Impaired Vigilance, and Its Effects on Cognition and Behavior

NCT ID: NCT02484846

Last Updated: 2015-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-03-31

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.

Conditions

Sleep Deprivation; Feeding Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

60% TIB

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

Group Type: EXPERIMENTAL

Time in bed

Intervention Type: BEHAVIORAL

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.

70% TIB

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

Group Type: EXPERIMENTAL

Time in bed

Intervention Type: BEHAVIORAL

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.

80% TIB

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

Group Type: EXPERIMENTAL

Time in bed

Intervention Type: BEHAVIORAL

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.

90% TIB

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

Group Type: EXPERIMENTAL

Time in bed

Intervention Type: BEHAVIORAL

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.

100% TIB

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

Group Type: ACTIVE_COMPARATOR

Time in bed

Intervention Type: BEHAVIORAL

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.

115% TIB

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

Group Type: EXPERIMENTAL

Time in bed

Intervention Type: BEHAVIORAL

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.

130% TIB

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

Group Type: EXPERIMENTAL

Time in bed

Intervention Type: BEHAVIORAL

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.

Interventions

Time in bed

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jamie M. Zeitzer, Ph.D.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 28364494 (View on PubMed)

Other Identifiers

IRB-20650

Identifier Type: -

Identifier Source: org_study_id