SleepNCT01581125
Sleep Duration Required to Restore Performance During Chronic Sleep Restriction
A study testing Sleep:wake 1 and Sleep:wake 2 in people with Sleep and Sleep Deprivation, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Deprivation, Insufficient Sleep Syndrome
- What is being tested?
- Sleep:wake 1 and Sleep:wake 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2016
- 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
- Healthy
Who cannot join
- Prescription medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase.
Read the detailed description
The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. Inpatient sleep and performance data will be collected from healthy volunteers.
- Conditions
- Sleep, Sleep Deprivation, Insufficient Sleep Syndrome
- Being tested
- Sleep:wake 1, Sleep:wake 2
- Keywords
- Inpatients, Health Normalcy, circadian rhythm
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep:wake 1Behavioural
Sleep and Wake durations for arm 1
Sleep:wake 2Behavioural
Sleep and Wake durations for arm2
| Study group | Role | What they receive |
|---|---|---|
| Sleep:wake 2 | Experimental | Sleep and wake durations for arm 2 for inpatient portion of protocol. .There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 1. Receives: Behavioral: Sleep:wake 2 |
| Sleep:wake 1 | Experimental | Sleep and wake durations for arm 1 of the inpatient portion of the protocol. There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 2. Receives: Behavioral: Sleep:wake 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Vigilance Task (PVT) performance
PVT metrics are reaction time. It is measured when the participants are awake during the inpatient portion of the protocol.
Measured: PVT during waking for arms 1 and 2 during the 32-day inpatient portion of the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2016
- Study completionJun 2016
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 SleepStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
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, MD PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581125
- Sponsor's protocol ID
- NIH R01 HL114088-01
- Status last verified
- Jul 2016
- First submitted
- 22 Mar 2012
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
McHill AW, Hull JT, Cohen DA, Wang W, Czeisler CA, Klerman EB. Chronic sleep restriction greatly magnifies performance decrements immediately after awakening. Sleep. 2019 May 1;42(5):zsz032. doi: 10.1093/sleep/zsz032.
PubMed 30722039McHill AW, Hull JT, McMullan CJ, Klerman EB. Chronic Insufficient Sleep Has a Limited Impact on Circadian Rhythmicity of Subjective Hunger and Awakening Fasted Metabolic Hormones. Front Endocrinol (Lausanne). 2018 Jun 12;9:319. doi: 10.3389/fendo.2018.00319. eCollection 2018.
PubMed 29946297
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Duration Required to Restore Performance During Chronic Sleep Restriction
- ClinicalTrials.gov ID
- NCT01581125
- Acronym / sponsor ID
- NIH R01 HL114088-01
- Conditions
- Sleep, Sleep Deprivation, Insufficient Sleep Syndrome
- Keywords
- Inpatients, Health Normalcy, circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Apr 2012 (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 purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase.
Detailed description
The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. Inpatient sleep and performance data will be collected from healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep:wake 2 | Experimental | Behavioral: Sleep:wake 2Sleep and wake durations for arm 2 for inpatient portion of protocol. .There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 1. |
| Sleep:wake 1 | Experimental | Behavioral: Sleep:wake 1Sleep and wake durations for arm 1 of the inpatient portion of the protocol. There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 2. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Sleep:wake 1Sleep and Wake durations for arm 1 | Behavioural | Sleep:wake 1 |
| Sleep:wake 2Sleep and Wake durations for arm2 | Behavioural | Sleep:wake 2 |
Primary outcome
Psychomotor Vigilance Task (PVT) performance
Time frame: PVT during waking for arms 1 and 2 during the 32-day inpatient portion of the protocol
PVT metrics are reaction time. It is measured when the participants are awake during the inpatient portion of the protocol.
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 18 Jul 2016.
- Derived from this study: PubMed 30722039McHill AW, Hull JT, Cohen DA, Wang W, Czeisler CA, Klerman EB. Chronic sleep restriction greatly magnifies performance decrements immediately after awakening. Sleep. 2019 May 1;42(5):zsz032. doi: 10.1093/sleep/zsz032.
- Derived from this study: PubMed 29946297McHill AW, Hull JT, McMullan CJ, Klerman EB. Chronic Insufficient Sleep Has a Limited Impact on Circadian Rhythmicity of Subjective Hunger and Awakening Fasted Metabolic Hormones. Front Endocrinol (Lausanne). 2018 Jun 12;9:319. doi: 10.3389/fendo.2018.00319. eCollection 2018.
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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, MD PhD principal investigator
Brigham and Women'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 Sleep:wake 1 and Sleep:wake 2 in people with Sleep and Sleep Deprivation, 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 1 inclusion and 1 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 18 Jul 2016. 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 Task (PVT) performance (time frame: PVT during waking for arms 1 and 2 during the 32-day inpatient portion of the protocol). 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 NCT01581125, 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 18 Jul 2016.