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Sleep Disorders clinical trials

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NCT ID: NCT01774318 Recruiting - Clinical trials for Sleep Disorders, Circadian Rhythm

Early Development of Sleep-wake Cycles in Premature Infants and Its Impact on Neurodevelopmental Outcome

SWC
Start date: February 2012
Phase: N/A
Study type: Interventional

Due to the development of neonatal intensive care the number of surviving premature infants increased significantly. The immature brain undergoes a fair amount of external stimuli, which have a great impact on later cognitive development. Increasingly data show, that a delayed emergence of sleep-wake-cycling in newborns can be the first sign of brain injury. Studies have shown that clearly defined sleep states can be identified from 31-32 weeks of gestation onwards. But a few studies show, that also extremely premature infants already show cyclical variations of the background pattern within amplitude-integrated EEG (aEEG= a time-compressed, simplified EEG) and conventional EEG. This might resemble early sleep-wake-states and their presence correlates to the integrity of the central nervous system, although no clearly defined "sleep states" according to the classical definition can be identified. Complex EEG analysis needs the use of automated methods to exclude personal bias and to ensure gestational age specific data analysis. The newly developed NLEO algorithm was specially designed for EEG analysis of premature infants. Conventional EEG within this study will be analyzed visually and with the automated algorithm. In our research project we will study the emergence of Sleep-wake-cycling in extremely premature infants and its impact on their neurodevelopmental outcome prospectively. The different sleep and wake states will be derived from analysis of the conventional Video-EEG, aEEG and polysomnographic measurements. Visual analysis will include assessment of amplitudes and frequencies as well as the latencies and durations of EEG-Bursts and Interburst intervals. The automated NLEO-algorithm will be firstly used for comparison with above described visual analysis and secondly to find regions of interest involved in the organization of these early sleep states. The aim of this study is first to understand and analyze in detail the emergence of sleep-wake cycling including its disturbances in premature infants and to compare automated NLEO algorithm to conventional visual analysis methods. Secondly to correlate neurodevelopmental outcome to the emergence of sleep-wake-cycling.

NCT ID: NCT01672502 Completed - Clinical trials for Obstructive Sleep Apnea

Fire Fighter Fatigue Management Program: Operation Fight Fatigue

Start date: September 2012
Phase: N/A
Study type: Interventional

Firefighters frequently work extended duration shifts and long work weeks which have adverse effects on alertness, health, safety and performance. This protocol uses a survey instrument to examine the effects of extended duration shifts on safety outcomes (e.g., motor vehicle crashes, accidents, injuries), health (e.g., diagnosis and treatment of sleep disorders, improved general health indices, decreased number of sick days), and performance (e.g., decreased response time). This study will expand understanding of the nature, scope, etiology and consequences of firefighter fatigue and increase our ability to develop guidelines that can be generalized across fire departments throughout North America. This study could provide an avenue to make lasting policy improvements that could enhance the safety, health, and performance of firefighters.

NCT ID: NCT01669317 Completed - Insomnia Clinical Trials

Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content

CHERRY JUICE
Start date: June 2014
Phase: N/A
Study type: Interventional

This study is designed to demonstrate that cherry juice is effective in treating insomnia, and to show that it works by inhibiting an enzyme that will be measured in the blood.

NCT ID: NCT01667588 Completed - Clinical trials for Chronic Kidney Disease (CKD)

Sleep Disorders in Pediatric Dialysis

Start date: August 2012
Phase: N/A
Study type: Observational

Sleep disorders (SD) are common in adults with Chronic Kidney Disease (CKD) on dialysis with a reported prevalence of 60-80%. To date three studies have reported on SDs in children with CKD but these have all been based on questionnaire data alone. The findings were not confirmed with polysomnograms (PSG), the gold standard to diagnose SD, or actigraphy, a validated tool to assess the sleep/ wake cycle over a prolonged period in the home. This is highly relevant given the poor sensitivity and specificity of even validated questionnaires alone. The effect of untreated pediatric SD is pervasive. This study will provide the first objective assessment of SDs using PSGs in children with severe CKD, both on and off dialysis. Therefore, we will recognize and when possible treat SD in this severe CKD cohort potentially contributing to their immediate management (eg improved control of hypertension, improved school performance), while improving their Quality of Life (QOL) and helping ensure they achieve their full potential.

