Facilitators of and barriers to hip protector acceptance and adherence in long-term care facilities: a systematic review.

BACKGROUND: Hip protectors represent an attractive strategy for reducing hip fractures among high-risk fallers in long-term care facilities. However, clinical studies yield conflicting results regarding their clinical value. This is mainly due to poor acceptance and adherence among users in wearing these devices. As a result, there is an urgent need to identify potential barriers and facilitators to initial acceptance and continued adherence with hip protector use. PURPOSE: The objective of this systematic review is to synthesize available research evidence to identify factors that influence acceptance and adherence among older adults living in long-term care facilities. METHODS: A key word search was conducted for studies published in English between 2000 and 2013 that employed quantitative, qualitative, or mixed-methods research designs. Two independent reviewers evaluated each article for inclusion, with a third reviewer when needed to resolve discrepancies. RESULTS: Twenty-eight articles met our inclusion criteria, and facilitators and barriers were clustered into 4 socio-ecological levels: system (eg, facility commitment, staff shortages), caregiver (eg, belief in the efficacy of protectors, negative perceptions), resident (eg, clinical risk factors for falls and related fractures, acute illness), and product (eg, soft shell, discomfort). DISCUSSION: The outcomes provide decision makers, health professionals, and caregivers with a greater awareness of strategies to improve compliance with the use of hip protectors. Furthermore, researchers can use this information to design clinical trials that yield high acceptance and adherence.

Stroke rehabilitation and patients with multimorbidity: a scoping review protocol.

Stroke care presents unique challenges for clinicians, as most strokes occur in the context of other medical diagnoses. An assessment of capacity for implementing "best practice" stroke care found clinicians reporting a strong need for training specific to patient/system complexity and multimorbidity. With mounting patient complexity, there is pressure to implement new models of healthcare delivery for both quality and financial sustainability. Policy makers and administrators are turning to clinical practice guidelines to support decision-making and resource allocation. Stroke rehabilitation programs across Canada are being transformed to better align with the Canadian Stroke Strategy's Stroke Best Practice Recommendations. The recommendations provide a framework to facilitate the adoption of evidence-based best practices in stroke across the continuum of care. However, given the increasing and emerging complexity of patients with stroke in terms of multimorbidity, the evidence supporting clinical practice guidelines may not align with the current patient population. To evaluate this, electronic databases and gray literature will be searched, including published or unpublished studies of quantitative, qualitative or mixed-methods research designs. Team members will screen the literature and abstract the data. Results will present a numerical account of the amount, type, and distribution of the studies included and a thematic analysis and concept map of the results. This review represents the first attempt to map the available literature on stroke rehabilitation and multimorbidity, and identify gaps in the existing research. The results will be relevant for knowledge users concerned with stroke rehabilitation by expanding the understanding of the current evidence.

Continuous versus intermittent infusions of antibiotics for the treatment of severe acute infections.

