Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 668
- 试验地点
- 2
- 主要终点
- Neurocognitive function Trails A and Trails B
研究概览
简要总结
Obstructive sleep apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD) are highly prevalent chronic respiratory diseases in the Veteran population. OSA co-occurring with COPD, known as Overlap Syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in Veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.
详细描述
There are no studies regarding the impact of PAP therapy on sleep disturbance, cognitive function and quality of life in patients with OVS. The investigators' rationale is that in patients with moderate-severe OVS, PAP therapy will effectively alleviate sleepiness, sleep disturbances and cognitive deficits, and, thereby, improve QoL. 'PAP' includes either continuous positive airway pressure (CPAP) or noninvasive positive airway pressure ventilation (NIPPV).
Objectives:
Specifically, the investigators will study the effectiveness of PAP therapy vs. conservative care in reducing daytime sleepiness and in improving sleep quality and QoL in older Veterans with OVS.
The investigators will also explore whether CPAP is non-inferior to noninvasive positive airway pressure ventilation (NIPPV) in reducing daytime sleepiness, sleep disturbances and neurocognitive dysfunction, and in improving QoL in older Veterans with OVS.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography with concomitant moderate-severe COPD based on pulmonary function tests (PFTS) and with past significant history (>10 pack-years) of smoking
- •Male or female gender
- •Age greater than or equal to 60 years
- •Stable treatment regimen for COPD
排除标准
- •Current or prior treatment with PAP or oral appliance
- •Central sleep apnea defined as central apnea index >5 per hour and comprising 50% of AHI
- •Known primary neuromuscular diseases
- •Disorders that may impact cognitive function including:
- •neurodegenerative disorders
- •traumatic brain injury
- •untreated PTSD and/or history of learning disability
- •Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants as these may alter the results
- •Patient is actively suicidal due to depression, unstable mental health condition
- •Epworth sleepiness score >16 (severe sleepiness) or a near-miss or prior automobile accident due to sleepiness within the past 12 months
- •Narcolepsy is the primary sleep disorder, with requirement of stimulant medications
- •Employed as a commercial driver or operating heavy machinery
- •On long-term oxygen therapy prior to start of study, more than 12 hr/day
- •Patients is unable to use either a nasal or face mask (e.g., facial trauma, claustrophobia)
- •Consumption of >3 alcoholic beverages per day or current use of some illicit drugs, as these may contribute to cognitive deficits
- •Patients who cannot give informed consent
- •Patients receiving hospice care
- •Pregnant women due to unknown risks
研究组 & 干预措施
PAP therapy arm
PAP Therapy will be provided to eligible patients with OVS. This is the active therapy arm.
干预措施: Positive airway pressure (Device)
Conservative care (control arm)
Eligible OVS patients will receive conservative care/usual care with education about sleep apnea and sleep hygiene via handouts and video instructions. This is the control arm.
干预措施: Conservative care (control arm) (Other)
结局指标
主要结局
Neurocognitive function Trails A and Trails B
时间窗: Change from baseline at 3 and 6 months
Trails A and Trails B test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Neurocognitive function HVLT-R
时间窗: Change from baseline at 3 and 6 months
Hopkins Verbal Learning Test - Revised (HVLT-R) will be administered to evaluate Verbal learning and memory. Scored on a Standard scale of 100 +/- 15, where a higher score is a better outcome.
Quality of life FOSQ
时间窗: Change from baseline at 3 and 6 months
Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire FOSQ/(FOSQ). There are 5 subscale domains of the FOSQ (General Productivity, Social Outcome, Activity Level, Vigilance, and Intimate Relationships and Sexual Activity). There all range from 0-20, where a higher value is a better outcome. The total FOSQ is the sum of these subscale domains and ranges from 0-100, where a higher value is a better outcome.
Neurocognitive function WMS
时间窗: Change from baseline at 3 and 6 months
Wechsler Memory test (WMS) will be administered to measure Verbal comprehension, and working and visual memory. Scored on a Standard scale of 100 +/- 15, where a higher score is a better outcome.
Sleep quality PSQI
时间窗: Change from baseline at 3 and 6 months
Pittsburgh Sleep Quality Index (PSQI) is a detailed assessment of subject sleep quality over the most recent month by considering seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score to assess sleep quality on a scale of "poor" to "good".
Neurocognitive function PASAT
时间窗: Change from baseline at 3 and 6 months
PASAT (Paced Auditory Serial Addition Test) will be administered to evaluate vigilance and executive function. The PASAT is recorded as the total number of correct responses (from 0-60), or the percent of correct responses out of 60 (from 0-100), where a higher value is a better outcome.
Neurocognitive function Stroop color-word interference
时间窗: Change from baseline at 3 and 6 months
Stroop color-word interference test will be administered to evaluate executive function. This score is adjusted for age, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Neurocognitive function DIGIT
时间窗: Change from baseline at 3 and 6 months
DIGIT test will be administered to evaluate short-term and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Neurocognitive function PVT
时间窗: Change from baseline at 3 and 6 months
Psychomotor Vigilance Test (PVT) will be administered to measure Alertness and vigilance, in terms of number of lapses and reaction time. The performance score ranges from 0-100, where a higher value is a better outcome.
Quality of life SF-36v2
时间窗: Change from baseline at 3 and 6 months
QoL will be assessed using the survey SF-36v2 Health survey. Thirty-five of the SF-36v2 items are used to measure eight domains of health-related quality of life. These are on a scale of 0-100, where higher values indicate a better outcome.
Quality of life SGRQ
时间窗: Change from baseline at 3 and 6 months
Disease specific QoL will be assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ has three subscale domains (Symptoms, Activity, and Impacts), which range from 0-100, where a higher value indicates a worse outcome. The total SGRQ is the average of these subscale domains and is on a scale of 0-100, where a higher value is a worse outcome.
Neurocognitive function WASI
时间窗: Change from baseline at 3 and 6 months
Abbreviated Wechsler Abbreviated Scale of Intelligence (WASI) will be administered to evaluate verbal comprehension and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Sleepiness ESS
时间窗: Change from baseline at 3 and 6 months
Epworth sleepiness scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates greater degree of sleepiness.
次要结局
- Hours of nightly positive airway pressure (PAP) use(Change from baseline at 3 and 6 months)
- Fatigue severity(Change from baseline at 3 and 6 months)
- Patient preferance for type of PAP (PAP arm)(at 3 and 6 months)
- Sleep-dependent memory(At baseline and at 3 months)
- Blood CO2 or bicarbonate level(At baseline and at 6 months)