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临床试验/NCT02484846
NCT02484846已完成不适用

Impaired Vigilance, and Its Effects on Cognition and Behavior

Stanford University0 个研究点目标入组 50 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Total calories consumed

研究概览

简要总结

Fifty healthy, young participants (10 male, 40 female) completed two 3-hour study sessions that were at least five days apart. The first session was a baseline. The sleep intervention took place on the night prior to Session 2, where the amount of time in bed was manipulated to be 60-130% of the individual's habitual sleep time. Within both sessions, subjective (Stanford Sleepiness Scale, SSS) and objective (Psychomotor Vigilance Test, PVT) alertness were measured. During the middle of each session, a 40-minute ad libitum meal opportunity allowed participants to eat from eight different food items. Food healthfulness, caloric density, distribution and number of calories were measured and compared to alertness levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age: 18-45 years
  • •BMI: 20-29 kg/m²
  • •Eat breakfast at least 5 days per week
  • •Wake time occurs between 5&10AM at least 5 days per week
  • •Time in bed for sleep between 5&10 hours at least 5 days per week

排除标准

  • •Dietary restrictions that prohibit them from selecting one of the food choices offered in the study (e.g., gluten allergies, diabetes, vegan diet, dairy avoidance, allergies to the respective food choices available),
  • •are currently on a calorie-restricted diet, or
  • •are currently at a weight that is less than 20% of their highest weight within the last three years.
  • •Participation in shift work within 7 nights of the experiment
  • •Diagnosed as having severe sleep apnea syndrome, narcolepsy or chronic insomnia
  • •Diagnosed as having an eating disorder
  • •Active serious health condition
  • •Regularly taking vigilance-related medication (e.g., ADHD prescribed medication)
  • •Typically consume more than 600 mg of coffee or more than 10 cigarettes per day

研究组 & 干预措施

60% TIB

Experimental

Participants were to spend 60% of their normal time in bed on the night prior to the second visit.

干预措施: Time in bed (Behavioral)

70% TIB

Experimental

Participants were to spend 70% of their normal time in bed on the night prior to the second visit.

干预措施: Time in bed (Behavioral)

80% TIB

Experimental

Participants were to spend 80% of their normal time in bed on the night prior to the second visit.

干预措施: Time in bed (Behavioral)

90% TIB

Experimental

Participants were to spend 90% of their normal time in bed on the night prior to the second visit.

干预措施: Time in bed (Behavioral)

100% TIB

Active Comparator

Participants were to spend 100% of their normal time in bed (i.e., no change) on the night prior to the second visit.

干预措施: Time in bed (Behavioral)

115% TIB

Experimental

Participants were to spend 115% of their normal time in bed on the night prior to the second visit.

干预措施: Time in bed (Behavioral)

130% TIB

Experimental

Participants were to spend 130% of their normal time in bed on the night prior to the second visit.

干预措施: Time in bed (Behavioral)

结局指标

主要结局

Total calories consumed

时间窗: 45 minutes

Total calories consumed during a 45 minute meal opportunity during the each of the two study sessions.

次要结局

  • Alertness(15 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie M. Zeitzer, Ph.D.

Assistant Professor

Stanford University

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