Back to resultsImpaired Vigilance, and Its Effects on Cognition and Behavior
Primary Purpose
Sleep Deprivation, Feeding Behavior
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Time in bed
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Deprivation
Eligibility Criteria
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
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Arm Label
60% TIB
70% TIB
80% TIB
90% TIB
100% TIB
115% TIB
130% TIB
Arm Description
Participants were to spend 60% of their normal time in bed on the night prior to the second visit.
Participants were to spend 70% of their normal time in bed on the night prior to the second visit.
Participants were to spend 80% of their normal time in bed on the night prior to the second visit.
Participants were to spend 90% of their normal time in bed on the night prior to the second visit.
Participants were to spend 100% of their normal time in bed (i.e., no change) on the night prior to the second visit.
Participants were to spend 115% of their normal time in bed on the night prior to the second visit.
Participants were to spend 130% of their normal time in bed on the night prior to the second visit.
Outcomes
Primary Outcome Measures
Total calories consumed
Total calories consumed during a 45 minute meal opportunity during the each of the two study sessions.
Secondary Outcome Measures
Alertness
Objective alertness was determined during each of the two study sessions during a 15 minute test of sustained attention (Psychomotor Vigilance Task).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02484846
Brief Title
Impaired Vigilance, and Its Effects on Cognition and Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Feeding Behavior
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
60% TIB
Arm Type
Experimental
Arm Description
Participants were to spend 60% of their normal time in bed on the night prior to the second visit.
Arm Title
70% TIB
Arm Type
Experimental
Arm Description
Participants were to spend 70% of their normal time in bed on the night prior to the second visit.
Arm Title
80% TIB
Arm Type
Experimental
Arm Description
Participants were to spend 80% of their normal time in bed on the night prior to the second visit.
Arm Title
90% TIB
Arm Type
Experimental
Arm Description
Participants were to spend 90% of their normal time in bed on the night prior to the second visit.
Arm Title
100% TIB
Arm Type
Active Comparator
Arm Description
Participants were to spend 100% of their normal time in bed (i.e., no change) on the night prior to the second visit.
Arm Title
115% TIB
Arm Type
Experimental
Arm Description
Participants were to spend 115% of their normal time in bed on the night prior to the second visit.
Arm Title
130% TIB
Arm Type
Experimental
Arm Description
Participants were to spend 130% of their normal time in bed on the night prior to the second visit.
Intervention Type
Behavioral
Intervention Name(s)
Time in bed
Intervention Description
Habitual time spent in bed for the purpose of sleep was determined at baseline. This was used to calculated the experimental time in bed the subject was to spent on the one night prior to the second lab visit.
Primary Outcome Measure Information:
Title
Total calories consumed
Description
Total calories consumed during a 45 minute meal opportunity during the each of the two study sessions.
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Alertness
Description
Objective alertness was determined during each of the two study sessions during a 15 minute test of sustained attention (Psychomotor Vigilance Task).
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
28364494
Citation
Pardi D, Buman M, Black J, Lammers GJ, Zeitzer JM. Eating Decisions Based on Alertness Levels After a Single Night of Sleep Manipulation: A Randomized Clinical Trial. Sleep. 2017 Feb 1;40(2). doi: 10.1093/sleep/zsw039.
Results Reference
derived
Learn more about this trial
Impaired Vigilance, and Its Effects on Cognition and Behavior
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