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Periodic Limb Movement

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3121. Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)

Date : April 2004 Study Completion Date : April 2004 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG). [ Time Frame: 3 weeks ] Secondary Outcome Measures : Secondary outcomes of the study were other PSG-derived endpoints (changes in the RLS symptom rating scale (RLSRS

2005 Clinical Trials

3122. Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period. Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10. INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use (...) either arm for any purposeful movement. INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help Secondary Outcome Measures : Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period [ Time Frame: 6 months ] Mean changes in amplitude [mV] measured at most proximal site in the most severely affected motor nerve from baseline to endpoint during the Efficacy Period (Intent

2005 Clinical Trials

3123. Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome

by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : The average number of periodic leg movements during three consecutive nights of actigraphy beginning at the end of the double blind phase Secondary Outcome Measures : Proportion of time in bed without leg movements during the three consecutive nights of actigraphy beginning at the end of the double blind phase SF-36 at the last visit of the double (...) blind phase Score on the RLS Rating Scale (modified) questionnaire at the last visit of the double blind phase Periodic leg movements during sleep and wakefulness during the PSG recorded at the end of the double blind phase PSG measures including periodic leg movement arousal index, latency until sustained sleep, sleep efficacy, and wake after sleep onset Sleep diaries at the last double-blind visit Epworth sleepiness scale at the last double-blind visit Eligibility Criteria Go to Information from

2005 Clinical Trials

3124. Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects

to keep the study routine). Presence of a sleep problem revealed that may explain the subjects' complaints, such as sleep disordered breathing, restless leg syndrome or periodic limb movement syndrome. Use of benzodiazepines or other hypnotics during the study and preceding two weeks or 5 half lives whichever is longer. Known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists Use of melatonin during preceding two weeks Use of psychiatric medications during the study (...) : placebo Phase 2 Detailed Description: This was a multi-center, double-blind, placebo-controlled study of a once-daily (QD) dose of Circadin™ 2 mg in subjects with non-24 hour sleep-wake disorder. Subjects were initially treated with placebo for 2 weeks and then were randomly assigned in a 1:1 ratio to receive Circadin™ 2 mg or placebo for 6 weeks, followed by a 2-week washout period. The primary objective was to assess the effect of Circadin 2 mg given once daily for 6 weeks on total night sleep

2009 Clinical Trials

3125. Stability and 3D Motion Study of an Experimental Prosthetic Foot

topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Congenital/Traumatic Individuals who were born with a limb deficiency or who have had a traumatic amputation. Device: Experimental prosthetics foot (K3 Promoter) The tests will be unblinded randomized studies of the subject's current prosthetic foot and the K3 Promoter on traumatic/congenital amputees and dysvascular/diabetic amputees. Assessments will be made after a 30-day accommodation period with each foot prosthesis (...) amputee gait and movement in the CGMA's state-of-the-art facility the investigators will expand these studies with BRDG-SPAN funding by studying the following metrics: Four Square Step Test (FSST) Amputee Mobility Predictor (AMP) Timed Up and Go Test (TUG) Quality of life (QOL) index (SF-36) Activity-specific Balance Confidence Questionnaire (ABC) 3D motion analysis Condition or disease Intervention/treatment Phase Amputation Device: Experimental prosthetics foot (K3 Promoter) Phase 3 Detailed

2009 Clinical Trials

3126. Pilot Study of Melatonin and Epilepsy

outside of a room with closed door Combined score of 30 or more on sleep fragmentation, parasomnia and daytime drowsiness subscales on SBQ. Exclusion Criteria: History of significant snoring- loud snoring every night heard outside of a room with closed door Diagnosis of obstructive sleep apnea (OSA) or periodic limb movement disorder on PSG Vagus nerve stimulator implanted History of a major psychiatric disease (e.g. psychosis, major depression) History of autism or pervasive development disorder

2009 Clinical Trials

3127. Oral Appliance Therapy in Obstructive Sleep Apnea

, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: age > 18 years apnea-hypopnea index (AHI) between 5 and 45 events per hour Exclusion Criteria: evidence of respiratory/ sleep disorders other than obstructive sleep apnea a body mass index (BMI) > 40 medication usage that could influence respiration or sleep periodic limb movement disorder previous treatment

