ControlNCT02128737
Neurobehavioral Effects of Partial Sleep Deprivation
A study testing Sleep in people with Control and 1 Night Recovery Sleep, run by University of Pennsylvania at 1 site in United States.
Trial summary
This project continues an innovative line of research on how to optimally use sleep as an intervention to promote cognitive recovery from, and resistance to, the neurobehavioral risks posed by chronic partial sleep deprivation. Chronic insufficient sleep is estimated to affect at least 20% of adults. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Control, 1 Night Recovery Sleep, 3 Nights Recovery Sleep
- What is being tested?
- Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Apr 2015
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A total of N=87 adult subjects (aged 21-50 yr), N=43 females and N=44 males of all ethnicities, will be randomized to the 3 different conditions (n=26 for each of 2 experimental conditions; n=11 for the control condition) for the 17-night protocol or assigned to the 5-night experimental recovery condition (n=24) for the 19-night protocol. Subjects must also be comparable in terms of their homeostatic and circadian sleep-wake regulation parameters. In order to be eligible to participate, subjects must meet the following inclusion criteria:
- Age between 21 and 50 years (average age of our current protocols is 31 years)
- Body mass index (BMI) within 20.5% of normal
- Stable, normally-timed sleep-wake cycle as determined by interview, 2-week daily sleep log, and 2-week wrist actigraphic evidence, and defined by:
- Habitual nocturnal sleep duration between 6.5h and 8.5h
- Habitual morning awakening between 0600h and 0930h
Who cannot join
- No evidence of habitual napping
- No shift work, transmeridian travel or irregular sleep/wake routine in the past 60 days
- No sleep disorder, determined by history, actigraph, pulse oximetry and PSG
- No history of mania or psychosis
- No current depression as determined by the Beck Depression Inventory
- No alcohol or drug abuse in the past year based upon history and urine toxicology screen
- Not a current smoker
- No acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness, epilepsy, or thyroid disease, based on history, physical exam, blood and urine chemistries, and CBC
Trial locations and contacts
1 site in 1 country.
United States1 site
Unit for Experimental Psychiatry, Sleep and Chronobiology Laboratory
Philadelphia, Pennsylvania, 19104
About this study
This project continues an innovative line of research on how to optimally use sleep as an intervention to promote cognitive recovery from, and resistance to, the neurobehavioral risks posed by chronic partial sleep deprivation. Chronic insufficient sleep is estimated to affect at least 20% of adults. It can result from medical conditions and sleep disorders, as well as work demands, and social or domestic responsibilities. It is associated with significant clinical morbidity, and directly causes errors and accidents that are due to its adverse neurobehavioral effects on alertness, mood, and cognitive functions. In seminal experiments conducted under this grant, we showed that the neurobehavioral effects of chronic sleep restriction accumulate to severe levels in a few days, without the full awareness of the affected individuals, and that recovery from chronic sleep restriction requires more sleep than previously assumed. We also discovered that recovery from chronic sleep was illusory, because it masked a heightened neurobehavioral vulnerability to even a single post-recovery night of sleep restriction. The implications of these findings are that apparent recovery from chronic sleep restriction masks a more severe cognitive response to subsequent sleep restriction suggesting that there are longer time constants in the brain for neurobehavioral recovery from chronic sleep restriction. In light of this finding, we now seek to determine whether additional nights of extended recovery sleep will reduce the heightened vulnerability induced by prior exposure to sleep restriction. A total of 87 healthy adults (ages 21-50) will be studied in the laboratory during a 17-night (N=63) and a 19-night (N=24) protocol evaluating cognitive, psychological and physiological responses to varying recovery days between two sleep-restriction periods. The results will establish the number of nights of recovery sleep needed to prevent accelerated deterioration during a subsequent period of sleep restriction. The findings will advance theoretical understanding of sleep homeostasis and its relationship to cognitive functions, as well as inform theories of sleep need, and have substantial implications for sleep biology, for the treatment of clinical disorders that regularly disrupt sleep, and for managing lifestyle factors that frequently restrict sleep.
- Being tested
- Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 10 hours time-in-bed all nights of study |
| 1 Recovery Night | Experimental | 2 baseline nights, five nights sleep restriction, 1 recovery night, five nights sleep restriction, 4 recovery nights Receives: Behavioral: Sleep |
| 3 Recovery Nights | Experimental | 2 baseline nights, five nights sleep restriction, 3 recovery nights, five nights sleep restriction, 2 recovery nights Receives: Behavioral: Sleep |
| 5 Recovery Nights | Experimental | 2 baseline nights, five nights sleep restriction, 5 recovery nights, five nights sleep restriction, 1 recovery nights Receives: Behavioral: Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Vigilance Test
3, 10 or 20 minute simple, high-signal-load reaction time (RT)-based test invented by our group and designed to evaluate the ability to sustain attention and respond in a timely manner to salient signals.
Measured: Assessed everyday of the in-laboratory study (17 days) and is completed every 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startDec 2009
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ControlStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- David F Dinges, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128737
- Sponsor's protocol ID
- 810896
- Status last verified
- Apr 2014
- First submitted
- 10 Apr 2014
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Spaeth AM, Dinges DF, Goel N. Objective Measurements of Energy Balance Are Associated With Sleep Architecture in Healthy Adults. Sleep. 2017 Jan 1;40(1):zsw018. doi: 10.1093/sleep/zsw018.
