Sleep DeprivationNCT00179322
Effects of Sleep Deprivation and Recovery on Cognitive Functions
An observational study of Sleep Deprivation, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Sleep Deprivation
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2005to 30 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Sleep Deprivation
- Keywords
- Sleep Architecture, Sleep Measures, Speech Articulation, Cerebral Perfusion, Neuroimaging, Healthy Volunteer, HV
- Medical subject headings
- Sleep Deprivation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study start10 Sep 2005
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Allen R Braun, M.D., Principal investigator, National Institute on Deafness and Other Communication Disorders (NIDCD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179322
- Sponsor's protocol ID
- 050238
- Other IDs
- 05-DC-0238
- Status last verified
- 30 Sep 2016
- First submitted
- 15 Sep 2005
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
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.
PubMed 13089671Bechara 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.
PubMed 8039375Bechara 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.
PubMed 8670652
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Deprivation and Recovery Sleep on Speech, Language and Other Higher Cognitive Functions: A Combined EEG-fMRI Study
- ClinicalTrials.gov ID
- NCT00179322
- Acronym / sponsor ID
- 050238
- Conditions
- Sleep Deprivation
- Keywords
- Sleep Architecture, Sleep Measures, Speech Articulation, Cerebral Perfusion, Neuroimaging, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- 10 Sep 2005
- Study completion
- 30 Sep 2016
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 13089671ASERINSKY 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.
- Background: PubMed 8039375Bechara 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.
- Background: PubMed 8670652Bechara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen R Braun, M.D. principal investigator
National Institute on Deafness and Other Communication Disorders (NIDCD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00179322, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.