NCT05309473招募中不适用
Slow-wave Sleep Enhancement Using Acoustic Stimulation to Facilitate Performance Recovery During Restricted Sleep After Sleep Deprivation
Walter Reed Army Institute of Research (WRAIR)2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年3月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
研究概览
简要总结
The purpose of this study is to determine if brief sounds or tones presented within a restricted period of recovery sleep after a period of sleep deprivation will enhance restorative properties and improve performance during a subsequent period of wakefulness.
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
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)
- •Must demonstrate adequate comprehension of the protocol, by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given one opportunity to retest after a review of protocol information. Individuals who fail the comprehension assessment for the second time will be disqualified.
排除标准
- •You must have learned English as your first language
- •You must have a body mass index (BMI) below 30 (this is a mathematical calculation of your height and weight)
- •You must not have current or a history of sleeping problems (for example, insomnia or sleep apnea), or symptoms that indicate a potential sleep disorder
- •You must get an average of 6-9 hours of sleep per night and maintain a normal sleep/wake schedule
- •You must not drink excessive amounts of caffeine, alcohol, or smoke cigarettes regularly
- •You must not be on certain medications (determined on a case by case basis)
- •You must test negative for illicit drugs
- •Women must not be pregnant or nursing
- •You must not be participating in another ongoing clinical trial
- •You must have a social security number or tax identification number in order to be paid for screening and participation in the study
- •You cannot have a history of the following conditions: Cardiovascular disease, a neurologic disorder, pulmonary disease requiring inhaler use, kidney disease or kidney abnormalities, liver disease of liver abnormalities, a history of psychiatric disorder requiring hospitalization or medication within the last two years or for a continuous period of more than 6 months in the last ten years
结局指标
主要结局
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
时间窗: 8 days
Performed at approximately 75 minutes intervals throughout the sleep deprivation and recovery days
次要结局
- Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)(5 days)
- Measure various aspects of Sleep and Wakefulness using Actigraphy(22 days)
- Measure alertness using the Karolinska Sleepiness Scale (KSS)(5 days)
- Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery(5 days)
- Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)(5 days)
- Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video(5 days)
- Measure current mood states using the Mood Analogue Scale (MAS)(5 days)
研究者
JOHN D. HUGHES
Neurologist
Walter Reed Army Institute of Research (WRAIR)
研究点 (2)
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