BACKGROUND: Intravenous broad-spectrum antibiotics are indicated for the treatment of severe infections. However, the emergence of infections caused by multi-drug resistant organisms in conjunction with a lack of novel antibiotics has prompted the investigation of alternative dosing strategies to improve clinical efficacy and tolerability. To optimise pharmacokinetic and pharmacodynamic antibiotic parameters, continuous antibiotic infusions have been compared to traditional intermittent antibiotic infusions. OBJECTIVES: To compare the clinical efficacy and safety of continuous intravenous administration of concentration-dependent and time-dependent antibiotics to traditional intermittent intravenous administration in adults with severe acute bacterial infections. SEARCH METHODS: The following electronic databases were searched in September 2012: The Cochrane Injuries Group Specialised Register, Cochrane Central Register of Controlled Trials (The Cochrane Library), MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL, ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED), ISI Web of Science: Conference Proceedings Citation Index-Science (CPCI-S). The reference lists of all relevant material, the Internet and the trials registry www.clinicaltrials.gov for completed and ongoing trials were also searched. SELECTION CRITERIA: Randomized controlled trials in adults with a bacterial infection requiring intravenous antibiotic therapy comparing continuous versus intermittent infusions of antibiotics were included. Both time-dependent and concentration-dependent antibiotics were considered. DATA COLLECTION AND ANALYSIS: Three independent authors performed data extraction for the included studies. All data was cross-checked and disagreements resolved by consensus. An intention to treat analysis was conducted using a random-effects model. MAIN RESULTS: Twenty-nine studies met inclusion criteria with a combined total of over 1,600 patients. The majority of included studies were judged to be at unclear or high risk of bias with regard to randomisation sequence generation, allocation concealment, blinding, management of incomplete outcome data, selective outcome reporting, and other potential threats to validity. No studies were judged to be at low risk of bias for all methodological quality items assessed. There were no differences in all-cause mortality (n=1241, RR 0.89, 95% CI 0.67 - 1.20, p=0.45), infection recurrence (n=398, RR 1.22, 95% CI 0.35 - 4.19, p=0.76), clinical cure (n=975, RR 1.00, 95% CI 0.93 - 1.08, p=0.98), and superinfection post-therapy (n=813, RR 1.08, 95% CI 0.60 - 1.94, p=0.79). There were no differences in safety outcomes including adverse events (n=575, RR 1.02, 95% CI 0.94 - 1.12, p=0.63), serious adverse events (n=871, RR 1.36, 95% CI 0.80 - 2.30, p=0.26), and withdrawal due to adverse events (n=871, RR 2.03, 95% CI 0.52 - 7.95, p=0.31). A difference was observed in the subgroup analyses of clinical cure in septic versus non-septic patients, where intermittent antibiotic infusions were favoured for clinical cure in septic patients. However, this effect was not consistent between random-effects and fixed-effects analyses. No differences were found in sensitivity analyses conducted. AUTHORS' CONCLUSIONS: There were no differences in mortality, infection recurrence, clinical cure, superinfection post-therapy, and safety outcomes when comparing continuous infusions of intravenous antibiotics to traditional intermittent infusions of antibiotics. However, the wide confidence intervals suggest that beneficial or harmful effects cannot be ruled out for all outcomes. Therefore, the current evidence is insufficient to recommend the widespread adoption of continuous infusion antibiotics in the place of intermittent infusions of antibiotics. Further large prospective randomised trials, with consistent and complete reporting of clinical outcome measures, conducted with concurrent pharmacokinetic and pharmacodynamic studies in special populations are required to determine whether adoption of continuous antibiotic infusions is warranted in specific circumstances.

Focussing both eyes on health outcomes: revisiting cataract surgery.

BACKGROUND: The appropriateness of cataract surgery procedures has been questioned, the suggestion being that the surgery is sometimes undertaken too early in the disease progression. Our three study questions were: What is the level of visual impairment in patients scheduled for cataract surgery? What is the improvement following surgery? Given the thresholds for a minimal detectable change (MDC) and a minimal clinically important difference (MCID), do gains in visual function reach the MDC and MCID thresholds? METHODS: The sample included a prospective cohort of cataract surgery patients from four Fraser Health Authority ophthalmologists. Visual function (VF-14) was assessed pre-operatively and at seven weeks post-operatively. Two groups from this cohort were included in this analysis: 'all first eyes' (cataract extraction on first eye) and 'both eyes' (cataract removed from both eyes). Descriptive statistics, change scores for VF-14 for each eye group and proportion of patients who reach the MDC and MCID are reported. RESULTS: One hundred and forty-two patients are included in the 'all first eyes' analyses and 55 in the 'both eyes' analyses. The mean pre-operative VF-14 score for the 'all first eyes' group was 86.7 (on a 0-100 scale where 100 is full visual function). The mean change in VF-14 for the 'both eyes' group was 7.5. Twenty-three percent of patients achieved improvements in visual function beyond the MCID threshold and 35% saw improvement beyond the MDC. CONCLUSIONS: Neither threshold level for MDC or MCID for the VF-14 scale was achieved for a majority of patients. A plausible explanation for this is the very high levels of pre-operative visual functioning.

