Sleep DisordersNCT00001546
Circadian Regulation of Sleep in Habitual Short Sleepers and Long Sleepers
An observational study of Sleep Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Routine sleep duration varies greatly among individuals. The biological meaning of this variation is unknown. The term circadian rhythm refers to the biological clock that regulates the timing of falling asleep, waking up, and secretion of hormones, like melatonin. Melatonin is secreted at night. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- May 1996to Jun 2000
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Sleep greater than or equal to 9 hours almost every night.
Sleep less than or equal to 6 hours almost every night.
Between ages 20-30.
No medications, history of psychiatric illness, history of head injury.
No sleep disturbances.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Routine sleep duration varies greatly among individuals. The biological meaning of this variation is unknown.
The term circadian rhythm refers to the biological clock that regulates the timing of falling asleep, waking up, and secretion of hormones, like melatonin. Melatonin is secreted at night. Previous studies have shown that melatonin may play a role in the regulation of sleep.
Read more
The purpose of this study is to learn whether the duration of nighttime (nocturnal) melatonin secretion is longer in people with long regular sleep duration than people with short sleep duration.
Researchers will compare levels of melatonin and cortisol, body temperature, sleepiness, and sleep in two extreme groups. Group one will be made up of people with short sleep duration lasting less than 6 hours. Group two will be made up of people with long sleep duration lasting more than 9 hours.
Read the detailed description
Habitual sleep duration varies greatly among individuals. The biological meaning of this variation is unknown. The present project proposes that differences in habitual sleep duration are associated with differences in the output of the endogenous circadian pacemaker, which programs the 'internal biological night'. The protocol hypothesizes that the duration of the internal biological night as defined by the nocturnal intervals of detectable plasma melatonin levels, low body temperature, low EEG activity in the high-frequency alpha band, increasing sleepiness and increasing plasma cortisol levels is longer in habitual long sleepers (sleep duration greater than 9 hours) than in short sleepers (less than 6 hours). Since recent results in healthy subjects suggest that melatonin has some soporific or hypnotic properties, we furthermore hypothesize that the level of nocturnal melatonin secretion is higher in long sleepers than in short sleepers. The circadian rhythms of plasma melatonin, body temperature, waking EEG activity, subjective sleepiness and plasma cortisol will be assessed in a ~40-hour constant routine protocol. In addition, a 36-hour extended bed rest protocol will be carried out in order to study spontaneous sleep duration and sleep structure under ad lib conditions while time cues and social cues are absent. It is hypothesized that as a consequence of differences in the circadian output, long sleepers will sleep more, have a different sleep structure, and spontaneously wake up on a lower level of homeostatic sleep pressure than short sleepers. Finally, we intend to determine whether differences in habitual sleep duration between long and short sleepers are associated with dysthymic and hypomanic characteristics of mood, respectively. We are asking to study a total of 15 long sleepers and 15 short sleepers. Given that we have already studied 9 long sleepers and 9 short sleepers, we anticipate that 72 patient-days per year for one year would be required to complete the study.
- Conditions
- Sleep Disorders
- Keywords
- Biochemical Screening, Body Temperature, Consent Form, EEG, EKG, Melatonin, Mood, Physical Examination, Psychiatric Examination, Sleep Duration, Sleep Disorders
- Medical subject headings
- Sleep Wake Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMay 1996
- Study completionJun 2000
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 DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Enrolment
- 38 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001546
- Sponsor's protocol ID
- 960087
- Other IDs
- 96-M-0087
- Status last verified
- Apr 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Borbely AA. A two process model of sleep regulation. Hum Neurobiol. 1982;1(3):195-204. No abstract available.
PubMed 7185792Aeschbach 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 8769783Borbely AA, Baumann F, Brandeis D, Strauch I, Lehmann D. Sleep deprivation: effect on sleep stages and EEG power density in man. Electroencephalogr Clin Neurophysiol. 1981 May;51(5):483-95. doi: 10.1016/0013-4694(81)90225-x.
PubMed 6165548
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Regulation of Sleep in Habitual Short Sleepers and Long Sleepers
- ClinicalTrials.gov ID
- NCT00001546
- Acronym / sponsor ID
- 960087
- Conditions
- Sleep Disorders
- Keywords
- Biochemical Screening, Body Temperature, Consent Form, EEG, EKG, Melatonin, Mood, Physical Examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- May 1996
- Study completion
- Jun 2000
- First posted
- 10 Dec 2002 (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.
Routine sleep duration varies greatly among individuals. The biological meaning of this variation is unknown.
The term circadian rhythm refers to the biological clock that regulates the timing of falling asleep, waking up, and secretion of hormones, like melatonin. Melatonin is secreted at night. Previous studies have shown that melatonin may play a role in the regulation of sleep.
The purpose of this study is to learn whether the duration of nighttime (nocturnal) melatonin secretion is longer in people with long regular sleep duration than people with short sleep duration.
Researchers will compare levels of melatonin and cortisol, body temperature, sleepiness, and sleep in two extreme groups. Group one will be made up of people with short sleep duration lasting less than 6 hours. Group two will be made up of people with long sleep duration lasting more than 9 hours.
Detailed description
Habitual sleep duration varies greatly among individuals. The biological meaning of this variation is unknown. The present project proposes that differences in habitual sleep duration are associated with differences in the output of the endogenous circadian pacemaker, which programs the 'internal biological night'. The protocol hypothesizes that the duration of the internal biological night as defined by the nocturnal intervals of detectable plasma melatonin levels, low body temperature, low EEG activity in the high-frequency alpha band, increasing sleepiness and increasing plasma cortisol levels is longer in habitual long sleepers (sleep duration greater than 9 hours) than in short sleepers (less than 6 hours). Since recent results in healthy subjects suggest that melatonin has some soporific or hypnotic properties, we furthermore hypothesize that the level of nocturnal melatonin secretion is higher in long sleepers than in short sleepers. The circadian rhythms of plasma melatonin, body temperature, waking EEG activity, subjective sleepiness and plasma cortisol will be assessed in a ~40-hour constant routine protocol. In addition, a 36-hour extended bed rest protocol will be carried out in order to study spontaneous sleep duration and sleep structure under ad lib conditions while time cues and social cues are absent. It is hypothesized that as a consequence of differences in the circadian output, long sleepers will sleep more, have a different sleep structure, and spontaneously wake up on a lower level of homeostatic sleep pressure than short sleepers. Finally, we intend to determine whether differences in habitual sleep duration between long and short sleepers are associated with dysthymic and hypomanic characteristics of mood, respectively. We are asking to study a total of 15 long sleepers and 15 short sleepers. Given that we have already studied 9 long sleepers and 9 short sleepers, we anticipate that 72 patient-days per year for one year would be required to complete the study.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 4 Mar 2008.
- Background: PubMed 7185792Borbely AA. A two process model of sleep regulation. Hum Neurobiol. 1982;1(3):195-204. No abstract available.
- 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.
- Background: PubMed 6165548Borbely AA, Baumann F, Brandeis D, Strauch I, Lehmann D. Sleep deprivation: effect on sleep stages and EEG power density in man. Electroencephalogr Clin Neurophysiol. 1981 May;51(5):483-95. doi: 10.1016/0013-4694(81)90225-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 NCT00001546, 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 4 Mar 2008.