2009 Clinical Trials

3128. Young Adult and Teen Sleep Study

from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep. Mental retardation, autism spectrum disorder, or other significantly impairing pervasive developmental disorder. Sleep treatment that might confound the interpretation of sleep outcomes. Any non-insomnia, non-depressive disorder if the other comorbid condition is clearly the most severe and most impairing of all current diagnoses, and if there is a significant risk of harm (...) . Clarke and Harvey. We are conducting this small RCT at both sites is to establish the feasibility of conducting a fully-powered RCT at multiple sites to be funded by a later, separate R01 application.. Our goal is to enroll 20-30 cases at each of the two sites, for a total of up to 60 youth (30 per study condition). We propose to enroll this modest sample over a 12 month recruitment period. We expect facilitated referrals from several sources, different at each site. In Portland recruitment

2009 Clinical Trials

3129. Sensori-motor Integration Training in Multiple Sclerosis

to a randomization design. The experimental group will undergo a specific training program aimed at increasing balance ability in several sensory conflict conditions. The training program will consist of fifteen 50-minute sessions over a 5 week period (3 sessions/week). The control group will undergo conventional neurorehabilitation treatment following the same pattern of sessions as the study group. At recruitment, after treatment (5 weeks) and in the follow-up (1 month), each patient will be tested (...) Integration Training Procedure: Sensory-motor Integration Training Exercises will be divided into 3 levels. 1 Starting from the patient's most stable and comfortable standing position. 2 Patient will perform a single-step simulation, shifting his/her weight from one foot to the other in a frontal direction. 3 Patient will perform rapid movements, alternating feet in many directions, progressively increasing weight shifting and decreasing the support base amplitude. In the first five sessions exercises

2009 Clinical Trials

3130. Sleep Disturbance and Bipolar Disorder

apnea, restless legs syndrome or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome) Patients who pose a current suicidal risk or homicidal risk (assessed by treating psychiatrist) or who have made a suicide attempt within the past 6 months. Pharmacotherapy for sleep defined as the benzodiazepine and non-benzodiazepine hypnotics that operate via the GABA A receptor complex and are FDA approved for the treatment of insomnia

2009 Clinical Trials

3131. Extension of the MIME Robotic System for Stroke Rehabilitation

by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs ) Study Details Study Description Go to Brief Summary: The goal of this project is to develop and test a new robotic system to accommodate practice of tasks requiring reach, grasp and release of objects. Our previous work has shown that the MIME robot is safe and effective for improving reach in stroke subjects. But adequate control of hand movements is critical to a functional upper limb, and is often resistant (...) to assist hand movement. Since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. This exoskeleton will be integrated with the ARMin III arm exoskeleton so that tasks such as arm reach, grasp of an object and release of the object can be trained. In the last 2 years of the project, we will perform a pilot

2009 Clinical Trials

3132. Individual Differences in Diabetes Risk: Role of Sleep Disturbances

bedtimes between 7.0-8.5 hours, and do not take medications will be recruited. An overnight polysomnography will be performed to rule out sleep-disordered breathing (apnea-hypopnea index > 5/hour) and periodic limb movement disorder (PLM arousal index >1/hour). Women taking hormonal contraceptive therapy and pregnant women will be excluded. In women, all studies will be initiated in the early follicular phase. Exclusion Criteria: Tobacco use. Habitual alcohol use of more than 2 1 drink per day

2009 Clinical Trials

3133. Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance

. Secondary Outcome Measures : Periodic Limb Movement Arousal Index (PLMAI) [ Time Frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET ] PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time [TST]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model. Subjective Total Sleep Time (sTST) [ Time Frame (...) -14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model. Periodic Limb Movement Index (PLMI) [ Time Frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET ] PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB

2009 Clinical Trials

3134. An Exploratory Study of a Nasal Dilator Strip

, narcolepsy, or periodic limb movement disorder). Subject has a non-typical sleep schedule (e.g. shift-work). Subject plans travel involving time-zone changes during the study period. Subject takes medication known to have a significant effect on sleep. Use of any substance with psychotropic effects or properties known to affect sleep/wake, including but not limited to: neuroleptics, morphine/opioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, barbiturates, anxiolytics (...) : Screening phase, Baseline phase, 28 days Active phase (1 month in home treatment usage period with sleep laboratory nights after 7 (Night 8) and 28 days (Night 29) of treatment) followed by a two-night cross-over Nasal resistance phase. Screened participants were evaluated for sleep disordered breathing and PSG variables with sleep laboratory nights at Baseline, after 7 and 28 days of in house use of nasal dilator strip (Night 8 and 29 of Active phase), at Day 29 and 30 (Night 30 and 31 of Nasal

