term invasive/non-invasive positive pressure ventilation
- Participants with predominant central sleep apnea on PSG requiring bi-level PAP therapy
- Severe traumatic brain injury (GCS < 8 at first assessment)
- Unable to understand or read English at a grade 5 level
- Inability to provide informed consent
- Evidence of advanced neurological or systemic disease that may affect cognitive functioning (e.g., Alzheimer's disease, Dementia, Parkinson's disease)
- Significant aphasia or language impairments
- Positive airway pressure therapy may be contraindicated in some patients with the following preexisting conditions:
- severe bullous lung disease
- pneumothorax
- pathologically low blood pressure
- dehydration
- cerebrospinal fluid leak, recent cranial surgery, or trauma.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:AutoPAP
PAP treatment will be delivered for four months by an auto-titrating device (IntelliPAP AutoAdjust®).
These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.
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PAP will be delivered by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas. AutoPAP treatment 7 nights a week for four months (16 weeks).
其他名称:
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假比较器:Sham PAP
Sham PAP treatment will be delivered for four months by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events.
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Sham PAP treatment will be delivered by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events. The pressure is too low to eliminate respiratory events and serves as sham or sub-therapeutic PAP. Sham PAP treatment 7 nights a week for four months (16 weeks)./ |
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 |
|---|---|---|
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Cognitive Functioning as Measured by PASAT
大体时间:16 weeks
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Paced Serial Addition Test (PASAT) measures divided attention and memory.
PASAT has a total score ranging from 0 to 60 with the lower scores indicate greater impairment of attention.
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16 weeks
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合作者和调查者
调查人员
- 首席研究员:Shirin Shafazand, MD, MS、University of Miami Miller School of Medicine; Pulmonary and Critical Care Medicine
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 (实际的)
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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