Impaired Vigilance, and Its Effects on Cognition and Behavior

Stanford University

Status: Completed

Conditions: Feeding Behavior; Sleep Deprivation

Treatments: Behavioral: Time in bed

Study type: Interventional

Funder types: Other

Identifiers

NCT02484846

IRB-20650

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 7 patient groups

60% TIB

Experimental group

Description:

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

Treatment:

Behavioral: Time in bed

70% TIB

Experimental group

Description:

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

Treatment:

Behavioral: Time in bed

80% TIB

Experimental group

Description:

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

Treatment:

Behavioral: Time in bed

90% TIB

Experimental group

Description:

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

Treatment:

Behavioral: Time in bed

100% TIB

Active Comparator group

Description:

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

Treatment:

Behavioral: Time in bed

115% TIB

Experimental group

Description:

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

Treatment:

Behavioral: Time in bed

130% TIB

Experimental group

Description:

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

Treatment:

Behavioral: Time in bed