Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine
-
Randomized Controlled Trial Multicenter Study
Diagnosis and Treatment of Sleep Apnea in patients' homes: the rationale and methods of the "GoToSleep" randomized-controlled trial.
The "Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease" (GoToSleep) study is evaluating a strategy to improve the diagnosis and treatment of sleep apnea among veterans with stroke or transient ischemic attack (TIA) who also have hypertension. Specifically, the GoToSleep study was designed to overcome some of the barriers that exist within the Veterans Health Administration (VHA) to the timely diagnosis and treatment of sleep apnea by using ambulatory home-based polysomnography and auto-titrating continuous positive airway pressure (CPAP) to reduce the reliance on laboratory-based sleep studies. ⋯ This manuscript provides the rationale for 4 key components of the design of the GoToSleep trial: the inclusion of patients with cerebrovascular disease and hypertension without the use of a measure of daytime sleepiness as an eligibility criterion; the use of portable polysomnography and auto-titrating CPAP in patients' homes rather than using sleep laboratory polysomnography with fixed pressure CPAP; the analytic approach to evaluating change in blood pressure in the context of change in antihypertensive medications; and the use of a usual care control group.
-
Randomized Controlled Trial
Randomized, double-blind clinical trial of two different modes of positive airway pressure therapy on adherence and efficacy in children.
To determine the effects of bilevel positive airway pressure with pressure release technology (Bi-Flex) on adherence and efficacy in children and adolescents compared to standard continuous positive airway pressure (CPAP) therapy. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP. ⋯ Both CPAP and Bi-Flex are efficacious in treating children and adolescents with OSAS. However, adherence is suboptimal with both methods. Further research is required to determine ways to improve adherence in the pediatric population.
-
Randomized Controlled Trial Multicenter Study
Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).
Evaluate the long-term durability of treatment response and safety of a nasal expiratory positive airway pressure (EPAP) device used to treat obstructive sleep apnea (OSA). ⋯ NCT00849043.
-
Randomized Controlled Trial Comparative Study
Accurate position monitoring and improved supine-dependent obstructive sleep apnea with a new position recording and supine avoidance device.
Approximately 30% of obstructive sleep apnea (OSA) patients have supine-predominant OSA, and simply avoiding supine sleep should normalise respiratory disturbance event rates. However, traditional supine-avoidance therapies are inherently uncomfortable, and treatment adherence is poor and difficult to monitor objectively. This study evaluated the efficacy of a novel, potentially more acceptable position monitor and supine-avoidance device for managing supine-predominant OSA and snoring. ⋯ This new position monitoring and supine alarm device records sleep position accurately and improves OSA but not snoring in patients with supine-predominant OSA.
-
Randomized Controlled Trial Multicenter Study
A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome.
To evaluate the efficacy and tolerability of gabapentin enacarbil (GEn) 1200 mg or 600 mg compared with placebo in subjects with moderate-to-severe primary restless legs syndrome (RLS). ⋯ GEn 1200 mg and 600 mg significantly improve RLS symptoms and sleep disturbance compared with placebo and are generally well tolerated.