Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia.

Purpose: To report the efficacy and safety of lower-sodium oxybate (LXB; Xywav) during the open-label titration and optimization period (OLT) and stable-dose period (SDP) in a clinical study for the treatment of idiopathic hypersomnia.

Patients And Methods: Data were collected during treatment titration and optimization in a phase 3 randomized withdrawal trial in adults (18-75 years of age) with idiopathic hypersomnia who took LXB treatment (once, twice, or thrice nightly, administered orally) in the OLT (10-14 weeks), followed by the 2-week, open-label SDP. Endpoints included the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS), Patient Global Impression of Change, Clinical Global Impression of Change, Functional Outcomes of Sleep Questionnaire (FOSQ)-10, and Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP).

Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study.

Study Objectives: The clinical benefits of positive airway pressure (PAP) therapy for obstructive sleep apnea are assumed to require adherent PAP usage, defined by the Centers for Medicare & Medicaid Services as ≥ 4 hours of use ≥ 70% of nights. However, this definition is based on early data and does not necessarily capture improvements at subthreshold adherence. We explored dose-response relationships between PAP adherence measures and excessive daytime sleepiness from the HomePAP randomized controlled trial.

Clinical neurophysiology of NREM parasomnias.

The nonrapid eye movement (NREM) parasomnias range from age-related developmental phenomena in children to aggressive and injurious motor behaviors in all age groups. These parasomnias are commonly referred to as disorders of arousal and are an important cause of sleep-related injury. Genetic predisposition plays a role in the disorders of arousal, most evident in sleepwalking.

Polysomnography.

Polysomnography refers to a systematic process used to collect physiologic parameters during sleep. A polysomnogram (PSG) is a procedure that utilizes electroencephalogram, electro-oculogram, electromyogram, electrocardiogram, and pulse oximetry, as well as airflow and respiratory effort, to evaluate for underlying causes of sleep disturbances. PSG is considered to be the gold standard for diagnosing sleep-related breathing disorders, which include obstructive sleep apnea (OSA), central sleep apnea, and sleep-related hypoventilation/hypoxia.

A Pilot Study of a Sleep Intervention Delivered through Group Prenatal Care to Overweight and Obese Women.

Objectives: We sought to investigate the feasibility of a behavioral sleep intervention for insomnia, delivered through group prenatal care and the relationship of this intervention to improvements in insomnia symptoms and sleep quality.

Participants: Women receiving prenatal care and reporting a pre-pregnancy BMI of ≥25 kg/m and sleep duration of <6.5 h per night.

Reducing Coronary Heart Disease Risk Through Treatment of Insomnia Using Web-Based Cognitive Behavioral Therapy for Insomnia: A Methodological Approach.

: Observational data demonstrate increased risk of recurrent acute coronary syndrome in patients with comorbid insomnia. We conducted a pragmatic randomized controlled pilot study to address knowledge gaps and inform future large-scale randomized trials to test the impact of Web-based cognitive behavioral therapy for insomnia (wCBT-I) on coronary heart disease (CHD) outcomes. : Thirty-five adults recruited from Brigham and Women's and Cleveland Clinic Hospitals with insomnia, defined by Insomnia Severity Index (ISI) score ≥ 10 and symptoms of at least 3 months, and comorbid CHD identified from medical records.

Night Stepping: Fitbit Cracks the Case.

The most common sleep disorders that can result in injurious or violent behaviors include REM sleep behavioral disorder, sleepwalking, comorbid parasomnias, sleep-related dissociative disorder, and obstructive sleep apnea. Video polysomnography is usually indicated to evaluate recurring sleep-related injury in adults. Only one-third of patients with complex paroxysmal nocturnal events will have one of their habitual events on a single night of in-laboratory video polysomnography, most often those who have prominent, high-frequency motor features.

Epilepsy and Sleep-Related Breathing Disturbances.

Epilepsy is the fourth most common neurologic disorde in the United States, affecting over 2.2 million people. Epilepsy is associated with a number of medical and psychiatric comorbidities, higher health-care use and cost, and substantial economic burden.

Uvulopalatopharyngoplasty vs CN XII stimulation for treatment of obstructive sleep apnea: A single institution experience.

Objectives: Hypoglossal nerve stimulation (HNS) therapy is an emerging surgical treatment for select patients with obstructive sleep apnea (OSA). This study aims to compare outcomes in patients with moderate to severe OSA who underwent HNS surgery (Inspire Medical Systems) and those who underwent traditional airway reconstructive surgery, specifically uvulopalatopharyngoplasty (UPPP).

Methods: Patients who underwent HNS implantation (n = 20), all with moderate to severe OSA, inability to adhere to positive pressure therapy, and compliant with previously published inclusion criteria, were compared to a historical cohort that were intolerant of CPAP with similar inclusion criteria who all underwent UPPP (n = 20) with some also undergoing additional procedures such as septoplasty/turbinate reduction.

