- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00843843
Sleep Length and Circadian Regulation in Humans (HAM)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Millions of Americans suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet lag, delayed sleep phase syndrome and possibly winter depression. These conditions are typically characterized by persistent insomnia and/or excessive daytime sleepiness, impaired performance, and gastrointestinal distress. These negative symptoms result from a misalignment between the timing of the external social world and the timing of the internal circadian (body) clock. Circadian rhythm sleep disorders are effectively treated with bright light, which phase shifts the circadian clock, thereby realigning it with the timing of the external social world.
It is widely recognized that social influences have led to an increasing prevalence of sleep restriction in modern society. We recently demonstrated for the first time that short sleep episodes, when compared to long sleep episodes, markedly reduce phase advances to bright light. Thus when people cut their sleep short, they inadvertently reduce their circadian responsiveness to bright light. The mechanism(s) behind these reduced phase shifts to light are unknown. However, there are at least two aspects of short sleep episodes that could be responsible for this effect. First, short sleep episodes are associated with partial sleep deprivation. Second, as humans sleep with their eyes closed and are usually exposed to light when awake, short sleep episodes are also associated with short dark lengths. Our overall goal is to determine the biobehavioral mechanisms by which short sleep episodes impair phase shifts to bright light. Specific Aim 1 is to determine the effect of partial sleep deprivation on phase advances to light, while controlling for dark length. Specific Aim 2 is to determine the effect of short dark lengths on phase advances to light while minimizing sleep deprivation. We will estimate the timing of the human circadian clock by measuring salivary melatonin, a neuroendocrine hormone released from the pineal gland, and collecting measures of sleep via actigraphy, and sleepiness, mood, gastrointestinal distress and cognitive performance via computerized assessment.
Characterization of the separate effects of sleep deprivation and dark length on circadian phase shifts to light in humans is critical to understanding how humans respond to light during their daily life activities. Furthermore, the findings of this research will produce important and practical recommendations for avoiding decrements to phase shifts to light, thereby optimizing the bright light treatment of circadian rhythm sleep disorders, and thus improving public health and safety, well-being, mood, cognitive function, and quality of life.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60612
- Biological Rhythms Research Laboratory, RUMC
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- healthy adult volunteers
Exclusion Criteria:
- color blindness with the Ishihara test
- obese people (BMI > 30)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: 9 hour sleep, then 3 hour nap and 6 hour sleep
|
Bright light of about 5000 lux, administered while sitting at a desk.
|
Comparador activo: 3 hour nap and 6 hour sleep, then 9 hour sleep
|
Bright light of about 5000 lux, administered while sitting at a desk.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Dim Light Melatonin Onset (Hours)
Periodo de tiempo: 12 days from baseline to final dim light melatonin onset
|
Gold standard marker of circadian timing
|
12 days from baseline to final dim light melatonin onset
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Psychomotor Vigilance
Periodo de tiempo: after short or long nights
|
Fastest 10% reaction time (msec)
|
after short or long nights
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Helen Burgess, PhD, Rush University Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HL083971
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Bright light box
-
University of California, San FranciscoNational Institute of Mental Health (NIMH)TerminadoVIH | Adherencia a la medicaciónIndia
-
Nationwide Children's HospitalTerminadoDepresión | Fibrosis quísticaEstados Unidos
-
Chang Gung Memorial HospitalTerminadoSíntoma inducido por hemodiálisis | Hipotensión intradialíticaTaiwán
-
Indiana UniversityHealth Information Technology Solutions (HITS) LLCRetiradoTrastorno de salud mental | Trastorno de estrés postraumático | Trastornos por uso de sustancias | Comportamiento adolescente
-
University of PennsylvaniaKarolinska University Hospital; Leiden University Medical Center; Vittore Buzzi... y otros colaboradoresTerminadoResucitación | Respiración con presión positiva | Prematuridad neonatalEstados Unidos
-
Yale UniversityNational Institutes of Health (NIH); National Center for Research Resources (NCRR)TerminadoIntolerancia a la glucosaEstados Unidos
-
Wearable Robotics srl.Azienda Ospedaliero, Universitaria Pisana; University Hospital, Geneva; Ecole Polytechnique...Terminado
-
Bright Dairy & Food Co., LtdTerminadoSalud intestinalPorcelana
-
Universidade Federal de PernambucoTerminadoEnfermedad de ParkinsonBrasil
-
Lara McKenzieTerminado