View clinical trials related to Parasomnias.
Filter by:This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).
Background Sleep disturbances are prevalent in hospitalized adult patients manifested as reduced sleep time and sleep efficiency as well as increased awakenings. Insomnia is the most frequent sleep disturbance. The effect of the change in sleep patterns in children prior to and after an elective surgery has not been evaluated objectively. Sleep in hospital may influence biological processes related to circadian rhythm. Melatonin is a hormone secreted by the pineal gland in a diurnal rhythm regulated by light- light suppresses melatonin secretion, while darkness enhances it. Melatonin has both chrono-biotic and sleep promoting properties. Exogenous administration of melatonin shortens sleep latency, increases sleep efficiency and total sleep time. Melatonin also improves disrupted circadian rhythm. Melatonin promotes sleep in a similar way to the natural sleep process, and maintains normal sleep architecture. Melatonin has a positive effect on children with sleep disturbances and is routinely administrated in pediatric sleep centers around the world for insomnia and a variety of sleep disorders. Side effects of melatonin are rare and scarce. Circadin is a slow released formulation of melatonin, which mimics night time secretion of natural melatonin. Children with sleep disorders who were treated with controlled release melatonin, demonstrated improvement in sleep latency and total sleep time. It is reasonable to assume that hospitalized children have disturbed sleep patterns prior to and following elective surgery. We hypothesize that melatonin will improve sleep patterns prior to and following surgery, by reducing sleep latency and extending total sleep time. We also hypothesize that this improvement will have positive impact on anesthetic stress measures and on recovery. The purposes of the study are: 1. To characterize sleep patterns in children undergoing surgery on the admission night prior to surgery; 2. To evaluate the effect of melatonin on sleep parameters on the night prior to surgery in children; 3. To evaluate the effect of melatonin on physiologic stress parameters during anesthesia and surgery in children; 4. To evaluate the effect of melatonin on sleep parameters of children postoperatively; 5. To evaluate the effect of melatonin on postoperative outcome measures in children. Patients, Methods. Ninety children (aged 4-18 years) will be evaluated. Sleep disorders will be screened by a pediatric sleep questionnaire. Sleep will be assessed by sleep logs and actigraphy for sleep onset time, sleep latency, total sleep time, total wake time, number and length of awakenings, sleep efficiency, sleep fragmentation index and sleep mean activity score. Recovery measures will include: length of hospitalization, infection rate, body temperature, cortisol levels, cooperation with medical staff. Study plan. The research will comprise of 5 consecutive steps. Step 1 will include the week prior to surgery and include sleep evaluation to all participants by sleep log and actigraphy. Step 2 is the night prior to surgery and will include sleep log and actigraphy. 30 children will receive melatonin (Circadin) 2mg, 30 children will receive placebo and 30 children will constitute the control group. Step 3 will be conducted during anesthesia and surgery where stress variables and need for anesthesia will be recorded. Step 4 will take place during post-operative hospitalization and will include actigraphy and sleep logs. Step 5 will take place at home two weeks after discharge and will include actigraphy and sleep logs.
The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.
The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD.
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
There is a well-documented relationship between short sleep duration and high body mass index (BMI). The mechanism linking short sleep duration and weight gain is unknown. Current studies in healthy young volunteers have shown that experimental sleep restriction is associated with dysregulation of the neuroendocrine control of appetite and with alterations in glucose metabolism. The goal of our study is to determine the metabolic and hormonal modifications induced by chronic sleep curtailment in obese adolescents and young adults and to observe if short sleep is a negative prognostic factor in their weight evolution.
The hypotheses of this study are: In the older population with knee OA, - When acupoints are chosen for both sleep and pain, there are additive effects on sleep improvement and pain relief (i.e. no interaction). - Main effects of acupuncture on sleep improvement and pain relief are anticipated when acupoints are separately targeted for sleep and for pain, respectively.
The investigators will examine whether sleep problems in children with autism spectrum disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that plays an important role in regulating sleep-wake cycle. Children with ASD experience high rates of sleep disturbances that potentially contribute to problems with thinking and behavior. It is unclear if changes in MT production cause sleep problems in children with ASD. MT is frequently used to treat these sleep problems; however, it has not been well established whether MT is an effective treatment. Our hypotheses concerning MT is children with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT production. This study will compare children diagnosed with ASD to "healthy" control children with no ASD diagnosis. All subjects will be recruited from one of three sites: Baylor College of Medicine, Oregon Health & Science University and Columbia University. The investigators will use a standardized questionnaire to determine whether the child has sleep problems. The investigators will measure MT levels in saliva in ASD children with sleep problems and in a group of control children without sleep problems. Total 24-hour MT production will be determined from urine samples in these same two groups.
The investigators hypothesize that in patients with shift work sleep disorder, armodafinil will specifically increase brain activity in the frontal cortex parallel with improvements in deficits of fundamental mechanisms of attention.
The purpose of this study is to determine the phase-advance in circadian rhythms in healthy adults subjects taking ramelteon, once daily (QD).