PubMed 28364451Spaeth AM, Dinges DF, Goel N. Sex and race differences in caloric intake during sleep restriction in healthy adults. Am J Clin Nutr. 2014 Aug;100(2):559-66. doi: 10.3945/ajcn.114.086579. Epub 2014 Jun 25.
PubMed 24965304
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Effects of Partial Sleep Deprivation
- ClinicalTrials.gov ID
- NCT02128737
- Acronym / sponsor ID
- 810896
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Dec 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 May 2014 (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 project continues an innovative line of research on how to optimally use sleep as an intervention to promote cognitive recovery from, and resistance to, the neurobehavioral risks posed by chronic partial sleep deprivation. Chronic insufficient sleep is estimated to affect at least 20% of adults. It can result from medical conditions and sleep disorders, as well as work demands, and social or domestic responsibilities. It is associated with significant clinical morbidity, and directly causes errors and accidents that are due to its adverse neurobehavioral effects on alertness, mood, and cognitive functions. In seminal experiments conducted under this grant, we showed that the neurobehavioral effects of chronic sleep restriction accumulate to severe levels in a few days, without the full awareness of the affected individuals, and that recovery from chronic sleep restriction requires more sleep than previously assumed. We also discovered that recovery from chronic sleep was illusory, because it masked a heightened neurobehavioral vulnerability to even a single post-recovery night of sleep restriction. The implications of these findings are that apparent recovery from chronic sleep restriction masks a more severe cognitive response to subsequent sleep restriction suggesting that there are longer time constants in the brain for neurobehavioral recovery from chronic sleep restriction. In light of this finding, we now seek to determine whether additional nights of extended recovery sleep will reduce the heightened vulnerability induced by prior exposure to sleep restriction. A total of 87 healthy adults (ages 21-50) will be studied in the laboratory during a 17-night (N=63) and a 19-night (N=24) protocol evaluating cognitive, psychological and physiological responses to varying recovery days between two sleep-restriction periods. The results will establish the number of nights of recovery sleep needed to prevent accelerated deterioration during a subsequent period of sleep restriction. The findings will advance theoretical understanding of sleep homeostasis and its relationship to cognitive functions, as well as inform theories of sleep need, and have substantial implications for sleep biology, for the treatment of clinical disorders that regularly disrupt sleep, and for managing lifestyle factors that frequently restrict sleep.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –10 hours time-in-bed all nights of study |
| 1 Recovery Night | Experimental | Behavioral: Sleep2 baseline nights, five nights sleep restriction, 1 recovery night, five nights sleep restriction, 4 recovery nights |
| 3 Recovery Nights | Experimental | Behavioral: Sleep2 baseline nights, five nights sleep restriction, 3 recovery nights, five nights sleep restriction, 2 recovery nights |
| 5 Recovery Nights | Experimental | Behavioral: Sleep2 baseline nights, five nights sleep restriction, 5 recovery nights, five nights sleep restriction, 1 recovery nights |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A total of N=87 adult subjects (aged 21-50 yr), N=43 females and N=44 males of all ethnicities, will be randomized to the 3 different conditions (n=26 for each of 2 experimental conditions; n=11 for the control condition) for the 17-night protocol or assigned to the 5-night experimental recovery condition (n=24) for the 19-night protocol. Subjects must also be comparable in terms of their homeostatic and circadian sleep-wake regulation parameters. In order to be eligible to participate, subjects must meet the following inclusion criteria:
- Age between 21 and 50 years (average age of our current protocols is 31 years)
- Body mass index (BMI) within 20.5% of normal
- Stable, normally-timed sleep-wake cycle as determined by interview, 2-week daily sleep log, and 2-week wrist actigraphic evidence, and defined by:
- Habitual nocturnal sleep duration between 6.5h and 8.5h
Key exclusion criteria (8 listed)
- No evidence of habitual napping
- No shift work, transmeridian travel or irregular sleep/wake routine in the past 60 days
- No sleep disorder, determined by history, actigraph, pulse oximetry and PSG
- No history of mania or psychosis
- No current depression as determined by the Beck Depression Inventory
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 |
|---|---|---|
| Sleep | Behavioural | 1 Recovery Night, 3 Recovery Nights, 5 Recovery Nights |
Primary outcome
Psychomotor Vigilance Test
Time frame: Assessed everyday of the in-laboratory study (17 days) and is completed every 2 hours
3, 10 or 20 minute simple, high-signal-load reaction time (RT)-based test invented by our group and designed to evaluate the ability to sustain attention and respond in a timely manner to salient signals.
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 11 Jun 2015.
- Derived from this study: PubMed 28364451Spaeth AM, Dinges DF, Goel N. Objective Measurements of Energy Balance Are Associated With Sleep Architecture in Healthy Adults. Sleep. 2017 Jan 1;40(1):zsw018. doi: 10.1093/sleep/zsw018.
- Derived from this study: PubMed 24965304Spaeth AM, Dinges DF, Goel N. Sex and race differences in caloric intake during sleep restriction in healthy adults. Am J Clin Nutr. 2014 Aug;100(2):559-66. doi: 10.3945/ajcn.114.086579. Epub 2014 Jun 25.
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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.
David F Dinges, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep in people with Control and 1 Night Recovery Sleep, run by University of Pennsylvania 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 6 inclusion and 8 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 11 Jun 2015. 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?
Psychomotor Vigilance Test (time frame: Assessed everyday of the in-laboratory study (17 days) and is completed every 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128737, which also lists 2 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 11 Jun 2015.