Cognitive Benefits of Treating Sleep Apnea in Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Tests to Determine the Apnea-hypopnea Index (Number of Apneas and Hypopneas Per Hour of Sleep)
研究概览
简要总结
Patients with sleep disordered breathing (SDB), also called sleep apnea, experience nighttime disrupted sleep and, because they stop breathing for short periods during the night, do not get sufficient oxygen to their brains. This can frequently result in daytime impairments including difficulties with memory. The state-of-the-art treatment for SDB is Continuous Positive Airway Pressure (CPAP). Many non-demented SDB patients who are successfully treated with CPAP show improvement in memory and other cognitive functions. Data have shown that patients with Parkinson's disease have a high rate of SDB. Patients with Parkinson's disease also often have problems with memory. This study will test the effects of treating SDB among patients with Parkinson's disease and SDB. Specifically, the study will test the effect of CPAP treatment on SDB and sleep; the effect of CPAP treatment on daytime sleepiness, cognition, overall quality of life and mood; the effect of CPAP treatment on the frequency of symptoms of REM behavior disorder and restless legs syndrome; the effect of continued CPAP use (beyond the six weeks of the study) on SDB, sleep, cognition, mood and quality of life; whether the study-partner feels that CPAP improves the patient's sleep, mood and overall functioning; whether study-partners feel that their own sleep, mood and overall functioning improve as the patient's sleep improves both during the 6-week protocol and at follow-up for those opting to continue using CPAP.
详细描述
This study will examine the effect of three weeks vs. six weeks of CPAP treatment on cognitive functioning and sleep in patients with Parkinson's disease and sleep apnea. It is designed as a randomized, double blind, placebo-controlled trial of CPAP. As a comparison group, half the patients will first be randomly assigned to three weeks of shamCPAP, followed by three weeks of therapeutic CPAP treatment. Sleep, functional outcome and mood questionnaires and a repeatable neuropsychological test battery, chosen to be sensitive to the type of changes we expect to find in memory and cognitive function, will be administered before the start of treatment, after three weeks, and after six weeks of treatment.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of dementia due to Parkinson's disease (according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (code 294.1)
- •MMSE score between 18 and 26, inclusive; cognitive symptoms must occur at least one year after the diagnosis of PDD
- •Apnea hypopnea index >10 (i.e., 10 apneas plus hypopneas per hour of sleep)
- •Over the age of 50 years
- •Stable health
- •Fluent English speaking
- •Patients will be allowed to continue dopaminergic medications, acetylcholinesterase inhibitors, psychotropic medications, memory enhancers, health food supplements, etc. as long as they have been stable on the same dose for at least two months prior to participation and agree to continue on this dose for the duration of the 6-week study.
排除标准
- •Current treatment for sleep apnea (to avoid discontinuing already established treatment for sleep apnea and any carry over confounding effect of treatment on cognition).
- •Central sleep apnea
- •Use of medications known to influence sleep (i.e. sedative hypnotics, narcotics) if the dose cannot remain stable for the duration of the study.
- •Bronchospastic and symptomatic chronic obstructive pulmonary disease as indicated by regular use of bronchodilators, steroids, history of carbon dioxide retention, waking hypoxemia (PaO2 <60 mmHg or SpO2 <92 % by pulse oximetry), or use of supplemental oxygen.
- •Symptomatic coronary or cerebral vascular disease (history of myocardial infarction, angina, stroke, or transient ischemic attacks), history of life-threatening arrhythmias, cardiomyopathy, or current alcohol or drug abuse
- •Current diagnosis of active seizure disorder; presence of any neurodegenerative disorder other than PDD or other causes of dementia
- •Any behavioral or physical problem that would preclude completion of the primary evaluation or treatment with CPAP.
研究组 & 干预措施
therapeutic CPAP Treatment (6 weeks)"
Intervention - The active comparator is an intervention of nightly therapeutic CPAP (continuous positive airway pressure) treatment for 6 weeks. Patients will use CPAP every night for the full duration of the study, i.e., 6 weeks
干预措施: Continuous positive airway pressure (CPAP) (Device)
Sham CPAP/therapetuic CPAP (6 weeks)"
The placebo comparator is an intervention of placebo CPAP (continuous positive airway pressure) nightly for 3 weeks followed by therapeutic CPAP treatment nightly for 3 weeks.
Patients will use a sham CPAP (no real pressure) for 3 weeks and then will be switched to real CPAP for 3 weeks.
干预措施: Placebo CPAP (Device)
结局指标
主要结局
Tests to Determine the Apnea-hypopnea Index (Number of Apneas and Hypopneas Per Hour of Sleep)
时间窗: six weeks
Overnight sleep studies were done to determine the effect of treatment on the apnea-hypopnea index (number of apneas and hypopneas per hour of sleep)
次要结局
- Sleep Stages; %Time Spent at SaO2<90%;(6 weeks)
研究者
Sonia Ancoli-Israel
Professor
University of California, San Diego