A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome.

Study Objective: To evaluate the efficacy and tolerability of XP13512/ GSK1838262, an investigational nondopaminergic agent for the treatment of moderate-to-severe primary restless legs syndrome (RLS).

Design: Randomized, double-blind, placebo-controlled, crossover trial.

Setting: Nine US clinical sites.

Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS.

Objective: To assess the efficacy and tolerability of the nondopaminergic agent XP13512/GSK1838262 in adults with moderate to severe primary restless legs syndrome (RLS).

Methods: Patient Improvements in Vital Outcomes following Treatment in Restless Legs Syndrome I was a 12-week, multicenter, randomized, double-blind, placebo-controlled trial of XP13512 1,200 mg or placebo taken once daily at 5:00 pm with food. Coprimary endpoints were mean change from baseline International Restless Legs Scale (IRLS) total score and proportion of investigator-rated responders (very much improved or much improved on the Clinical Global Impression-Improvement scale) at week 12 (last observation carried forward).

Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea.

Positive airway pressure (PAP) devices are used to treat patients with sleep related breathing disorders (SRBDs), including obstructive sleep apnea (OSA). After a patient is diagnosed with OSA, the current standard of practice involves performing attended polysomnography (PSG), during which positive airway pressure is adjusted throughout the recording period to determine the optimal pressure for maintaining upper airway patency. Continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BPAP) represent the two forms of PAP that are manually titrated during PSG to determine the single fixed pressure of CPAP or the fixed inspiratory and expiratory positive airway pressures (IPAP and EPAP, respectively) of BPAP for subsequent nightly usage.

The use of esophageal manometry in the diagnosis of sleep-related breathing disorders.

Esophageal manometry is a technique used to detect abnormal sleep-related respiratory events. One method used to measure and score esophageal pressure during sleep is described. The contraindications for esophageal manometry, the methods for scoring esophageal pressure, the use of esophageal manometry as the "gold standard", and directions for future research are discussed.

Clinical presentation, diagnosis, and quality of life issues in restless legs syndrome.

Restless legs syndrome (RLS) is a generally underdiagnosed and undertreated condition. It is a common cause of sleep disturbance that can severely disrupt normal life functioning. However, because of the failure to recognize RLS as a distinct disorder, clinicians have minimized the significance of the morbidity experienced by some patients.

Ropinirole for the treatment of restless legs syndrome.

Dopaminergic agents, anticonvulsants, benzodiazepines, opiates, and iron supplementation comprise the classes of medications commonly used to treat restless legs syndrome (RLS), which is a disorder that is estimated to affect about 1 in 10 individuals worldwide and impacts an affected patient's sleep, mood, daytime function, and quality of life. RLS is characterized by an urge to move the legs that is worse at bedtime and at rest; the symptoms are temporarily relieved by leg movement. It is frequently accompanied by periodic limb movements during sleep (PLMS), which may independently disrupt sleep and may cause daytime drowsiness.

Countermeasures for sleep loss and deprivation.

Sleep deprivation is ubiquitous and carries profound consequences in terms of personal and public health and safety. There is no substitute for a good night's sleep. Sleep that is optimal in quality and quantity for individuals, factoring in their age and personal sleep requirements, will minimize sleep debt and maximize daytime performance.

Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders.

Positive airway pressure (PAP) devices are used to treat patients with sleep related breathing disorders (SRBD) including obstructive sleep apnea (OSA). Currently, PAP devices come in three forms: (1) continuous positive airway pressure (CPAP), (2) bilevel positive airway pressure (BPAP), and (3) automatic self-adjusting positive airway pressure (APAP). After a patient is diagnosed with OSA, the current standard of practice involves performing full, attended polysomnography during which positive pressure is adjusted to determine optimal pressure for maintaining airway patency.

Pramipexole for the treatment of restless legs syndrome.

Restless legs syndrome (RLS) is a common disorder that is estimated to affect 10% of Americans. However, it remains largely undiagnosed and untreated by clinicians. The primary symptoms of this condition are leg discomfort or an urge to move that is temporarily relieved by movement and is worse at rest and at bedtime.

Practice parameters for the treatment of snoring and Obstructive Sleep Apnea with oral appliances: an update for 2005.

These practice parameters are an update of the previously published recommendations regarding use of oral appliances in the treatment of snoring and Obstructive Sleep Apnea (OSA). Oral appliances (OAs) are indicated for use in patients with mild to moderate OSA who prefer them to continuous positive airway pressure (CPAP) therapy, or who do not respond to, are not appropriate candidates for, or who fail treatment attempts with CPAP. Until there is higher quality evidence to suggest efficacy, CPAP is indicated whenever possible for patients with severe OSA before considering OAs.

Practice parameters for the indications for polysomnography and related procedures: an update for 2005.

