Phenotypic and Genotypic Markers of Performance Vulnerability to Sleep Loss

NCT ID: NCT02130791

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-11-30

Brief Summary

Insufficient sleep is common, affecting 20-40% of adults, and resulting from sleep disorders, medical conditions, work demands, stress/emotional distress, and social/domestic responsibilities. It produces significant social, financial and health-related costs, and it has increasingly become a major public health concern as population studies worldwide have found that reduced sleep duration is associated with increased risks of obesity, morbidity, and mortality. It is well established that sleep loss causes fatigue and sleepiness, as well as errors and accidents that are due to its adverse neurobehavioral effects on alertness, mood, and cognitive functions. However, there are substantial, trait-like differences among people in the extent to which they experience such neurobehavioral deficits when sleep deprived. Common genetic variations involved in sleep-wake, circadian, and cognitive regulation may underlie these large inter-individual differences in neurobehavioral vulnerability to sleep deprivation, though it remains unclear whether different types of sleep deprivation involve the same phenotypic responses and same genotypic contributors. This project will be the first large-scale investigation of markers of differential cognitive vulnerability to both acute total sleep loss and chronic partial sleep loss. It will identify individuals who are at significant risk for fatigue and severe impairments from sleep loss. A total of 110 healthy adults will undergo a 13-day laboratory protocol to thoroughly characterize their cognitive, psychological and physiological responses to two of the most common forms of sleep loss--acute total sleep deprivation (1 night of sleep loss) and chronic partial sleep deprivation (5 nights of sleep limited to 4 hr). The findings from this study will represent a critical first step toward tailoring appropriate follow-up interventions for sleep loss and its symptomatic relief by finding predictors of at-risk individuals who should avoid sleep loss whenever possible, and/or seek effective countermeasures. Whether or not markers of neurobehavioral vulnerability to sleep loss are identified, the results of the project will help inform public policies pertaining to the need for adequate sleep and for countermeasures for sleep loss, and also will further our understanding and management of vulnerability to excessive sleepiness due to common sleep and medical disorders.

Conditions

Sleep Restriction Then Total Sleep Deprivation; Total Sleep Deprivation Then Sleep Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

PSD then TSD

baseline sleep, five nights sleep restriction, four nights recovery sleep, one night total sleep deprivation, one night recovery sleep

Group Type: EXPERIMENTAL

Sleep

Intervention Type: BEHAVIORAL

TSD then PSD

baseline sleep, one night total sleep deprivation, four nights recovery sleep, five nights sleep restriction, one night recovery sleep

Group Type: EXPERIMENTAL

Sleep

Intervention Type: BEHAVIORAL

Interventions

Sleep

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age between 21 and 50 years (average age of our current protocols is 31 years)

2. Body mass index (BMI) within 20.5% of normal

3. Stable, normally-timed sleep-wake cycle as determined by interview, 2-week daily sleep log, and 2-week wrist actigraphic evidence, and defined by:

4. Habitual nocturnal sleep duration between 6.5h and 8.5h

5. Habitual morning awakening between 0600h and 0930h

Exclusion Criteria

• 1. No evidence of habitual napping 2. No shift work, transmeridian travel or irregular sleep/wake routine in the past 60 days 3. No sleep disorder, determined by history, actigraph, pulse oximetry and PSG 4. No history of mania or psychosis 5. No current depression as determined by the Beck Depression Inventory 6. No alcohol or drug abuse in the past year based upon history and urine toxicology screen

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Namni Goel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Unit for Experimental Psychiatry, Sleep and Chronobiology Laboratory

Philadelphia, Pennsylvania, United States

Countries

United States

References

Spaeth AM, Dinges DF, Goel N. Objective Measurements of Energy Balance Are Associated With Sleep Architecture in Healthy Adults. Sleep. 2017 Jan 1;40(1):zsw018. doi: 10.1093/sleep/zsw018.

Reference Type: DERIVED

PMID: 28364451 (View on PubMed)

Spaeth AM, Dinges DF, Goel N. Sex and race differences in caloric intake during sleep restriction in healthy adults. Am J Clin Nutr. 2014 Aug;100(2):559-66. doi: 10.3945/ajcn.114.086579. Epub 2014 Jun 25.

Reference Type: DERIVED

PMID: 24965304 (View on PubMed)

Other Identifiers

812523

Identifier Type: -

Identifier Source: org_study_id