Wake up to sleep: The effects of lacosamide on daytime sleepiness in adults with epilepsy.

Objective: The objective of the study was to investigate the effects of lacosamide (LCM) on daytime sleepiness ascertained by the Epworth Sleepiness Scale (ESS) in adults with focal epilepsy in a randomized, controlled design.

Methods: Subjects taking ≤2 AEDs for ≥4weeks underwent polysomnography with EEG followed by the maintenance of wakefulness test (MWT) and completed the ESS and other patient-reported outcomes (PROs) at baseline, LCM 200mg/day, and LCM 400mg/day (Visit 4; V4). Primary endpoint was ESS change (V4 to baseline) between LCM and placebo.

Polysomnography results in pediatric patients with mild obstructive sleep apnea: Adenotonsillectomy vs. watchful waiting.

Objective: There is a lack of consensus and a paucity of data regarding how to best treat pediatric patients with mild obstructive sleep apnea. The objective of our study was to compare outcomes following adenotonsillectomy vs. observation in children with mild obstructive sleep apnea based on polysomnography results.

Neck Circumference-Height Ratio as a Predictor of Sleep Related Breathing Disorder in Children and Adults.

Study Objectives: While neck circumference (NC) is a useful predictor of obstructive sleep apnea (OSA) in adults, childhood OSA is difficult to predict clinically. We utilized the neck circumference-height ratio (NHR) to normalize NC in growing children. Our study aimed to determine if (1) NC is a reproducible clinical measurement; (2) NHR predicts OSA in children; (3) this metric translates to adults.

Prevalence of Undetected Sleep Apnea in Patients Undergoing Cardiovascular Surgery and Impact on Postoperative Outcomes.

Study Objective: We examined the prevalence of obstructive sleep apnea (OSA) among patients undergoing cardiac surgery and its impact on postoperative outcomes.

Methods: Subjects were recruited from inpatient cardiovascular surgery units at two tertiary care centers. Crystal Monitor 20-H recorded polysomnograms preoperatively.

Caffeine Awareness in Children: Insights from a Pilot Study.

Study Objectives: Caffeine, a commonly consumed psychoactive substance, can have significant effects on sleep. Caffeine intake among children is increasing, mainly in the form of sodas. However, adolescent caffeine consumers may lack knowledge about the caffeine content in common beverages.

Use of the Sleep Apnea Scale of the Sleep Disorders Questionnaire (SA-SDQ) in adults with epilepsy.

Objective: A growing body of literature supports the importance of sleep comorbidities in epilepsy. The prevalence of obstructive sleep apnea (OSA) in adults with epilepsy exceeds that of the general population, and its presence adversely impacts seizure control in some cases. The Sleep Apnea Scale of the Sleep Disorders Questionnaire (SA-SDQ) is a 12-item screening instrument generally used in clinical research.

Sleep disorders in pregnancy: implications, evaluation, and treatment.

The dynamic changes across pregnancy affect sleep and wakefulness producing sleep disturbances, which causes sleep disorders in some cases. This review will identify common sleep disorders in pregnancy, related maternal-fetal outcomes, pathophysiologic mechanisms, and potential therapies to guide clinicians in serving this population.

Association of plasma homocysteine with self-reported sleep apnea is confounded by age: results from the national health and nutrition examination survey 2005-2006.

High levels of plasma homocysteine are implicated in the pathogenesis of cardiovascular diseases especially if accompanied by sleep apnea, but a direct pathogenetic link between plasma homocysteine levels and obstructive sleep apnea is debatable. This association can have far-reaching public health implications considering the inverse association between folate and plasma homocysteine. We used data from the 2005-2006 cycle of the National Health and Nutrition Examination Survey (NHANES) to test the hypothesized associations.

Sleep and epilepsy.

Over a century of work has confirmed crucial links between sleep and epilepsy. Seizures and some antiepileptic drugs (AEDs) adversely affect the continuity of sleep. However, sleep is fragmented in the absence of seizures or medication, suggesting that sleep instability may be an inherent component of certain forms of epilepsy.

Sleep-related breathing disorders in patients with idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis (IPF) is a chronic and usually fatal lung disease of unknown etiology. The aim of this study was to describe clinical and polysomnographic features of sleep-related breathing disorders (SRBD) and to identify predictors of obstructive sleep apnea (OSA) in IPF patients. Eight hundred fifty-seven patients with IPF were admitted to the Cleveland Clinic from 2001 to 2005.

Health-related quality of life in patients with obstructive sleep apnoea and chronic obstructive pulmonary disease (overlap syndrome).

The association of obstructive sleep apnoea (OSA) and chronic obstructive pulmonary disease (COPD) is not rare as COPD and OSA are both frequent diseases. The aim of this study was to determine the effect of OSA on quality of life (QOL) in patients with overlap syndrome (OVS). Thirty subjects with OVS and 15 control subjects participated.