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Wilt T.J.,Minneapolis Veterans Affairs Health Care System | MacDonald R.,Minneapolis Veterans Affairs Health Care System | Olson C.M.,Minneapolis Veterans Affairs Health Care System | Carlyle M.,Optum Inc | And 4 more authors.
Annals of Internal Medicine | Year: 2016

Background: Pharmacologic interventions are often prescribed for insomnia disorder. Purpose: To assess the benefits, harms, and comparative effectiveness of pharmacologic treatments for adults with insomnia disorder. Data Sources: Several electronic databases (2004-September 2015), reference lists, and U.S. Food and Drug Administration (FDA) documents. Study Selection: 35 randomized, controlled trials of at least 4 weeks' duration that evaluated pharmacotherapies available in the United States and that reported global or sleep outcomes; 11 long-term observational studies that reported harm information; FDA review data for nonbenzodiazepine hypnotics and orexin receptor antagonists; and product labels for all agents. Data Extraction: Data extraction by single investigator confirmed by a second reviewer; dual-investigator assessment of risk of bias; consensus determination of strength of evidence. Data Synthesis: Eszopiclone, zolpidem, and suvorexant improved short-term global and sleep outcomes compared with placebo, although absolute effect sizes were small (low-to moderate-strength evidence). Evidence for benzodiazepine hypnotics, melatonin agonists, and antidepressants, and for most pharmacologic interventions in older adults, was insufficient or low strength. Evidence was also insufficient to compare efficacy within or across pharmacotherapy classes or versus behavioral therapy. Harms evidence reported in trials was judged insufficient or low strength; observational studies suggested that use of hypnotics for insomnia was associated with increased risk for dementia, fractures, and major injury. The FDA documents reported that most pharmacotherapies had risks for cognitive and behavioral changes, including driving impairment, and other adverse effects, and they advised dose reduction in women and in older adults. Limitations: Most trials were small and short term and enrolled individuals meeting stringent criteria. Minimum important differences in outcomes were often not established or reported. Data were scant for many treatments. Conclusion: Eszopiclone, zolpidem, and suvorexant may improve short-term global and sleep outcomes for adults with insomnia disorder, but the comparative effectiveness and longterm efficacy of pharmacotherapies for insomnia are not known. Pharmacotherapies for insomnia may cause cognitive and behavioral changes and may be associated with infrequent but serious harms.


Ejaz S.M.,Minnesota Regional Sleep Disorders Center | Ejaz S.M.,University of Minnesota | Khawaja I.S.,University of Minnesota | Khawaja I.S.,Veterans Affairs Medical Center | And 3 more authors.
Innovations in Clinical Neuroscience | Year: 2011

Obstructive sleep apnea is a common sleep disorder associated with several medical conditions, increased risk of motor vehicle accidents, and overall healthcare expenditure. There is higher prevalence of depression in people with obstructive sleep apnea in both clinical and community samples. Many symptoms of depression and obstructive sleep apnea overlap causing under-diagnosis of obstructive sleep apnea in depressed patients. Sleep problems, including obstructive sleep apnea, are rarely assessed on a regular basis in patients with depressive disorders, but they may be responsible for antidepressant treatment failure. The mechanism of the relationship between obstructive sleep apnea and depression is complex and remains unclear. Though some studies suggest a mutual relationship, the relationship remains unclear. Several possible pathophysiological mechanisms could explain how obstructive sleep apnea can cause or worsen depression. Increased knowledge of the relationship between obstructive sleep apnea and depression might significantly improve diagnostic accuracy as well as treatment outcomes for both obstructive sleep apnea and depression.


Antelmi E.,University of Bologna | Antelmi E.,University College London | Ferri R.,Ic Oasi Institute Irccs | Iranzo A.,Hospital Clinic Of Barcelona | And 8 more authors.
Sleep Medicine Reviews | Year: 2016

The states of being are conventionally defined by the simultaneous occurrence of behavioral, neurophysiological and autonomic descriptors. State dissociation disorders are due to the intrusion of features typical of a different state into an ongoing state. Disorders related to these conditions are classified according to the ongoing main state and comprise: 1) Dissociation from prevailing wakefulness as seen in hypnagogic or hypnopompic hallucinations, automatic behaviors, sleep drunkenness, cataplexy and sleep paralysis 2) Dissociation from rapid eye movement (REM) sleep as seen in REM sleep behavior disorder and lucid dreaming and 3) Dissociation from NREM sleep as seen in the disorders of arousal. The extreme expression of states dissociation is characterized by the asynchronous occurrence of the various components of the different states that prevents the recognition of any state of being. This condition has been named status dissociatus. According to the underlying disorders/diseases and to their severity, among status dissociatus we may recognize disorders in which such an extreme dissociation occurs only at night time or intermittently (i.e., autoimmune encephalopathies, narcolepsy type 1 and IgLON5 parasomnia), and others in which it occurs nearly continuously with complete loss of any conventionally defined state of being, and of the circadian pattern (agrypnia excitata).Here, we render a comprehensive review of all diseases/disorders associated with state dissociation and status dissociatus and propose a critical classification of this complex scenario. © 2015 Elsevier Ltd.


