Effects of Sleep Deprivation and Recovery on Cognitive Functions
|ClinicalTrials.gov Identifier: NCT00179322|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 20, 2018
|First Submitted Date||September 15, 2005|
|First Posted Date||September 15, 2005|
|Last Update Posted Date||April 20, 2018|
|Study Start Date||September 10, 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00179322 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Effects of Sleep Deprivation and Recovery on Cognitive Functions|
|Official Title||Effects of Sleep Deprivation and Recovery Sleep on Speech, Language and Other Higher Cognitive Functions: A Combined EEG-fMRI Study|
This study will measure brain activity in individuals performing language tasks while in various states of alertness to learn more about how the central nervous system is affected by impairments such as sleepiness.
Healthy normal volunteers between 20 and 40 years of age may be eligible for this study. Candidates must be non-smokers, right-handed, speak English fluently and have at least 12 years of education. They are screened with a medical history, physical examination, hearing and speech evaluation, computer task training, blood and urine tests and a late-night functional magnetic resonance imaging (fMRI) scan (see description below). Before screening and again before participating in the study, candidates wear an actigraph (a wristwatch-like device that records motion) for 7 days to provide a measure of their sleep-wake patterns.
Participants undergo the following tests and procedures:
|Detailed Description||Objectives of this protocol are to examine fMRI data taken concurrently with speech, language, and decision making tasks under conditions of both alertness and sleep deprivation, comparing fMRI-defined neural activation across states and behavioral performance, assessing changes in brain function with sleep deprivation. An additional objective is to develop an fMRI signal based sleep scoring system. Subjects will be 45 normal healthy volunteers, age 20-40, who meet criteria both for safe participation in an fMRI environment and for suitability for research on normal human sleep. To examine speech and language processing and also to examine depth of sleep, we will use a within-subjects free behavior design in which we search for patterns in the arterial spin labeled (ASL) or the blood oxygen dependent (BOLD) signal in fMRI data recorded while subjects say rehearsed word sets, describe or listen to novel procedures, or transition from wake to sleep. To gauge subjects' speech and language, we will record, concurrently with fMRI, their voice for analysis in conditions of both alertness and sleep deprivation. To examine decision making, we will compare the fMRI signal during response execution and inhibition across conditions of alertness and sleep deprivation. To gauge subjects' depth of sleep during fMRI, we will use both physiological (e.g., EEG) and behavioral measures (e.g., latency and quality of rehearsed verbal response to external stimuli presented during sleep). For speech, language processing, and depth of sleep, key measures will include fundamental frequency, speaking rate, voice onset, word production, and linguistic variables (phonological, syntactic, and pragmatic) derived from recorded transcripts. For decision making, the key measure will be subjects' errors and latencies in responding to cues to make or refrain from making a prescribed action. The fMRI data corresponding to these behavioral data are expected to show systematic changes in neural activation patterns that parallel behavioral changes with sleep deprivation.|
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||September 30, 2016|
|Primary Completion Date||Not Provided|
Normal healthy volunteers in this protocol should be fluent English speaking and have at least 12 years of education.
Subjects should also be right-handed.
People who are not native speakers of English or are left handed will be excluded from this study.
Given the nature of the stimuli presentation (i.e., projected visual images and speakers carrying voice), anyone with noncorrectable vision impairments, hearing loss, or known risk for hearing loss will be excluded. Normal hearing is defined as hearing thresholds of 25dB HL or less for the octave frequencies 250 - 8000 Hz and intact crossed acoustic reflex in both ears.
The dual focus of this research on sleep deprivation and fMRI yields additional sets of exclusion criteria for both fMRI safety and normal sleep/wake patterns. Given the dimensions of the fMRI and the exam table, anyone whose body size or shape cannot be accommodated in the fMRI with a projected image remaining continuously visible will be excluded.
Women who are pregnant will be excluded from this protocol.
|Ages||20 Years to 40 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||050238
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) )|
|Study Sponsor||National Institute on Deafness and Other Communication Disorders (NIDCD)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 30, 2016|