Neurocognition After Perturbed Sleep (NAPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- MATRICS Consensus Cognitive Battery (MCCB)
研究概览
简要总结
Individuals with schizophrenia display a wide range of neurocognitive difficulties resulting in functional impairment and disability. Extensive evidence indicates insomnia and sleep disturbances play a substantial role in degrading cognitive functioning. However, the putative impact of insomnia and sleep disturbances on neurocognition and daily functioning has not been investigated in people with schizophrenia. The goal of this study is to characterize sleep in individuals with schizophrenia and quantify its impact on neurocognition and daily functioning.
详细描述
Individuals with SZ display a broad range of neurocognitive difficulties that have been identified as major determinants of poor functioning and disability, thus representing an important public health concern and a focal target for interventions. Extensive research literatures converge in highlighting the critical role insomnia and sleep disturbances play in degrading neurocognitive functioning. Such sleep disturbances result in clinical presentations similar to neurocognitive difficulties commonly observed in people with SZ. While insomnia and sleep disturbances are highly prevalent in people with SZ, there are scant data on the impact of sleep disturbances on neurocognition in SZ, and no data quantifying their influence on daily functioning. Thus, sleep disturbances remain poorly understood and modeled in SZ, their impact is rarely considered in clinical trials, and they remain largely unaddressed by clinicians. To address this gap in knowledge, the primary aim of this study is to characterize sleep in individuals with SZ and quantify its impact on neurocognition and daily functioning. Employing an experimental, within-person, repeated assessment design, the study team will characterize sleep architecture, duration, and quality along with cognitive, electrophysiological, biomarkers and daily functioning sequelae in 40 individuals with SZ. Participants will first complete a week-long, in-home characterization of sleep duration and quality using actigraphy and a sleep diary. Next, they will complete two overnight polysomnography examinations employing two sleep schedules:
- undisturbed sleep; and 2) restricted sleep (4 hours). As part of these assessments, participants will provide blood samples for biomarkers analyses and complete EEG-indexed memory tasks pre- and post-sleep, along with a post-sleep battery of neurocognitive functioning.
Finally, participants will complete a 3-day ambulatory assessment using actigraphy and smartphones to explore the impact of each sleep schedule on "real-world" daily functioning including symptoms, emotion regulation, and mood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
The neurocognitive evaluators who administer the neurocognitive battery (MCCB) will be blinded to sleep schedule.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females or males age 18-60 years
- •DSM-5 diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder
- •Taking antipsychotic medication for >7 weeks and on current doses for 4 weeks, and/or injectable depot antipsychotics with no change in the last 3 months
- •Capacity to understand all the potential risks and benefits of the study.
排除标准
- •DSM-5 alcohol/substance diagnosis (except nicotine) within the last 6 months
- •Taking medications affecting sleep propensity or architecture (other than antipsychotic medication)
- •Initiation of medications known to impact cognition in previous 4 weeks or any change in doses during this period
- •History of seizures/head trauma with loss of consciousness (>10 min) resulting in cognitive sequelae
- •Medical or neurological conditions that could interfere with participation (e.g., untreated hypothyroidism
- •Mental retardation
- •Narcolepsy
- •REM behavior disorder, parasomnias)
- •Pregnant/ nursing
- •Serious homicidal/suicidal risk (past 6 months)
- •Moderate or more severe disorganization (PANSS≥4)
- •Poor English reading ability (WTAR<7)
- •Individuals employed as vehicle drivers/train operators or have occupations in which lapses in sustained vigilance would compromise safety
- •Night shift workers or those with irregular sleep-wake rhythms (based on the week-long home actigraphy; i.e., average bedtime of 11pm±2 hours)
- •Participation in the past 3 months in cognition study
结局指标
主要结局
MATRICS Consensus Cognitive Battery (MCCB)
时间窗: Day 16, immediate upon wakening
The composite score of the MATRICS Consensus Cognitive Battery (MCCB) will serve as a primary neurocognitive outcome. Neurocognitive functioning is indexed on the MCCB via T scores, with a mean of 50 and a SD of 10. Thus, higher scores indicate better neurocognitive performance, with T-scores of 70+ (i.e., 2 SD's over the mean) suggestive of exceptionally strong neurocognitive abilities.
Polysomnography
时间窗: Days 15-16 during restricted sleep and undisturbed sleep
Polysomnography will be used to characterize sleep including - latency, duration, continuity, and architecture assessed during over a night sleep.
次要结局
未报告次要终点
研究者
David Kimhy
Associate Professor
Icahn School of Medicine at Mount Sinai