Van De Heyning P.H.,University of Antwerp | Badr M.S.,John ngell Va Medical Center | Baskin J.Z.,Cleveland VA Medical | Cramer Bornemann M.A.,Minnesota Regional Sleep Disorders Center | And 13 more authors.
Laryngoscope | Year: 2012

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 a;circ50 (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. Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.


Lee E.K.,Ottawa Health Research Institute | Kazaglis L.,Minnesota Regional Sleep Disorders Center
Psychiatric Annals | Year: 2015

Hypersomnolence disorders, encompassing both hypersomnolence and narcolepsy with or without hypocretin deficiency, have undergone a major update in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5). This update captures the paradigm shift that has advanced the understanding of these sleep disorders and their biological underpinnings. This article reviews the updated classification of hypersomnolence disorders in DSM-5. The prevalence, neuroanatomical basis, and clinical symptoms of these disorders are also explored. Hypersomnolence disorders can now be diagnosed comorbidly with other mental health disorders. This article explores this overlap and bidirectional relationship, along with the relationship between hypocretin deficiency and other mental health disorders. Finally, treatment strategies for hypersomnolence disorders and cataplexy are covered, including both behavioral and pharmacologic therapies.Traditional therapies and their proposed mechanisms of action are discussed, followed by a brief review of novel therapeutic agents undergoing clinical evaluation. Finally, recommendations for further exploration are reviewed. © SLACK Incorporated.


Bogan R.K.,SleepMed | Cramer Bornemann M.A.,Minnesota Regional Sleep Disorders Center | Kushida C.A.,Stanford University | Tran P.V.,Cortex Pharmaceuticals Inc. | Barrett R.W.,Xenoport
Mayo Clinic Proceedings | Year: 2010

OBJECTIVE: 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. © 2010 Mayo Foundation for Medical Education and Research.


Brasure M.,University of Minnesota | Fuchs E.,University of Texas Medical Branch | MacDonald R.,Minneapolis Veterans Affairs Health Care System | Nelson V.A.,University of Minnesota | And 9 more authors.
Annals of Internal Medicine | Year: 2016

Background: Psychological and behavioral interventions are frequently used for insomnia disorder. Purpose: To assess benefits and harms of psychological and behavioral interventions for insomnia disorder in adults. Data Sources: Ovid MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and PsycINFO through September 2015, supplemented with hand-searching. Study Selection: Randomized, controlled trials of psychological or behavioral interventions that were published in English and enrolled adults with insomnia disorder lasting 4 or more weeks. Data Extraction: Data extraction by single investigator confirmed by a second reviewer; dual investigator assessment of risk of bias; consensus determination of strength of evidence. Data Synthesis: Sixty trials with low to moderate risk of bias compared psychological and behavioral interventions with inactive controls or other psychological and behavioral interventions. Cognitive behavioral therapy for insomnia (CBT-I) improved posttreatment global and most sleep outcomes, often compared with information or waitlist controls (moderate-strength evidence). Use of CBT-I improved several sleep outcomes in older adults (low-to moderate-strength evidence). Multicomponent behavioral therapy improved several sleep outcomes in older adults (low-to moderate-strength evidence). Stimulus control improved 1 or 2 sleep outcomes (low-strength evidence). Evidence for other comparisons and for harms was insufficient to permit conclusions. Limitations: A wide variety of comparisons limited the ability to pool data. Trials did not always report global outcomes and infrequently conducted remitter or responder analysis. Comparisons were often information or waitlist groups, and publication bias was possible. Conclusion: Use of CBT-I improves most outcomes compared with inactive controls. Multicomponent behavioral therapy and stimulus control may improve some sleep outcomes. Evidence on other outcomes, comparisons, and long-term efficacy were limited.


Gross C.R.,University of Minnesota | Kreitzer M.J.,University of Minnesota | Reilly-Spong M.,University of Minnesota | Wall M.,University of Minnesota | And 4 more authors.
Explore: The Journal of Science and Healing | Year: 2011

Objective: The aim of this study was to investigate the potential of mindfulness-based stress reduction (MBSR) as a treatment for chronic primary insomnia. Design: A randomized controlled trial was conducted. Setting: The study was conducted at a university health center. Patients: Thirty adults with primary chronic insomnia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders, Text Revision, 4th Edition were randomized 2:1 to MBSR or pharmacotherapy (PCT). Interventions: Mindfulness-based stress reduction, a program of mindfulness meditation training consisting of eight weekly 2.5 hour classes and a daylong retreat, was provided, with ongoing home meditation practice expectations during three-month follow-up; PCT, consisting of three milligrams of eszopiclone (LUNESTA) nightly for eight weeks, followed by three months of use as needed. A 10-minute sleep hygiene presentation was included in both interventions. Main Outcomes: The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diaries, and wrist actigraphy were collected pretreatment, posttreatment (eight weeks), and at five months (self-reports only). Results: Between baseline and eight weeks, sleep onset latency (SOL) measured by actigraphy decreased 8.9 minutes in the MBSR arm (P < .05). Large, significant improvements were found on the ISI, PSQI, and diary-measured total sleep time, SOL, and sleep efficiency (P < .01, all) from baseline to five-month follow-up in the MBSR arm. Changes of comparable magnitude were found in the PCT arm. Twenty-seven of 30 patients completed their assigned treatment. This study provides initial evidence for the efficacy of MBSR as a viable treatment for chronic insomnia as measured by sleep diary, actigraphy, well-validated sleep scales, and measures of remission and clinical recovery. © 2011 Elsevier Inc.


