Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179322
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2005-09-15
Brief Title:
Effects of Sleep Deprivation and Recovery on Cognitive Functions
Sponsor:
National Institute on Deafness and Other Communication Disorders NIDCD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Sleep Deprivation and Recovery Sleep on Speech Language and Other Higher Cognitive Functions A Combined EEG-fMRI Study
Status:
COMPLETED
Status Verified Date:
2016-09-30
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Extended wakefulness Subjects are kept awake longer than is normal for them in their everyday life to be able to examine the brain under conditions of sleepiness They are engaged in activities with the research staff during this waking time
Functional magnetic resonance imaging Subjects undergo five separate fMRI scans-one during screening and four others during the main part of the study fMRI uses a magnetic field and radio waves to produce images of the brain The subject lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process Brain scans are taken at rest and while the subject performs tasks which include pressing a button upon seeing certain shapes and performing various language tasks such as saying memorized or new words listening to narratives and describing everyday procedures
Neurological speech-language and neuropsychological testing Before the fMRI exams and during the period of extended wakefulness subjects complete a series of tests that measure speech language memory and visual skills Portions of the tests may be video- or autiotaped
Interviews and questionnaires Participants are interviewed about their handedness sleep history and presence of medical or neurological symptoms
Electrophysiological studies Subjects have an electroencephalograph EEG to measure the electrical activity of the brain and surface electromyography EMG to measure movements of muscles involved in moving and speaking For the EEG electrodes small metal disks are attached to the surface of the scalp or to a cap placed over the head For the EMG electrodes are attached to the skin of the face and neck by plastic or paper tape
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
Extended wakefulness Subjects are kept awake longer than is normal for them in their everyday life to be able to examine the brain under conditions of sleepiness They are engaged in activities with the research staff during this waking time
Functional magnetic resonance imaging Subjects undergo five separate fMRI scans-one during screening and four others during the main part of the study fMRI uses a magnetic field and radio waves to produce images of the brain The subject lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process Brain scans are taken at rest and while the subject performs tasks which include pressing a button upon seeing certain shapes and performing various language tasks such as saying memorized or new words listening to narratives and describing everyday procedures
Neurological speech-language and neuropsychological testing Before the fMRI exams and during the period of extended wakefulness subjects complete a series of tests that measure speech language memory and visual skills Portions of the tests may be video- or autiotaped
Interviews and questionnaires Participants are interviewed about their handedness sleep history and presence of medical or neurological symptoms
Electrophysiological studies Subjects have an electroencephalograph EEG to measure the electrical activity of the brain and surface electromyography EMG to measure movements of muscles involved in moving and speaking For the EEG electrodes small metal disks are attached to the surface of the scalp or to a cap placed over the head For the EMG electrodes are attached to the skin of the face and neck by plastic or paper tape
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 eg EEG and behavioral measures eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-DC-0238 | None | None | None |