Phenotypic and Genotypic Markers of Performance Vulnerability to Sleep Loss

December 1, 2015 updated by: University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Unit for Experimental Psychiatry, Sleep and Chronobiology Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A total of N=110 adult subjects (aged 21-50 yr), N=55 females and N=55 males of all ethnicities, will be randomized to the 2 different experimental conditions. Subjects must also be comparable in terms of their homeostatic and circadian sleep-wake regulation parameters. In order to be eligible to participate, subjects must meet the following 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PSD then TSD
baseline sleep, five nights sleep restriction, four nights recovery sleep, one night total sleep deprivation, one night recovery sleep
Behavioral: Sleep
Experimental: TSD then PSD
baseline sleep, one night total sleep deprivation, four nights recovery sleep, five nights sleep restriction, one night recovery sleep
Behavioral: Sleep

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psychomotor Vigilance Test
Time Frame: Completed every two hours during waking hours during each day of the study (14 days total) which includes days following baseline sleep, sleep restriction or sleep deprivation and recovery sleep
3, 10, or 20 minute simple, high-signal-load reaction time (RT)-based test invented by our group and designed to evaluate the ability to sustain attention and respond in a timely manner to salient signals
Completed every two hours during waking hours during each day of the study (14 days total) which includes days following baseline sleep, sleep restriction or sleep deprivation and recovery sleep

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Namni Goel, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 812523

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Dietary Supplements

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Locations

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