Impaired Vigilance, and Its Effects on Cognition and Behavior

Sleep Deprivation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484846
• Other study ID #: IRB-20650
• Status: Completed
• Phase: N/A
• First received: June 24, 2015
• Last updated: June 29, 2015
• Start date: February 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2015
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Feeding Behavior
• Sleep Deprivation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total calories consumed	Total calories consumed during a 45 minute meal opportunity during the each of the two study sessions.	45 minutes	No
Secondary	Alertness	Objective alertness was determined during each of the two study sessions during a 15 minute test of sustained attention (Psychomotor Vigilance Task).	15 minutes	No