NCT ID: NCT01650454 Completed - Clinical trials for Cognitive Impairment

Sleep, Cognition and Memory Disorder

SCOAL
Start date: January 2013
Phase: N/A
Study type: Interventional

The increasing incidence of Alzheimer's disease (AD) and related sleep-disorders with the aging of the population is a major issue of public health. The prevalence of sleep disturbances is about 50% in dementia patients. Sleep in dementia is mainly characterized by prolonged night-time awakenings, sometimes with longer sleep latency and/or early awakening. The presence of these sleep disturbances is the main reason for the institutionalization of AD patients, as well as a major cause of the deterioration of the caregivers' sleep. The MEMENTO cohort is composed of patients with isolated memory complaints or mild cognitive impairment, at high risk to develop dementia. All voluntary patients from the CMRR (Center of Memory, resources and Research) of Bordeaux (MEMENTO cohort) will be tested at inclusion and followed-up 1 year later. For these two evaluations, actigraphic monitoring at home, 2-night polysomnography (PSG) monitoring at hospital including a 24-hour period of urinary melatonin dosage, neuropsychological tests battery, a virtual reality tool and questionnaires will be used.

NCT ID: NCT01638234 Completed - Atopic Dermatitis Clinical Trials

Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

Start date: January 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin may aid sleep and also has anti-inflammatory properties, and has been suggested in managing sleep disturbance in AD patients. However, there has been no large randomized controlled trials. Hence the objective of this double-blind randomized controlled study is to determine whether supplementing melatonin is effective in improving sleep problems in children with AD.

NCT ID: NCT01591408 Completed - Anxiety Clinical Trials

EEG Biofeedback Therapy as an Adjunct Treatment for PTSD

Start date: May 2012
Phase: N/A
Study type: Interventional

The proposed study, "Placebo-controlled study of EEG biofeedback therapy as an adjunct treatment for PTSD, evaluating symptoms and EEG dynamics", will investigate the brain dynamics associated with PTSD symptom reduction associated with EEG biofeedback therapy or sham EEG biofeedback in addition to treatment as usual at the NMCSD OASIS program. EEG biofeedback treatment protocols for PTSD and other disorders have been developed and honed by private practice clinicians over the past 25 years, during which EEG biofeedback has become an increasingly popular adjunct therapy. The reported success of EEG biofeedback as a non-drug intervention with lasting efficacy warrants a clinical study investigating not only symptom reduction, but also the underlying neurobiological mechanism. To this end, we propose a study using high density EEG recordings before and after treatment for PTSD symptoms to determine which brain activities correlate with reported symptom changes. The proposed study could expand treatment alternatives for servicemen with PTSD. If EEG biofeedback is shown to improve symptom reduction over the placebo controlled condition, it would offer a non-pharmacological intervention that would avoid undesirable side effects, and accelerate recovery compared with the current standard of care.

NCT ID: NCT01570738 Completed - Sleep Disorders Clinical Trials

Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory

Start date: July 2012
Phase:
Study type: Observational

Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem. The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in the age group of 6 and less and about 1.5% above. The in-lab sleep study using full Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the commonly used procedure of "split-night" for OSAS patients, as well as to the development of a variety of ambulatory sleep study systems. The primary study objective is to compare the efficacy of the WatchPAT (WP), as an ambulatory device for aiding in the diagnosis of sleep disorders for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a "gold standard".

NCT ID: NCT01558180 Completed - Insomnia Clinical Trials

Telephone Care Management to Address Sleep Problems in Young Children With Autism

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The investigators will conduct a randomized controlled trial comparing a telephone based intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series of phone calls to assist caregivers in learning and modifying behavioral strategies that may help young children with autism to sleep better. Objective (activity monitors) and subjective (rating scales) data will be collected by an independent research assistant at the end of the project. The investigators hypothesize that TCM improves sleep duration and decreases sleep problems relative to a usual care control condition (UC).

NCT ID: NCT01556074 Completed - Insomnia Clinical Trials

Evaluation of Yoga for Sleep Disturbances in Post Traumatic Stress Disorder (PTSD)

Start date: June 2012
Phase: N/A
Study type: Interventional

The primary objective of this preliminary study is to estimate sleep outcome effect sizes and determine feasibility for a novel yoga treatment of insomnia in participants with post traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible mechanisms of action.