Carnitine for fatigue in multiple sclerosis.

BACKGROUND: Fatigue is reported to occur in up to 92% of patients with multiple sclerosis (MS) and has been described as the most debilitating of all MS symptoms by 28% to 40% of MS patients. OBJECTIVES: To assess whether carnitine (enteral or intravenous) supplementation can improve the quality of life and reduce the symptoms of fatigue in patients with MS-related fatigue and to identify any adverse effects of carnitine when used for this purpose. SEARCH METHODS: A literature search was performed using Cochrane MS Group Trials Register (09 September 2011), Cochrane Central Register of Controlled Trials (CENTRAL) "The Cochrane Library 2011, issue 3", MEDLINE (PubMed) (1966-09 September 2011), EMBASE (1974-09 September 2011), and www.clinicaltrials.gov for ongoing trials retrieval. Reference lists of review articles and primary studies were also screened. A hand search of the abstract book of recent relevant conference symposia was also conducted. Personal contact with MS experts and a manufacturer (Source Naturals, United States) of carnitine formulation was contacted to determine if they knew of other clinical trials. No language restrictions were applied. SELECTION CRITERIA: Full reports of published and unpublished randomized controlled trials and quasi-randomized trials of any carnitine intervention in adults affected by multiple sclerosis with a clinical diagnosis of fatigue associated with multiple sclerosis were included. DATA COLLECTION AND ANALYSIS: Data from the eligible trials was extracted and coded using a standardized data extraction form and entered into RevMan 5. Discrepancies were to be resolved by discussion with a third reviewer, however this was not necessary.The quality items to be assessed were method of randomization, allocation concealment, blinding (participants, investigators, outcome assessors and data analysis), intention-to-treat analysis and completeness of follow up. MAIN RESULTS: The search identified one ongoing randomized, placebo-controlled, cross-over trial (expected completion 2013) and one completed randomized, active-comparator, cross-over trial. In the completed study, adult patients with relapsing-remitting and secondary progressive MS were exposed to both acetyl L-carnitine 2 grams daily and amantadine 200 mg daily The effects of carnitine on fatigue are unclear. There was no difference between carnitine and amantadine for the number of patients withdrawing from the study due to an adverse event (relative risk ratio 0.20; 95% confidence interval 0.03 to 1.55) and no patients experienced a serious adverse event in either treatment group. Mortality and quality of life were not reported. AUTHORS' CONCLUSIONS: There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators. Results of the ongoing trial are eagerly anticipated in order to provide clarity.

A randomized controlled trial of CBT therapy for adults with ADHD with and without medication.

BACKGROUND: Previous studies of psychological treatment in adults with ADHD have not controlled for medication status and include either medicated participants or mixed samples of medicated and unmedicated participants. The objective of this study is to examine whether use of medication improves outcome of therapy. METHOD: This was a secondary analysis comparing 23 participants randomized to CBT and Dextroamphetamine vs. 25 participants randomized to CBT and placebo. Both patients and investigators were blind to treatment assignment. Two co-primary outcomes were used: ADHD symptoms on the ADHD-RS-Inv completed by the investigator and improvement in functioning as reported by the patient on the Sheehan Disability Scale. RESULTS: Both groups showed robust improvement in both symptoms and functioning, but the use of medication did not significantly improve outcome over and above use of CBT and placebo. CONCLUSION: This study replicates previous work demonstrating that CBT is an effective treatment for ADHD in adults. Within the limits of this pilot, secondary analysis we were not able to demonstrate that medication significantly augments the outcome of CBT therapy for adults with ADHD. The study was funded by GlaxoSmithKline, Clinical Trials Registry #GSK707.

The benefits of laparoscopic appendectomies in obese patients.

