Objectives/Hypothesis:Previous feasibility studies have shown that electrical stimulation of the hypoglossal nerve can improve obstructive sleep apnea (OSA). The current study examined the safety and preliminary effectiveness of a second generation device, the Upper Airway Stimulation (UAS) system, and identified baseline predictors for therapy success.Study Design:Two consecutive open prospective studies.Methods:UAS systems were implanted in patients with moderate to severe OSA who failed or were intolerant of continuous positive airway pressure (CPAP). The study was conducted in 2 parts. In part 1, patients were enrolled with broad selection criteria. Apnea hypopnea index (AHI) was collected using laboratory‐based polysomnography at preimplant and postimplant visits. Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ) were also collected. In part 2, patients were enrolled using selection criteria derived from the experience in part 1.Results:In part 1, 20 of 22 enrolled patients (two exited the study) were examined for factors predictive of therapy response. Responders had both a body mass index ≤32 and AHI ≤50 (P < .05) and did not have complete concentric palatal collapse. Part 2 patients (n = 8) were selected using responder criteria and showed an improvement on AHI from baseline, from 38.9 ± 9.8 to 10.0 ± 11.0 (P < .01) at 6 months postimplant. Both ESS and FOSQ improved significantly in part 1 and 2 subjects.Conclusions:The current study has demonstrated that therapy with upper airway stimulation is safe and efficacious in a select group of patients with moderate to severe OSA who cannot or will not use CPAP as primary treatment. Laryngoscope, 2012
for the XP060 Study GroupObjective: To assess maintenance of efficacy and tolerability of gabapentin enacarbil in patients with moderate to severe primary restless legs syndrome (RLS). Patients and MethOds:This study (conducted April 18, 2006, to November 14, 2007) comprised a 24-week, single-blind (SB) treatment phase (gabapentin enacarbil, 1200 mg) followed by a 12-week randomized, double-blind (DB) phase. Responders from the SB phase (patients with improvements on the International Restless Legs Scale [IRLS] and investigator-rated Clinical Global Impression-Improvement scale at week 24 and stable while taking a gabapentin enacarbil dose of 1200 mg for at least 1 month before randomization) were randomized to gabapentin enacarbil, 1200 mg, or placebo once daily at 5 pm with food. The primary end point was the proportion of patients experiencing relapse (worse scores on the IRLS and investigator-rated Clinical Global Impression of Change scale on 2 consecutive visits at least 1 week apart or withdrawal because of lack of efficacy) during the DB phase.Results: A total of 221 of 327 patients completed the SB phase, 194 (96 in the gabapentin enacarbil group and 98 in the placebo group) were randomized to DB treatment, and 168 (84 in the gabapentin enacarbil group and 84 in the placebo group) completed the DB phase. A significantly smaller proportion of patients treated with gabapentin enacarbil (9/96 [9%]) experienced relapse compared with the placebo-treated patients (22/97 [23%]) (odds ratio, 0.353; 95% confidence interval, 0.2-0.8; P=.02). Somnolence and dizziness were the most common adverse events. One death occurred (unintentional choking during the SB phase) and was judged as being unrelated to the study drug. No clinically relevant changes were observed in laboratory values, in vital signs, or on electrocardiograms.cOnclusiOn: Gabapentin enacarbil, 1200 mg, maintained improvements in RLS symptoms compared with placebo and showed long-term tolerability in adults with moderate to severe primary RLS for up to 9 months of treatment. the study was funded by XenoPort inc, santa clara, ca. Research funding for the design and conduct of this study and the collection, management, analysis, and interpretation of the data were sponsored by XenoPort. Preparation, review, and approval of the submitted manuscript were sponsored by GlaxosmithKline, Research triangle Park, nc. dr bogan is a shareholder and employee of sleepMed; he has received consultancy fees from cephalon, GlaxosmithKline, and jazz Pharmaceuticals; has received research funding from actelion Pharmaceuticals, addrenex Pharmaceuticals, apnicure, arena Pharmaceuticals, boehringer ingelheim, cephalon, GlaxosmithKline, evotec, eli lilly and company, johnson & johnson, Merck & co, neurogen, Pfizer, novartis Pharmaceuticals, Philips, ResMed, sanofi-aventis, schwarz Pharma, sensory Medical, sepracor, vanda Pharmaceuticals, ventus Medical, and XenoPort; and has participated in speakers' bureaus for sanofi-aventis, sepracor, cephalon, and jazz Pharmaceuticals. ...
Rapid eye movement (REM) sleep behavior disorder (RBD) is characterized by loss of the muscle atonia of REM sleep, with release of complex and violent behaviors that are often attempted dream-enactments. This study reviewed the literature on RBD with regard to potentially lethal behavior. A total of 39-41 clinical cases of RBD associated with potentially lethal behaviors to self and/or others were found, involving a child and adults of all age groups, that manifested as choking/headlock (n = 22-24), defenestration/near-defenestration (n = 7), and diving from bed (n = 10). A total of 80.8% (n = 21) were males; 19.2% (n = 5) were females; mean age was 65.6 +/- (SD) 13.8 years (range: 27-81 years, and a child). (Gender/age data were not listed in the remaining cases.) An etiologic association of RBD with a neurologic disorder (or with pharmacotherapy of psychiatric disorders, n = 4) was present in 21-23 patients. Thus, RBD carries well-documented, potential forensic consequences during RBD episodes that could possibly have been misinterpreted as suicidal or homicidal behavior.
Sleep is clearly not only a whole-brain or global phenomenon, but can also be a local phenomenon. This accounts for the fact that the primary states of being (wakefulness, NREM sleep, and REM sleep) are not necessarily mutually exclusive, and components of these states may appear in various combinations, with fascinating clinical consequences. Examples include: sleep inertia, narcolepsy, sleep paralysis, lucid dreaming, REM sleep behavior disorder, sleepwalking, sleep terrors, out-of-body experiences, and reports of alien abduction. The incomplete declaration of state likewise has implications for consciousness - which also has fluid boundaries. Fluctuations in the degree of consciousness are likely explained by abnormalities of a "spatial and temporal binding rhythm" which normally results in a unified conscious experience. Dysfunctional binding may play a role in anesthetic states, autism, schizophrenia, and neurodegenerative disorders. Further study of the broad spectrum of dissociated states of sleep and wakefulness that are closely linked with states of consciousness and unconsciousness by basic neuroscientists, clinicians, and members of the legal profession will provide scientific, clinical and therapeutic insights, with forensic implications.
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