HealthyNCT00438438
Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance
A study testing forced desynchrony protocol with sleep restriction in people with Healthy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The primary objectives of the proposed experimental and modeling efforts are to quantify the influences of acute sleep deprivation (short-term homeostatic), chronic sleep restriction (long-term homeostatic), circadian rhythmicity, and their interactions on neurocognitive performance and to develop a new model of sleep… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- forced desynchrony protocol with sleep restriction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Nov 2008
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-35 years old
- Medically healthy
Who cannot join
- Sleep disorder
- Psychiatric illness
- Chronic medical condition
- No prescription or Non-prescription medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Woman's Hospital
Boston, Massachusetts, 02115
About this study
Official title: "Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance"
The primary objectives of the proposed experimental and modeling efforts are to quantify the influences of acute sleep deprivation (short-term homeostatic), chronic sleep restriction (long-term homeostatic), circadian rhythmicity, and their interactions on neurocognitive performance and to develop a new model of sleep homeostasis that can predict the effects of chronic sleep restriction. This model will be based on the underlying neuroanatomy and neurophysiology. This new model will facilitate optimization of human performance in operational settings, such as are seen in military operation and other work environments.
Read the detailed description
This protocol involves a baseline period consisting of 14 hours of wakefulness and 10 hour nocturnal sleep episodes each 24 hours. This is followed by a forced desynchrony regimen spanning 21 calendar days and consisting of 12 cycles ("days") of a 42.85-hour wake:bedrest schedule. In each 42.85 hour cycle, there are 32.85 hours of scheduled wakefulness and 10 hour sleep opportunities. This will allow assessment of the independent contributions of circadian phase and homeostatic sleep pressure on sleep and neurobehavioral performance. This forced desynchrony regimen is followed by 10 recovery days consisting of 14 hours of wakefulness and 10 hour nocturnal sleep episodes each 24 hours.
- Conditions
- Healthy
- Being tested
- forced desynchrony protocol with sleep restriction
- Keywords
- forced desynchrony, circadian rhythms, sleep restriction, sleep homeostasis, neurobehavioral performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forced desynchrony protocol with sleep restrictionBehavioural
Subjects are scheduled to live on a non-24 hour day. This separates the sleep-wake schedule from the near-24 hour circadian rhythm. This allows assessment of how circadian rhythms and the length-of-time awake contribute to sleepiness, alertness, and cognitive performance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Stage
Measured: 38 days
Circadian Phase (melatonin rhythm)
Measured: 38 days
Psychomotor Vigilance Task
Measured: 38 days
Digit Symbol Substitution Task
Measured: 38 days
Addition Task
Measured: 38 days
Karolinska Sleepiness Scale
Measured: 38 days
Karolinska Drowsiness Test
Measured: 38 days
Mood Scales
Measured: 38 days
Flanker Task
Measured: 38 days
Multiple Object Tracking
Measured: 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startApr 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth B. Klerman, Brigham and Women's Hospital
- Investigators
- Elizabeth B Klerman, M.D., Ph.D., Principal investigator, Brigham and Woman's HospitalCharles A Czeisler, Ph.D., M.D., Principal investigator, Brigham and Woman's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438438
- Sponsor's protocol ID
- 2200-100792
- Status last verified
- Aug 2011
- First submitted
- 20 Feb 2007
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance"
- ClinicalTrials.gov ID
- NCT00438438
- Acronym / sponsor ID
- 2200-100792
- Conditions
- Healthy
- Keywords
- forced desynchrony, circadian rhythms, sleep restriction, sleep homeostasis, neurobehavioral performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 22 Feb 2007 (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.
The primary objectives of the proposed experimental and modeling efforts are to quantify the influences of acute sleep deprivation (short-term homeostatic), chronic sleep restriction (long-term homeostatic), circadian rhythmicity, and their interactions on neurocognitive performance and to develop a new model of sleep homeostasis that can predict the effects of chronic sleep restriction. This model will be based on the underlying neuroanatomy and neurophysiology. This new model will facilitate optimization of human performance in operational settings, such as are seen in military operation and other work environments.
Detailed description
This protocol involves a baseline period consisting of 14 hours of wakefulness and 10 hour nocturnal sleep episodes each 24 hours. This is followed by a forced desynchrony regimen spanning 21 calendar days and consisting of 12 cycles ("days") of a 42.85-hour wake:bedrest schedule. In each 42.85 hour cycle, there are 32.85 hours of scheduled wakefulness and 10 hour sleep opportunities. This will allow assessment of the independent contributions of circadian phase and homeostatic sleep pressure on sleep and neurobehavioral performance. This forced desynchrony regimen is followed by 10 recovery days consisting of 14 hours of wakefulness and 10 hour nocturnal sleep episodes each 24 hours.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-35 years old
- Medically healthy
Key exclusion criteria (4 listed)
- Sleep disorder
- Psychiatric illness
- Chronic medical condition
- No prescription or Non-prescription medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| forced desynchrony protocol with sleep restrictionSubjects are scheduled to live on a non-24 hour day. This separates the sleep-wake schedule from the near-24 hour circadian rhythm. This allows assessment of how circadian rhythms and the length-of-time awake contribute to sleepiness, alertness, and cognitive performance. | Behavioural | – |
Primary outcome
Sleep Stage
Time frame: 38 days
Circadian Phase (melatonin rhythm)
Time frame: 38 days
Psychomotor Vigilance Task
Time frame: 38 days
Digit Symbol Substitution Task
Time frame: 38 days
Addition Task
Time frame: 38 days
Karolinska Sleepiness Scale
Time frame: 38 days
Karolinska Drowsiness Test
Time frame: 38 days
Mood Scales
Time frame: 38 days
Flanker Task
Time frame: 38 days
Multiple Object Tracking
Time frame: 38 days
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 2 Sep 2011.
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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.
Elizabeth B Klerman, M.D., Ph.D. principal investigator
Brigham and Woman's Hospital
Charles A Czeisler, Ph.D., M.D. principal investigator
Brigham and Woman's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing forced desynchrony protocol with sleep restriction in people with Healthy, run by Brigham and Women's Hospital 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 2 Sep 2011. 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.
What does the primary outcome measure?
Sleep Stage (time frame: 38 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2011.