BACKGROUND: Systematic reviews and randomized controlled trials comparing laparoscopic appendectomy (LA) with open appendectomy (OA) show a reduction in wound infections associated with LA but a 3-fold increase in intra-abdominal abscess with LA. Surgical time and operation costs are higher with LA. The advantage of LA over OA is small. Although these patients have not been specifically analyzed in the report, the systematic review recommends the routine use of LA in young women and obese people. The purpose of this study is to determine if obese patients benefit in a shorter length of stay (LOS) by having LA versus OA surgery compared with their nonobese counterparts. METHODS: A retrospective chart review of 315 adult patients who have undergone appendectomies at Royal Columbian and Burnaby Hospitals between April 1, 2010 and March 31, 2011. Appendectomies performed in pregnant women combined with other surgeries and those converted to OA were excluded. Outcomes and the postoperative stay for obese and nonobese patients were assessed. RESULTS: The LOS is shorter with LAs than with OAs (2.06 vs 4.13 days, P < .05). The LOS, in obese patients, is much shorter with LAs than with OAs (1.69 vs 6.82 days, P < .05). The variability in LOS is much higher in obese patients as compared with nonobese patients (standard deviation = 8.57 vs 2.67). The body mass index and the type of surgery contribute to a significant difference in LOS. CONCLUSIONS: Obese patients who undergo LA have a decreased LOS as compared with obese patients who undergo OA for appendicitis. This is the first study showing specifically that LA benefits obese patients and the health care system.

Neurophysiology of circadian rhythm sleep disorders of children with neurodevelopmental disabilities.

This article reviews circadian rhythm sleep disorders (CRSDs) of children with neurodevelopmental disabilities. These sleep disturbances frequently occur in this population but they are misunderstood and under diagnosed. The causes and features of CRSD in children with brain disorders differ in many ways from those seen in typically developing children. It is the brain, including the eyes, which regulates sleep and circadian rhythmicity by modulating pineal melatonin production/secretion and when there is significant brain damage, the sleep/wake patterns may be modified. In most instances CRSD are not disorders of the suprachiasmatic nuclei because these small hypothalamic structures only adjust their functions to the changing photic and non-photic modulatory influences. Each form of CRSD is accompanied by characteristic changes in serum melatonin levels and clinical features. When nocturnal melatonin production/secretion is inappropriately timed or impaired in relation to the environment, timed melatonin replacement therapy will often be beneficial. In this review an attempt is made to clarify the neurophysiological mechanisms underlying the various forms of CRSD because without understanding the photic and non-photic influences on sleep, these sleep disorders can not be fully characterized, defined or even appropriately treated. In the future, the existing definitions for the different forms of CRSD should be modified by experts in pediatric sleep medicine in order to include children with neurodevelopmental disabilities.

Categorical and Dimensional Definitions and Evaluations of Symptoms of ADHD: History of the SNAP and the SWAN Rating Scales.

An earlier version of this article was originally submitted for publication in early 2000 to introduce a new dimensional of concept of Attention Deficit Hyperactivity Disorder (ADHD) provided by the Strengths and Weaknesses of ADHD-symptoms and Normal-behavior (SWAN) rating scale. The SWAN was developed to correct some obvious deficiencies of the Swanson, Nolan and Pelham (SNAP) rating scale that was based on the categorical concept of ADHD. The first submission was not accepted for publication, so a draft of the article was posted on a website (www.ADHD.net). The SWAN scale was published as a table in a review article (Swanson et al, 2001) to make it available to those interested in this dimensional approach to assessment of ADHD. Despite its relative inaccessibility, the SWAN has been used in several genetic studies of ADHD (e.g., Hay, Bennett, Levy, Sergeant, & Swanson, 2005; Cornish et al, 2005) and has been translated into several languages for European studies of ADHD (e.g., Lubke et al, 2006; Polderman et al, 2010) and into Spanish for studies in the United States (e.g., Lakes, Swanson, & Riggs, 2011; Kudo et al., this issue). Recently, invitations to include the SWAN in the PhenX Toolkit (www.phenx.org) for genomic studies (Hamilton et al, 2011) and to describe thedimensional approach of the SWAN for discussion of diagnostic (Swanson, Wigal, & Lakes, 2009) and ethical (Swanson, Wigal, Lakes, &Volkow, 2011) issues has convinced us that the unpublished article is still relevant after more than a decade, so it is presented here with some minor updates. We use examples (a) to document some consequences (e.g., over-identification of extreme cases) of using statistical cutoffs based on the assumption for a distribution of SNAP ratings that is highly skewed and (b) to show how the SWAN corrects the skewness of the SNAP by rewording the items on the scale and using a wider range of rating alternatives, which corrects the tendency to over-identify extreme cases.

