SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Continuous Performance Test (CPT)
研究概览
简要总结
The objective of this study is to compare the efficacy of a sleep intervention on improving cognitive function in older adults with symptoms of insomnia, determine the association between change in sleep measures and change in cognitive function, and examine the efficacy of the sleep intervention on reducing the rate of Aβ deposition. Participants, ages 60-85, will be randomly assigned to a six-week sleep intervention program. A sub-group of fifty participants will undergo Florbetapir-Positron-emission tomography (PET) imaging during the one-year reassessment to examine the efficacy of the sleep intervention on reducing the rate of Aβ accumulation from baseline to one-year post-intervention.
详细描述
Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease (AD). However, despite the strong links between sleep disruptions, cognitive decline, and AD, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent AD. Approximately fifteen percent of AD may be prevented by an efficacious intervention aimed to reduce sleep disturbances and sleep disorders. Chronic insomnia is the most frequent sleep disorder occurring in at least forty percent of older adults. Individuals with insomnia are more likely to be diagnosed with AD and demonstrate a decline in cognitive function at long-term follow-up. AD is characterized by the accumulation of Aβ plaques and tau tangles in the brain, and growing evidence shows impaired sleep contributes to the accumulation of Aβ. An intervention aimed at improving insomnia may represent a critical opportunity for primary prevention to slow cognitive decline and potentially delay the onset of AD. Therefore, the long-term goal of this research agenda is to understand how addressing sleep disturbances, via sleep intervention, may delay the onset of AD.
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 (Care Provider)
盲法说明
The research assistant will be blinded to the participant's intervention group.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Report of difficulty falling asleep, maintaining sleep, or waking up too early at least three nights a week for the past six months
- •A score of greater than, or equal to, ten on the Insomnia Severity Index
- •A score of greater than, or equal to, twenty-five on the Mini-Mental State Examination (MMSE)
- •A score of less than, or equal to, two on the Dementia Screening Interview (AD8)
排除标准
- •A known untreated sleep disorder (i.e., sleep apnea or restless leg syndrome)
- •Currently taking benzodiazepines, non-benzodiazepines, melatonin supplements, or agonists for insomnia
- •A score of greater than, or equal to, fifteen on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of any suicidal ideation (an answer of one, two, or three on item number nine of the PHQ-9)
- •History of drug or alcohol abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-4) criteria within the last two years
- •History of a nervous system disorder (i.e., stroke, Parkinson's Disease)
- •Severe mental illness (i.e., Schizophrenia, Bipolar Disorder)
- •History of a learning disability or attention-deficit/hyperactivity disorder
- •Current, or history of, shift work
- •Currently receiving CBT-I treatment
- •Unable to hear at a conversational level
- •Failure of a near vision test utilizing the Logarithmic Near Visual Acuity Chart
研究组 & 干预措施
Six-Week CBT-I Program
CBT-I, six sessions, forty-five to sixty minutes in duration.
Session 1: set up sleep restriction and stimulus control, discuss strategies for how to stay awake to a prescribed hour and what to do with wake after onset sleep time, provide sleep hygiene education.
Session 2: determine if upward titration of total sleep time is warranted, review sleep hygiene.
Session 3: continue upward titration of total sleep time, cognitive therapy for negative sleep beliefs if indicated.
Session 4: continue upward titration of total sleep time, follow-up regarding negative sleep beliefs.
Session 5: continue upward titration of total sleep time, discuss relapse prevention.
Session 6: assess global treatment gains, discuss questions regarding relapse prevention.
干预措施: Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
Six-Week Sleep and Lifestyle Education Program
Sleep and Lifestyle Education, six sessions, forty-five to sixty minutes in duration.
Session 1: Sleep education, Instruction/demonstration on stretching exercises.
Session 2: Education on environmental factors & sleeping positions that impact sleep.
Session 3: Education on lifestyle factors that impact sleep.
Session 4: Education on diet and sleep.
Session 5: Education on exercises and sleep.
Session 6: Discus maintaining achievements & preventing relapses.
干预措施: Sleep and Lifestyle Education (Behavioral)
结局指标
主要结局
Continuous Performance Test (CPT)
时间窗: 6-Week Reassessment
Assessment of the participants attention. Participants will be given a set of rules for stimuli, and based on those rules they will determine if a presented stimuli fit within those rules. Scores will be determined by the number of correctly identified stimuli. Hit Reaction Time (HRT) is reported as a T-score (M = 50, SD = 10), where higher scores indicate slower reaction time and worse performance.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: 6-Week Reassessment
Cognitive function will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS consists of 12 subtests assessing immediate memory, visuospatial/constructional abilities, language, attention, and delayed memory. The RBANS Total Scale Score is reported as a Standard Score with a normative mean of 100 and standard deviation of 15. Possible scores range from 40 to 160. Higher scores indicate better overall cognitive performance.
Stroop Test
时间窗: 6-Week Reassessment
Assessment of participants executive functioning. Participants will be required to inhibit their natural response and replace it with a different response (i.e., reading a word versus saying the color of the word). Scores are obtained by taking the difference between conditions and normalizing for the number of stimuli. Stroop Interference outcomes were reported as T-scores (M = 50, SD = 10), with higher scores reflecting greater interference and worse executive function.
Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test
时间窗: 6-Week Reassessment
Participants are asked to recall strings of numbers in order (Forward) and in reverse order (Backward). The outcome is the longest string of numbers correctly recalled in each direction. Scores are reported as Standard Scores (M = 10, SD = 3), with possible scores ranging from 1 to 19. Higher scores indicate better auditory attention, immediate memory (Forward), and working memory/executive function (Backward).
次要结局
- Polysomnography(6-Week Reassessment)