Schenck C.H.,Minnesota Regional Sleep Disorders Center | Schenck C.H.,University of Minnesota | Howell M.J.,University of Minnesota
Sleep and Biological Rhythms | Year: 2013

Parasomnia Overlap Disorder (POD) was described and named in 1997 with a series of 33 cases of rapid eye movement (REM) sleep behavior disorder (RBD) combined with a disorder of arousal from non-rapid eye movement (NREM) sleep (sleepwalking, sleep terrors) that emerged idiopathically or symptomatically with neurological and other disorders. POD is a subtype of RBD in the International Classification of Sleep Disorders Diagnostic and Coding Manual, second edition (ICSD-2). An updated classification of POD also includes subclinical RBD-NREM parasomnia, RBD-sleep-related eating disorder, RBD-sexsomnia, RBD-rhythmic movement disorder, and status dissociatus (SD), which is another subtype of RBD in the ICSD-2. Similar to POD, a core feature of SD is sleep motor-behavioral dyscontrol, with release of dream-related behaviors suggestive of RBD, but with nearly continuous ambiguous polygraphic sleep precluding the identification of NREM/REM sleep states. SD exemplifies extreme state dissociation. SD is always a symptomatic disorder, and is causally associated with a broad range of neurologic disorders, often with thalamic, limbic, striatal, and pontine involvement. The parasomnia behaviors associated with POD and SD - typical RBD behaviors - can often be controlled with bedtime clonazepam therapy, including the abnormal dreaming. © 2013 The Authors Sleep and Biological Rhythms © 2013 Japanese Society of Sleep Research.


Schenck C.H.,Minnesota Regional Sleep Disorders Center
NeuroQuantology | Year: 2015

The first classification of sleep-related disorders and abnormal sexual behaviors and experiences was published in 2007. Parasomnias (abnormal sleep-related behaviors and experiences) and sleep-related epileptic seizures were the most frequent disorders, after Kleine-Levin syndrome (periodic hypersomnia with abnormal wakeful sexual behaviors). The first two conditions were named sexsomnia (sleepsex) and epileptic (ictal) exsomnia, respectively. Sexsomnia usually emerges during confusional arousals (CAs) from delta non-REM sleep (N3 sleep), either associated or unassociated with obstructive sleep apnea (OSA). We now report an additional 22 cases of sexsomnia and 3 cases of ictal sexsomnia (temporal lobe epilepsy; bupropion-induced seizures) published from 2007-2015, based on a literature search in PubMed and Embase, and also separately for Turkish language publications. Eighteen of the 22 additional cases of sexsomnia had sufficient data provided to allow for comparative analysis. (The 4 other additional cases involved sexsomnia emerging with Parkinson's disease). The demographics of the second group of 18 sexsomnia cases were comparable to those of the first group of 31 cases (published in 2007), in regards to male gender predominance (67% vs. 81%); age at presentation (40 yrs vs. 32 yrs); age of onset (33 yrs vs. 26 yrs); and mean duration of sexsomnia in males (5.6 yrs vs. 8.3 yrs). The female groups were too small to compare. The distribution of sexual behaviors across the groups was generally comparable in regards to sexual vocalizations, masturbation, fondling, and intercourse/attempted intercourse. Amnesia for the sexsomnia by the affected person was 89% vs. 100%. Video-polysomnographic studies wereconducted in nearly all patients in both groups, and provided important diagnostic findings in almost all patients. The mean number of arasomnias per patient was 1.8+1.4 vs. 2.2+1.0, respectively, with the range extending up to 5 parasomnias per patient. In both groups, a non-REM sleep parasomnia (disorder of arousal [DOA]) was the main cause of the sexsomnia (78% vs. 90%). There was a comparable percentage in each group having obstructive sleep apnea (OSA) as the presumed trigger for a DOA with sexsomnia (17% vs. 13%), and there was control of both sexsomnia and OSA with nasal CPAP in 100% (4/4) of treated cases. Overall treatment efficacy was 82% (n=18) in the 22 patients in the combined groups (n=53) for whom treatment was reported. Nine novel findings on sexsomnia were identified. An abstract on 41 consecutive cases of sexsomnia evaluated at a single sleep center in the U.K. was recently published, and the findings are highly congruent with the 53 cumulative cases in the world literature reported herein. Thus, there are now 94 total cases of sexsomnia reported in the world literature. The forensic implications of sexsomnia are discussed. © 2015 NeuroQuantology. All rights reserved.

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