Impaired Vigilance, and Its Effects on Cognition and Behavior

Not Applicable

Completed

• Conditions: Sleep Deprivation; Feeding Behavior
• Interventions: Behavioral: Time in bed

• Registration Number: NCT02484846
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2015-06
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-29
• Last Update Submitted: 2015-06-29
• Study First Posted: 2015-06-30
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100% TIB	Time in bed	Participants were to spend 100% of their normal time in bed (i.e., no change) on the night prior to the second visit.
70% TIB	Time in bed	Participants were to spend 70% of their normal time in bed on the night prior to the second visit.
90% TIB	Time in bed	Participants were to spend 90% of their normal time in bed on the night prior to the second visit.
115% TIB	Time in bed	Participants were to spend 115% of their normal time in bed on the night prior to the second visit.
130% TIB	Time in bed	Participants were to spend 130% of their normal time in bed on the night prior to the second visit.
80% TIB	Time in bed	Participants were to spend 80% of their normal time in bed on the night prior to the second visit.
60% TIB	Time in bed	Participants were to spend 60% of their normal time in bed on the night prior to the second visit.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Alertness	15 minutes	Objective alertness was determined during each of the two study sessions during a 15 minute test of sustained attention (Psychomotor Vigilance Task).