Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
Cognitive dysfunction in the aging Veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance cognitive impairment in the elderly Veteran population. Thus, the investigators will study whether elderly patients with Overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with positive airway pressure (PAP) and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly Veterans.
详细描述
OBJECTIVE: Describe the clinical and physiological characteristics of obstructive sleep apnea (OSA) and comorbid chronic obstructive pulmonary disease (COPD) and study the impact of treatment on neurocognitive outcomes in elderly Veterans.
RESEARCH PLAN: The investigators will study if elderly Veterans with OSA and comorbid COPD have increased neurocognitive deficits and sleepiness with reduced quality of life compared to patients with either OSA or COPD alone (Aim 3) and whether treatment with PAP/NIPPV and supplemental oxygen compared to CPAP alone in elderly Veterans with moderate-to-severe OSA and concomitant moderate-to-severe COPD will improve cognitive function, sleepiness and quality of life (QoL).
Aim A: To determine if elderly Veterans with OSA and comorbid COPD have increased neurocognitive deficits and sleepiness compared to patients with either OSA or COPD.
Hypothesis: Elderly veterans (age 60 years) with moderate-to-severe OSA and concomitant moderate-to-severe COPD will have significantly increased cognitive deficits and daytime sleepiness compared with similar patients with OSA alone or COPD alone.
To study this aim the investigators will prospectively administer and compare the results of a battery of cognitive tests, and sleepiness and QoL questionnaires in elderly patients with OSA, COPD, and the Overlap Syndrome.
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
- None
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OSA defined by the International classification of Sleep Disorders-322 diagnostic criteria with moderate-to-severe disease, i.e. apnea hypopnea index (AHI) 15* per hour by polysomnography
- •Moderate-to-severe COPD defined by GOLD 2 and 3 (Global Obstructive Lung Disease) 23 criteria with FEV1/FVC ratio <70% and FEV1 >30% and <80% of predicted based on PFT done within the past 1 year and a past significant history (10 pack-years) of smoking
- •Age 60 years
- •Male or female gender
排除标准
- •Mild COPD
- •Overlap Syndrome with mild OSA plus mild COPD
- •Central sleep apnea defined as central apnea index >5 per hour
- •Already on daytime oxygen or nighttime CPAP, NIPPV, oral appliance
- •Current smokers
- •Pregnant women
- •Disorders of hypoventilation due to known neuromuscular or chest wall diseases**
- •Patients with significant restrictive lung disease on pulmonary function testing
- •Recent admission for any acute illness within the prior 4 months
- •Current psychiatric illness requiring sedating medications
- •Use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect alertness or daytime functioning for Aim 3/4
- •For Aim 3 and 4 only, existing depression as assessed by the PHQ (Patient Health Questionnaire)-9 (score >10)
- •History of learning disability
- •Inability to sign consent
- •Epworth sleepiness score 18 or a near-miss or prior automobile accident due to sleepiness within the past 12 months
- •Patients with unstable heart disease, decompensated heart failure, ejection fraction<45% or uncontrolled arrhythmias
- •Patients unable to use either a nasal or face mask (e.g., facial trauma)
- •Consumption of > 2 alcoholic beverages per day or past history of excessive alcohol use
- •Current use of illicit drugs
- •Patients who have problems with vision or dexterity and hence, cannot use CPAP/NIPPV
- •Life expectancy is less than 6 months
研究组 & 干预措施
Positive airway pressure therapy
Control group patients will receive standard care with PAP- positive airway pressure.
干预措施: Positive airway pressure (Device)
Positive airway pressure therapy
Control group patients will receive standard care with PAP- positive airway pressure.
干预措施: NIPPV and /or oxygen (Device)
COPD
The COPD control group will be patients with moderate-to-severe COPD alone per the GOLD criteria.
OSA and comorbid COPD
Eligible elderly (age >/=60yrs) Veterans with moderate to severe Overlap Syndrome.
结局指标
主要结局
Quality of life
时间窗: Change from baseline quality of life at 3 months
Quality of Life (Qol) Questionnaires: QoL will be assessed using the Short-Form survey (SF-12). There are two subscale domain scores (Physical Health Composite Score-PCS and Mental Health Composite Score-MCS). These are on a scale of 0-100, where higher values indicate a better outcome.
Neurocognitive function
时间窗: Change from baseline neurocognitive function at 3 months
The neurocognitive test - Trails A 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 test
时间窗: Change from baseline at 3 months
The neurocognitive test - 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.
Sleepiness
时间窗: Change from baseline sleepiness at 3 months
Epworth Sleepiness Scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates a worse outcome.
次要结局
- Hours of nightly positive airway pressure (PAP) use/NIPPV use(90 days after start of therapy)
- Hours of nightly oxygen use(3 months after start of therapy)
- Blood pressure(At baseline)
- Borg scale(Change from baseline at 3 months)
- Dyspnea(Change from baseline at 3 months)