Clinical correlates of oppositional defiant disorder and attention-deficit/hyperactivity disorder in adults.

OBJECTIVE: Oppositional defiant disorder (ODD) is a common comorbidity of attention-deficit/hyperactivity disorder (ADHD) in both children and adolescents. Although there is research demonstrating that ADHD persists into adulthood, less is known about the frequency of its persistence, clinical characteristics, and impairment when associated with comorbid ODD in adults with ADHD. METHOD: Data from a randomized clinical trial of adults with ADHD were analyzed to determine the prevalence and clinical correlates of comorbid ODD. As per the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria, patients who reported having ≥ 4 symptoms "often" or "very often" were classified as meeting the symptom criteria for the disorder. RESULTS: Forty percent of this sample met symptom criteria for ODD. Subjects with ODD were more likely to have other comorbid disorders, lower investigator ratings of overall functioning, and lower patient life satisfaction (P < 0.05). A regression analysis using these variables predicted 40% of the variance of ODD as a comorbid condition in addition to ADHD. Although the presence or absence of ODD at baseline does not moderate response of ADHD symptoms with treatment, improvement in ODD symptoms was mediated by improvement in ADHD symptoms (P < 0.0001). Oppositional defiant disorder treatment was more responsive to dextroamphetamine than paroxetine, despite the contribution of irritability and reactive tantrums, as symptoms of the disorder. CONCLUSION: Oppositional defiant disorder is a valid and impairing disorder requiring evaluation and treatment in adults.

Cerebral modulation of circadian sleep-wake rhythms.

The objective of this prospective observational study was to assess the association between dysrhythmia of EEG background (disturbance of cerebral connectivity) and sleep difficulties. Sixty children, aged 4 to 12 years, participated. Hospital records were reviewed, and sleep histories were obtained by interviewing the parents. EEGs of 39 subjects were normal, showed epileptiform activity, and/or mild to moderate background dysrhythmia. Severe unilateral dysrhythmia was noted in 6 and bilaterally in 15 EEGs, with all 15 children having profound neurodevelopmental disabilities and 14 of these 15 having long-standing severe chaotic sleep/wake patterns. Thus, there was a highly significant association between EEG evidence of severe bilateral dysrhythmia and chronic sleep/wake dysregulation. Unilateral dysrhythmia was not associated with sleep difficulties. This study delineates a specific sleep disorder in a group of children with marked neurodevelopmental disabilities and offers insight into how disturbed cerebral connectivity impacts the thalamocortical dynamics relating to neurodevelopmental disabilities, sleep, and melatonin production.

Melatonin has membrane receptor-independent hypnotic action on neurons: an hypothesis.

Melatonin, which is known to have sleep-promoting properties, has no morpho-physiological barriers and readily enters neurons and their subcellular compartments from both the blood and cerebrospinal fluid. It has multiple receptor-dependent and receptor-independent functions. Sleep is a neuronal function, and it can no longer be postulated that one or more anatomical structures fully control sleep. Neurons require sleep for metabolically driven restorative purposes, and as a result, the process of sleep is modulated by peripheral and central mechanisms. This is an important finding because it suggests that melatonin should have intracellular sleep-inducing properties. Based on recent evidence, it is proposed that melatonin induces sleep at the neuronal level independently of its membrane receptors. Thus, the hypnotic action of melatonin and the mechanisms involving the circadian rhythms are separate neurological functions. This is contrary to the presently accepted view.