2009 Clinical Trials

3135. Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome

Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion criteria: Patients with high probability of OSA, defined by two or more of : daytime sleepiness snoring recognized apnoeic episodes associating obesity and / or hypertension Exclusion Criteria: Patients with impaired lung function ( overlap syndrome, obesity-hypoventilation syndrome, restrictive disorders), associated pathology (psychiatric disorder, periodic limb movements, dyssomnias or other

2009 Clinical Trials

3136. A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia

syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic Patients with circadian rhythm sleep disorder Patient works night shifts Patients with alcoholic sleep disorder Patients with alcohol or drug dependence or a history of these Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs Patients with sleep apnea syndrome Patients with restless legs syndrome or periodic limb movement disorder Patients with epileptic insomnia Patients smoke (...) : Zolpidem oral Other Name: Myslee Outcome Measures Go to Primary Outcome Measures : Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings) [ Time Frame: 8 hours ] Secondary Outcome Measures : Mean sleep parameters estimated from polysomnography recording [ Time Frame: 8 hours ] Sleep parameters estimated from sleep questionnaire [ Time Frame: After each night of sleep during the study period ] Patient impression from sleep questionnaire [ Time

2009 Clinical Trials

3137. Botulinum Toxin Type A and Kinesitherapy of Post-stroke Patients

. Demographical data will be collected by a questionnaire, the range of movement will be measured with a goniometer, and the muscle tone will be determine by the modified Ashworth scale, with the patient in dorsal decubitus. The presence of hypertonia equal or superior to 2 will assign the respective muscle to injection. Then the patients will be conducted to another room, where another therapist will assess the functional performance by the "timed up and go" (TUG) test, a six-minutes duration walking (...) , and the Fugl-Meyer scale for the upper limb, with the patient in the seated position. During the TUG test the patient is asked to stand up from a chair and walk 3 meters, turn around 180 degrees, and walk back to the chair, assuming 10 seconds as the normal. The 6 minutes walking test will measure the distance in meters in a previously demarcated place. A staff will constantly stimulate the patient verbally, to walk as fast as possible. Posteriorly the patients will be set in another room, where

2009 Clinical Trials

3138. Mild Hypothermia in Acute Ischemic Stroke

significant neurological deficit (NIHSS 7-20 or NIHSS 2 for dysphasia or NIHSS 3 for paralysis of upper or lower limb) at 2 hours after thrombolysis. Method: Patients are randomized to hypothermia- or control-group via randomization envelopes. Patients assigned to receive hypothermia are cooled to a core temperature of 35°C for 12 hours by means of a non-invasive temperature management system and cold i.v. fluids. Induction of hypothermia is initiated within 6 hours of symptom onset. After 12 hours (...) No Intervention: Control Outcome Measures Go to Primary Outcome Measures : The proportion of patients maintaining temperature below 36.0°C 80% of the 12-hour hypothermia period. [ Time Frame: 12 hours ] Secondary Outcome Measures : The incidence of intracerebral hemorrhage, infections, hemodynamically significant cardiac arrhythmias, severe disturbance of electrolytes and fluid balance, thrombocytopenia, and serious adverse events [ Time Frame: 14 days ] All-cause mortality during acute phase (7 days), 1

2009 Clinical Trials

3139. Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

of Periodic Limb Movement Disorder or Restless Legs Syndrome Severe Chronic Obstructive Pulmonary Disease Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048242 Locations Layout table for location information United States, Pennsylvania University

2009 Clinical Trials

3140. Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure (CPAP)

. Surgery of the upper airway, nose, sinus or middle ear within the past 90 days Currently using supplemental oxygen Regular use of sleeping pills or stimulants (> 3 nights a week) Currently working night shift or rotating day/night shift Drowsy Driving or near miss accident in the past 6 months Inability to tolerate or track to Paced Breathing device during initial habituation session in lab Chronic insomnia, Restless legs syndrome, or severe periodic limb movement disorder (PLMD - PLMAI>20/hr (...) the subject is wearing the device during the sleep study, an average of 08 hours. ] We tested the ability of the Sleep/Wake algorithm to identify sleep an wake periods with precision, as compared to standard polysonography (PSG) measures, which was used as the gold standard, i.e. we tested the accuracy of the algorithm. Accuracy was defined as the proportion of true results (both true positives and true negatives)in the population and it was assesed using as 2 X 2 table, i.e. accuracy = number of true

2009 Clinical Trials

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