SleepNCT00607204
Examining the Biological Factors That Affect Sleep Duration
An observational study of Sleep and Circadian Rhythm, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Sleep is necessary for healthy functioning, and people who sleep too little or too much may have an increased risk of developing health problems. This study will examine people who regularly sleep for short or long amounts of time to understand the biological factors that determine how much sleep a person needs. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Circadian Rhythm, Cognitive Performance
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Nov 2011
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will include healthy people who are catagorized as either short sleepers or long sleepers.
Who may be able to join
- Routinely sleeps 6.5 hours or less a night, or routinely sleeps 9 hours or more a night
- In good health
Who cannot join
- Diagnosed with a sleep disorder
- Currently uses medications
- Performed night shift work in the 3 years before study entry
- History of psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Neurobiology of Individual Differences in Sleep Duration
Sleep is necessary for healthy functioning, and people who sleep too little or too much may have an increased risk of developing health problems. This study will examine people who regularly sleep for short or long amounts of time to understand the biological factors that determine how much sleep a person needs.
Read the detailed description
The amount of sleep people require depends on many factors, including age, but experts agree that most adults need 7 to 8 hours of sleep a night. People who sleep for shorter or longer amounts of time may be at risk of developing memory problems, heart disease, obesity, and diabetes. The duration and timing of sleep are regulated by an interaction between the circadian pacemaker, or biological clock, and the sleep homeostat, which is an internal account of the amount of sleep a person has received recently. It is unknown whether there is a biological or genetic basis for the amount of sleep a person needs. This inpatient study will examine two extreme sleep groups: short sleepers who sleep 6.5 or less hours a night and long sleepers who sleep 9 or more hours a night. Participants will be exposed to identical sleep opportunities and living conditions. Using hormone analysis to examine participants' circadian rhythms, researchers will evaluate the biological differences that people undergo during the sleep process. Results from this study may help researchers understand whether sleep duration and sleep needs differ among people because of biological and genetic variations.
Over a period of 4 to 6 weeks, potential study participants will attend 4 to 6 screening visits, which will include a medical history review, physical exam, blood and urine collection, electrocardiogram (EKG) to measure electrical activity of the heart, a psychological assessment, and an overnight stay in a sleep laboratory. For 3 weeks, potential participants will also wear an activity monitor, and they will record sleep habits electronically and in a daily diary.
Participants who are eligible for the study will spend 28 days in the Intensive Physiological Monitoring Unit of the Clinical and Translational Sciences Center at the Brigham and Women's Hospital. Participants will not have access to a clock, radio, television, or computer, and they will not be allowed any outside contact. Most days participants will remain in bed for 10 to 14 hours; however, at selected times during the study, participants will remain inactive for periods of 32 to 64 hours and will stay awake for 32 to 40 hours. Throughout the study, participants' sleep patterns will be monitored continuously by a wrist activity recorder. Heart rhythms, brain electrical activity, eye movements, and temperature will also be measured continuously. At different times throughout the study, participants will undergo urine, saliva, and blood collection; alertness, mood, and performance evaluations; and blood pressure measurements. Upon release from the research center, participants will maintain a sleep diary for 3 weeks.
- Conditions
- Sleep, Circadian Rhythm, Cognitive Performance
- Keywords
- Basic Research, Individual Sleep Duration, Melatonin, Electroencephalogram, Alertness, Mood
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian rhythm assessment based on plasma melatonin and other hormones; sleep and EEG analysis; measurements of cognitive performance, alertness, and mood
Measured: Measured during the 4-week inpatient stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startOct 2005
- Primary completionNov 2011
- Study completionNov 2011
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Daniel Aeschbach, Brigham and Women's Hospital
- Investigators
- Daniel Aeschbach, PhD, Principal investigator, Brigham & Women's Hospital, Boston, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607204
- Sponsor's protocol ID
- 559
- Other IDs
- R01HL077399
- Status last verified
- Jul 2013
- First submitted
- 4 Feb 2008
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Aeschbach D, Sher L, Postolache TT, Matthews JR, Jackson MA, Wehr TA. A longer biological night in long sleepers than in short sleepers. J Clin Endocrinol Metab. 2003 Jan;88(1):26-30. doi: 10.1210/jc.2002-020827.
PubMed 12519823Aeschbach D, Postolache TT, Sher L, Matthews JR, Jackson MA, Wehr TA. Evidence from the waking electroencephalogram that short sleepers live under higher homeostatic sleep pressure than long sleepers. Neuroscience. 2001;102(3):493-502. doi: 10.1016/s0306-4522(00)00518-2.
PubMed 11226688Aeschbach D, Cajochen C, Landolt H, Borbely AA. Homeostatic sleep regulation in habitual short sleepers and long sleepers. Am J Physiol. 1996 Jan;270(1 Pt 2):R41-53. doi: 10.1152/ajpregu.1996.270.1.R41.
