- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00607204
Examining the Biological Factors That Affect Sleep Duration
Neurobiology of Individual Differences in Sleep Duration
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Brigham & Women's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Routinely sleeps 6.5 hours or less a night, or routinely sleeps 9 hours or more a night
- In good health
Exclusion Criteria:
- Diagnosed with a sleep disorder
- Currently uses medications
- Performed night shift work in the 3 years before study entry
- History of psychiatric illness
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Circadian rhythm assessment based on plasma melatonin and other hormones; sleep and EEG analysis; measurements of cognitive performance, alertness, and mood
Tidsramme: Measured during the 4-week inpatient stay
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Measured during the 4-week inpatient stay
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Daniel Aeschbach, PhD, Brigham & Women's Hospital, Boston, MA
Publikationer og nyttige links
Generelle publikationer
- 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.
- Aeschbach 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.
- Aeschbach 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 559
- R01HL077399 (U.S. NIH-bevilling/kontrakt)
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Kliniske forsøg med Søvn
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University of Wisconsin, MadisonPhilips HealthcareAfsluttetSøvn, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
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Aventure ABAktiv, ikke rekrutterende
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National Taiwan University HospitalUkendt
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National University of SingaporeRekrutteringReduktion af skærmbrug + Sleep Extension | Frit levendeSingapore
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The First Affiliated Hospital of Shanxi Medical...Shanxi Medical UniversityAfsluttetSøvnkvalitet | Søvnvarighed | Sleep Onset LatencyKina
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Northwell HealthJazz PharmaceuticalsRekrutteringElektrisk status Epilepticus af Slow-Wave SleepForenede Stater
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University of Geneva, SwitzerlandAfsluttetNatlige benkramper | Sleep Wake Transition DisordersSchweiz
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Tyco Healthcare GroupUkendt
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Maastricht University Medical CenterEpilepsiecentrum KempenhaegheAfsluttetRolandsk Epilepsi | Landau-Kleffners syndrom | Natlig frontallappens epilepsi | Elektrisk status Epilepticus under Slow Wave SleepHolland