The Impact of Alzheimer's Disease on Sleep in Adults With Down Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Sleep Efficiency
研究概览
简要总结
RATIONALE of the project. Adults with Down syndrome (DS) present severe sleep disorders that are under recognized by caregivers. Aging in DS population increases the prevalence of both Obstructive Sleep Apnea (OSA) and Alzheimer´s disease (AD) dementia at much higher rates than in the general population. AD increases the risk of sleep disturbances and OSA, which in turn worsen cognitive performance and behavioral function.
Our hypothesis is that adults with DS and AD dementia will present a higher prevalence of sleep disorders (sleep disruption, sleep circadian disorders and OSA) than in DS without dementia.
There are no data evaluating nocturnal sleep in adults with DS with AD dementia.
The main objective is to evaluate the prevalence of sleep disturbances in adult subjects with DS and AD dementia, by means of subjective and objectives sleep measures.
详细描述
Aims To characterize and determine the prevalence of sleep disorders and sleep wake pattern in a large community-based sample of adult subjects with DS and AD dementia and to correlate the results with clinical, cognitive and behavioral features.
OBJECTIVES:
The general objective is to evaluate the impact of AD dementia on sleep in adults with DS.
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By evaluating the frequency of sleep problems in demented adults with DS through:
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Nocturnal sleep by polysomnography (PSG)
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Subjective sleep quality (Pittsburg) and daytime Somnolence (Epworth)
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Sleep-wake pattern by actimetry
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By analyzing the association between sleep problems and both age and body mass index (BMI)
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By analyzing the impact of sleep problems on:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes with ages over 18 years old with DS.
- •Subjects will have to be able to understand and accept the study procedures and sign an informed consent (patient and or guardian).
- •Only subjects with mild and moderate mental retardation according to ICD-10criteria (IQ scores> 34).
- •Subjects with dementia: subjects with acquired cognitive impairment (assessed by longitudinal neuropsychological tests and/or anamnesis to the family). Absence of comorbid psychiatric disorders (major depressive disorder, bipolar disorder, schizophrenia, autism or behavioral disorders).
排除标准
- •Don't meet Inclusion Criteria
- •Severe mental retardation
- •History of conditions that could affect brain structure or function, such as stroke or traumatic brain injury
- •Patients in treatment with CPAP
- •New psychoactive drugs in the last three months preceding the survey.
结局指标
主要结局
Sleep Efficiency
时间窗: 4 weeks
The ratio of total sleep time (TST) to time in bed (TIB)
次要结局
- The apnea/hypopnea index (AHI)(4 weeks)