NCT00179322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2005

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
Same day until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
11 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

December 17, 2019

Status Verified

September 30, 2016

First QC Date

September 15, 2005

Last Update Submit

December 14, 2019

Conditions

Keywords

Sleep ArchitectureSleep MeasuresSpeech ArticulationCerebral PerfusionNeuroimagingHealthy VolunteerHV

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Women who are pregnant will be excluded from this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • ASERINSKY E, KLEITMAN N. Regularly occurring periods of eye motility, and concomitant phenomena, during sleep. Science. 1953 Sep 4;118(3062):273-4. doi: 10.1126/science.118.3062.273. No abstract available.

    PMID: 13089671BACKGROUND
  • Bechara A, Damasio AR, Damasio H, Anderson SW. Insensitivity to future consequences following damage to human prefrontal cortex. Cognition. 1994 Apr-Jun;50(1-3):7-15. doi: 10.1016/0010-0277(94)90018-3.

    PMID: 8039375BACKGROUND
  • Bechara A, Tranel D, Damasio H, Damasio AR. Failure to respond autonomically to anticipated future outcomes following damage to prefrontal cortex. Cereb Cortex. 1996 Mar-Apr;6(2):215-25. doi: 10.1093/cercor/6.2.215.

    PMID: 8670652BACKGROUND

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Allen R Braun, M.D.

    National Institute on Deafness and Other Communication Disorders (NIDCD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 15, 2005

Study Start

September 10, 2005

Study Completion

September 30, 2016

Last Updated

December 17, 2019

Record last verified: 2016-09-30

Locations