Clinical Trials Logo

Clinical Trial Summary

This research will examine why sleep restriction reduces the body clock's response to bright light. The results will enable the optimization of the bright light treatment of people who suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet lag, delayed sleep phase syndrome and winter depression, thereby improving public health and safety, well-being, mood, mental function, and quality of life.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT00843843
Study type Interventional
Source Rush University Medical Center
Contact
Status Completed
Phase N/A
Start date March 2008
Completion date February 2014

See also
  Status Clinical Trial Phase
Completed NCT02188498 - Electrocardiography Data Analysis in Sleep Disorders
Completed NCT00990106 - Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00163670 - The Impact of Sleep Disorders on Motor Vehicle Accidents N/A
Completed NCT00256685 - Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause Phase 3
Completed NCT00203827 - Pediatric Sleep Questionnaire: Use for Collection of Clinical Data N/A
Completed NCT00174174 - Provigil (Modafinil) Study by Taiwan Biotech Co. N/A
Terminated NCT00750919 - Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007) Phase 3
Completed NCT02939586 - The Effect of Haemodialysis in Sleep Apnoea N/A
Completed NCT03075241 - Z-Drugs for Sleep Disorders in Alzheimer's Disease Phase 3
Completed NCT02585609 - Sleep Quality in Patients With Advanced Cancer N/A
Completed NCT03055156 - Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms N/A
Completed NCT01929447 - Evaluation of WP200 With the Unified Probe (WP200U) N/A
Completed NCT02156128 - Subjective Memory Complaints, Objective Memory Performance and Cognitive Training N/A
Completed NCT01906866 - Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities Phase 3
Completed NCT01528462 - Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
Completed NCT01256983 - Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation Phase 0
Completed NCT01220401 - Efficacy of a Brief Nightmare Treatment for Veterans N/A
Not yet recruiting NCT00749814 - Sleep Disturbances in Hospitalized Children Phase 4
Completed NCT00518986 - Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression Phase 4