View clinical trials related to Restless Legs Syndrome.
Filter by:The primary objective of the study is to determine whether Butrans Transdermal System (BTDS) reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are naïve to opiate treatment. The secondary objective of the study is to investigate the effects of BTDS on mood, sleep, and quality of life. The study will consist of nine visits. Depending on the need for medication titration, there may also be two scheduled telephone contacts. Visit 1: This is a screening visit to determine study eligibility. Eligible subjects who choose to participate must undergo medication washout as described in the detailed protocol between visits 1 and 2. Treatment period #1 (Visits 2 - 5; day 0 - 28): Baseline measures will be recorded and subjects randomized to treatment order at visit 2 (day 0). Study medication as well as rescue medication (l-dopa, a non-blinded active treatment to be used within a limited dose range as described in the detailed protocol) will be dispensed. Subjects will begin treatment period #1 immediately after this. The study medication will be titrated within the allowed range according to subject's reported symptoms during visit 3 (day 7), visit 4 (day 14), telephone contact (day 21). Visit 5 will occur on day 28 and will include assessment of outcome measures for the first treatment period. Visit 5 will also mark the beginning of the second treatment period. Treatment period #2 (Visits 6 - 8; day 28 - 56): Procedures will be similar to those described above during treatment period #1. Visit 8 will mark the end of the second treatment period during which outcome measures will be ascertained. Follow up visit (Visit 9; day 70): This will be a safety follow-up visit approximately two weeks after visit 8 for review of adverse events.
The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.
Objective: Obstructive sleep apnoea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB) causing sleep fragmentation, daytime sleepiness, cognitive function impairment, and poor health status in addition to increased risk of cardiovascular complications. OSAS is equally common among the middle-aged male Caucasian and Hong Kong (HK) Chinese populations with a prevalence of at least 4%. However, the prevalence of OSAS in the elderly population in Asia including HK is unknown. Study Design: A sleep questionnaire will be conducted for 1000 subjects aged at least 60 yrs in the elderly community centers focusing on symptoms of OSAS, subjective sleepiness, restless leg syndrome, and sleep-related habits and routines, in addition to past medical history and medications. Home sleep study (EMBLETTA) capable of recording sleep (a single EEG channel), respiratory events, snoring, respiratory efforts and oximetry will be performed on 300 subjects randomly. Those who have negative or technical inadequate EMBLETTA study with a high pre-test probability of moderate to severe OSA will be invited to undergo hospital-based polysomnography for confirmation of their sleep apnoea status. Subjects with AHI>15/hr regardless of symptoms or those with AHI 5-15/hr plus comorbid conditions or excessive daytime sleepiness will be offered continuous positive airway pressure (CPAP) titration followed by CPAP treatment, with serial assessment of subjective sleepiness, quality of life, and cognitive function. Outcome measures: the prevalence rates of SDB (AHI>10, >15 and >30/hr), OSAS, and other sleep disturbances, such as restless leg syndrome (RLS). In addition, we will examine the factors which are predictive of the presence of SDB in this population, and assess the CPAP acceptance, compliance, and treatment outcome of those with OSAS.
The purpose of this study is to explore whether patients with restless legs syndrome (RLS) differ from healthy subjects in daytime and night time autonomic function and cardiovascular risk markers and whether 4 week treatment with pramipexole affects autonomic function and cardiovascular risk markers in patients with RLS.
Hypothesis:Sleep Disorders are very common during pregnancy but the their exact role in causation of pregnancy related disorders is yet to be determined. OSA can complicate pregnancy given the risk factors of weight gain, upper displacement of the diaphragm, and hormonal-induced hyperaemia of the nasopharyngeal passages. SDB confers the risk of hypertensive disorders of pregnancy and is associated with adverse maternal and foetal outcomes. The study would involve pregnant females which would be prospectively followed in pregnancy and post partum to know the prevalence of sleep disorders in pregnancy. Diagnosis of sleep disorders would be confirmed by overnight polysomnography and ambulatory blood pressure monitoring. Pregnancy outcomes, both maternal and fetal would be recorded and its relation with sleep disorders in pregnancy would be analysed.
Restless Leg Syndrome (RLS) is a common neuropathic disorder in patients with end stage renal disease (ESRD). Study Design: Because micronutrient depletion has been associated with RLS in ESRD and because the vitamin biotin is dialyzable, the investigators examined the relationship between biotin status and RLS in ESRD. Objectives: To assess the prevalence of biotin deficiency in those with and without RLS (Study 1) and to determine the effect of biotin supplementation on RLS symptoms (Study 2) in patients receiving chronic dialysis due to ESRD.
Firefighters work some of the most demanding schedules known under highly stressful and demanding conditions. The need to work frequent extended shifts and long work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of circadian phase. Sleep disorders are common, costly, and treatable, but often remain undiagnosed and untreated and it is likely that a significant proportion of firefighters suffer from undiagnosed sleep disorders which will further impair their sleep and exacerbate fatigue.In the current proposal, we aim to address the health, performance and safety issues related to fatigue in firefighters and test the effectiveness of a Comprehensive Firefighter Fatigue Management Program (CFFMP) that we have termed 'Operation Healthy Sleep.'
To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.
The primary objective is to demonstrate safety and tolerability of switching patients with Restless Legs Syndrome (RLS) from an oral dopamine agonist to rotigotine. As a secondary objective, the investigators will evaluate control of RLS symptoms on rotigotine compared to the prior oral regimen.
Our study aimed to examine a possible association between Restless legs syndrome and cerebrovascular disease, by examining patients during hospitalization for acute stroke or transient ischemic attack, in a matched case-control design.