These practice parameters are an update of the previously-published recommendations regarding the indications for polysomnography and related procedures in the diagnosis of sleep disorders. Diagnostic categories include the following: sleep related breathing disorders, other respiratory disorders, narcolepsy, parasomnias, sleep related seizure disorders, restless legs syndrome, periodic limb movement sleep disorder, depression with insomnia, and circadian rhythm sleep disorders. Polysomnography is routinely indicated for the diagnosis of sleep related breathing disorders; for continuous positive airway pressure (CPAP) titration in patients with sleep related breathing disorders; for the assessment of treatment results in some cases; with a multiple sleep latency test in the evaluation of suspected narcolepsy; in evaluating sleep related behaviors that are violent or otherwise potentially injurious to the patient or others; and in certain atypical or unusual parasomnias.

Ropinirole in the treatment of restless legs syndrome.

Ropinirole is an original nonergoline dopamine agonist indicated for the treatment of Parkinson's disease. However, recent developments in the study of restless legs syndrome have demonstrated another role for this drug. The symptoms of restless legs syndrome are responsive to dopaminergic agents such as ropinirole.

Modeling the causal relationships between symptoms associated with restless legs syndrome and the patient-reported impact of RLS.

The objective of this study is to examine the causal relationships between the symptoms of restless legs syndrome (RLS) and specific clinical and subjective health-related, quality of life consequences. Structural equation modeling was applied to data from a questionnaire-based observational study. The RLS morbidities of decreased functional alertness and emotional distress in our sample of patients appear to be mostly secondary to the sleep disturbance associated with RLS.

Comparison of actigraphic, polysomnographic, and subjective assessment of sleep parameters in sleep-disordered patients.

Objective: Comparison of polysomnography (PSG)-derived sleep parameters (total sleep time, sleep efficiency, and number of awakenings) to those derived from actigraphy and subjective questionnaires.

Background: Actigraphy is commonly used to assist sleep specialists in the diagnosis of various sleep and circadian-rhythm disorders. However, few validation studies incorporate large sample sizes, typical sleep clinic patients, or comparisons with subjective reports of sleep parameters.

Technical protocol for the use of esophageal manometry in the diagnosis of sleep-related breathing disorders.

A time-tested protocol for intrathoracic pressure monitoring during sleep is described. This method of esophageal manometry uses a fluid-filled catheter to measure variations in transmitted intrathoracic pressure with respiration. Esophageal manometry is an invaluable tool for the sleep specialist in the diagnosis of sleep-related breathing disorders, especially for detecting cases of upper airway resistance syndrome and for distinguishing subtle central apneas from obstructive events.

Restless legs syndrome symptoms in primary care: a prevalence study.

Background: There are relatively few studies on the prevalence of restless legs syndrome (RLS) in the general population, even fewer that used diagnostic questions covering all 4 essential diagnostic criteria defining the RLS symptom complex, and none that have reported on the 2 RLS phenotypes for patients seen by family physicians.

Methods: To determine the prevalence of the symptom complex, diagnostic for RLS in a primary care patient population, a prospective population-based single-center study was performed. Every adult patient presenting for care in a small rural primary care practice with mostly white patients was surveyed for a 1-year period using a validated RLS diagnostic questionnaire.

Nasal obstruction in sleep-disordered breathing.

It has been 30 years since Cottle suggested that "sleeping patterns are in great measure dependent on good nasal function" [1]. During this time, we have identified the OSAHS and related forms of sleep-disordered breathing such as UARS, and better appreciate the clinical sequelae of recurrent arousals and sleep fragmentation. Yet the exact role that obstructed nasal breathing plays in the pathogenesis of such sleep disorders remains presumptive, and robust clinical studies to corroborate this theory remain elusive; however, patients who may benefit most from correction of nasal obstruction as a sole intervention may be those with the mildest forms of sleep-disordered breathing without other significant predisposing anatomic abnormalities.

Sites of obstruction in obstructive sleep apnea.

Study Objective: The aim of this article was to identify the most common sites of obstruction in patients with obstructive sleep apnea (OSA) by a systematic review of published studies.

Design: The review was conducted by a MEDLINE search of the English literature published during the years 1980 to 2002. The inclusion criteria were experiments involving five or more adult subjects, total rather than partial obstruction or narrowing of the upper airway, and techniques that were performed on the subjects while they were asleep.

Symptom-Based Prevalence of Sleep Disorders in an Adult Primary Care Population.

The prevalence of sleep disorders in a primary care physician practice in Moscow, Idaho, was studied between February 7, 1997, and February 6, 1998. This primary care clinic visit population was surveyed for this 1-year period. Every patient above the age of 18 years who visited the Moscow Clinic in this time period was either approached by our on-site researcher during the patient's clinic visit or contacted via mail.