Sleep-Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Cognitive Functioning as Measured by PASAT
研究概览
简要总结
The purpose of this study is to examine impact of Sleep Disordered Breathing (SDB) treatment in persons with chronic Spinal Cord Injury (SCI). The central hypothesis is that the treatment of SDB with Positive Airway Pressure (PAP) will improve cognition, sleep quality, health related quality of life (HRQOL), pain and Cardiovascular Disease (CVD) surrogate measures in persons with chronic SCI.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Cognitive Functioning as Measured by PASAT
时间窗: 16 weeks
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.
次要结局
未报告次要终点
研究者
Shirin Shafazand
Associate Professor of Medicine
University of Miami