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Completed

NCT Number: NCT02484846

Impaired Vigilance, and Its Effects on Cognition and Behavior

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time in bed

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.

Primary outcomes

  1. Total calories consumed

    Time frame: 45 minutes

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

Secondary outcomes

  1. Alertness

    Time frame: 15 minutes

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2015
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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