PubMed 8769783
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiology of Individual Differences in Sleep Duration
- ClinicalTrials.gov ID
- NCT00607204
- Acronym / sponsor ID
- 559
- Conditions
- Sleep, Circadian Rhythm, Cognitive Performance
- Keywords
- Basic Research, Individual Sleep Duration, Melatonin, Electroencephalogram, Alertness, Mood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)
- Study start
- Oct 2005
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 5 Feb 2008 (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.
Sleep is necessary for healthy functioning, and people who sleep too little or too much may have an increased risk of developing health problems. This study will examine people who regularly sleep for short or long amounts of time to understand the biological factors that determine how much sleep a person needs.
Detailed description
The amount of sleep people require depends on many factors, including age, but experts agree that most adults need 7 to 8 hours of sleep a night. People who sleep for shorter or longer amounts of time may be at risk of developing memory problems, heart disease, obesity, and diabetes. The duration and timing of sleep are regulated by an interaction between the circadian pacemaker, or biological clock, and the sleep homeostat, which is an internal account of the amount of sleep a person has received recently. It is unknown whether there is a biological or genetic basis for the amount of sleep a person needs. This inpatient study will examine two extreme sleep groups: short sleepers who sleep 6.5 or less hours a night and long sleepers who sleep 9 or more hours a night. Participants will be exposed to identical sleep opportunities and living conditions. Using hormone analysis to examine participants' circadian rhythms, researchers will evaluate the biological differences that people undergo during the sleep process. Results from this study may help researchers understand whether sleep duration and sleep needs differ among people because of biological and genetic variations.
Over a period of 4 to 6 weeks, potential study participants will attend 4 to 6 screening visits, which will include a medical history review, physical exam, blood and urine collection, electrocardiogram (EKG) to measure electrical activity of the heart, a psychological assessment, and an overnight stay in a sleep laboratory. For 3 weeks, potential participants will also wear an activity monitor, and they will record sleep habits electronically and in a daily diary.
Participants who are eligible for the study will spend 28 days in the Intensive Physiological Monitoring Unit of the Clinical and Translational Sciences Center at the Brigham and Women's Hospital. Participants will not have access to a clock, radio, television, or computer, and they will not be allowed any outside contact. Most days participants will remain in bed for 10 to 14 hours; however, at selected times during the study, participants will remain inactive for periods of 32 to 64 hours and will stay awake for 32 to 40 hours. Throughout the study, participants' sleep patterns will be monitored continuously by a wrist activity recorder. Heart rhythms, brain electrical activity, eye movements, and temperature will also be measured continuously. At different times throughout the study, participants will undergo urine, saliva, and blood collection; alertness, mood, and performance evaluations; and blood pressure measurements. Upon release from the research center, participants will maintain a sleep diary for 3 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will include healthy people who are catagorized as either short sleepers or long sleepers.
Key inclusion criteria (2 listed)
- Routinely sleeps 6.5 hours or less a night, or routinely sleeps 9 hours or more a night
- In good health
Key exclusion criteria (4 listed)
- Diagnosed with a sleep disorder
- Currently uses medications
- Performed night shift work in the 3 years before study entry
- History of psychiatric illness
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
Circadian rhythm assessment based on plasma melatonin and other hormones; sleep and EEG analysis; measurements of cognitive performance, alertness, and mood
Time frame: Measured during the 4-week inpatient stay
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 31 Jul 2013.
- Background: PubMed 12519823Aeschbach D, Sher L, Postolache TT, Matthews JR, Jackson MA, Wehr TA. A longer biological night in long sleepers than in short sleepers. J Clin Endocrinol Metab. 2003 Jan;88(1):26-30. doi: 10.1210/jc.2002-020827.
- Background: PubMed 11226688Aeschbach D, Postolache TT, Sher L, Matthews JR, Jackson MA, Wehr TA. Evidence from the waking electroencephalogram that short sleepers live under higher homeostatic sleep pressure than long sleepers. Neuroscience. 2001;102(3):493-502. doi: 10.1016/s0306-4522(00)00518-2.
- Background: PubMed 8769783Aeschbach D, Cajochen C, Landolt H, Borbely AA. Homeostatic sleep regulation in habitual short sleepers and long sleepers. Am J Physiol. 1996 Jan;270(1 Pt 2):R41-53. doi: 10.1152/ajpregu.1996.270.1.R41.
Related trials for Sleep
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Impact Of Aerobic Exercise on Sleep Quality and Postural Control Interplay Among University Students
Healthy Individuals
Not yet recruitingObservational study
Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery
Recovery of Function, Postoperative Period
RecruitingObservational study
Observational Analytical Validation Study of the Replior ScratchSense
Atopic Dermatitis, Other Pruritic Dermatological
RecruitingObservational study
Oura Ring OA15 Validation
Healthy Adult, Sleep Apnea
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.
Daniel Aeschbach, PhD principal investigator
Brigham & Women's Hospital, Boston, MA
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 and Circadian Rhythm, 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 31 Jul 2013. 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?
Circadian rhythm assessment based on plasma melatonin and other hormones; sleep and EEG analysis; measurements of cognitive performance, alertness, and mood (time frame: Measured during the 4-week inpatient stay). 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 NCT00607204, 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 31 Jul 2013.