Sleep Health Issues for Children with FASD: Clinical Considerations.

This article describes the combined clinical experience of a multidisciplinary group of professionals on the sleep disturbances of children with fetal alcohol spectrum disorders (FASD) focusing on sleep hygiene interventions. Such practical and comprehensive information is not available in the literature. Severe, persistent sleep difficulties are frequently associated with this condition but few health professionals are familiar with both FASD and sleep disorders. The sleep promotion techniques used for typical children are less suitable for children with FASD who need individually designed interventions. The types, causes, and adverse effects of sleep disorders, the modification of environment, scheduling and preparation for sleep, and sleep health for their caregivers are discussed. It is our hope that parents and also researchers, who are interested in the sleep disorders of children with FASD, will benefit from this presentation and that this discussion will stimulate much needed evidence-based research.

Nutritional status of children with attention deficit hyperactivity disorder: a pilot study.

Objectives. This is a pilot study of the dietary intake and nutrient status of children with Attention Deficit Hyperactivity Disorder (ADHD). Method. Nutritional assessment of 43 children aged 6-12 with ADHD was performed using a 3-day food record, 24-hour recall, and serum assessors. Results. Macronutrient intake and consumption of Low-Nutrient Foods were comparable to population norms; however, 66% were found to be deficient in zinc and 23% in copper. Conclusions. This pilot study reports the food intake and nutrient status of children with ADHD and shows a predisposition for low zinc and copper status in ADHD.

Long-term sleep disturbances in children: a cause of neuronal loss.

Short-term sleep loss is known to cause temporary difficulties in cognition, behaviour and health but the effects of persistent sleep deprivation on brain development have received little or no attention. Yet, severe sleep disorders that last for years are common in children especially when they have neurodevelopmental disabilities. There is increasing evidence that chronic sleep loss can lead to neuronal and cognitive loss in children although this is generally unrecognized by the medical profession and the public. Without the restorative functions of sleep due to total sleep deprivation, death is inevitable within a few weeks. Chronic sleep disturbances at any age deprive children of healthy environmental exposure which is a prerequisite for cognitive growth more so during critical developmental periods. Sleep loss adversely effects pineal melatonin production which causes disturbance of circadian physiology of cells, organs, neurochemicals, neuroprotective and other metabolic functions. Through various mechanisms sleep loss causes widespread deterioration of neuronal functions, memory and learning, gene expression, neurogenesis and numerous other changes which cause decline in cognition, behaviour and health. When these changes are long-standing, excessive cellular stress develops which may result in widespread neuronal loss. In this review, for the first time, recent research advances obtained from various fields of sleep medicine are integrated in order to show that untreated chronic sleep disorders may lead to impaired brain development, neuronal damage and permanent loss of developmental potentials. Further research is urgently needed because these findings have major implications for the treatment of sleep disorders.

Carnitine for fatigue in multiple sclerosis.

BACKGROUND: Fatigue is reported to occur in up to 92% of patients with multiple sclerosis (MS) and has been described as the most debilitating of all MS symptoms by 28% to 40% of MS patients. OBJECTIVES: To assess whether carnitine (enteral or intravenous) supplementation can improve the quality of life and reduce the symptoms of fatigue in patients with MS-related fatigue and to identify any adverse effects of carnitine when used for this purpose. SEARCH STRATEGY: A literature search was performed using Cochrane MS Group Trials Register (21 May 2009), Cochrane Central Register of Controlled Trials (CENTRAL) "The Cochrane Library 2009, issue 2, MEDLINE (PubMed) (1966-21 May 2009), EMBASE (1974-21 May 2009). Reference lists of review articles and primary studies were also screened. A hand search of the abstract book of recent relevant conference symposia was also conducted. Personal contact with MS experts and a manufacturer (Source Naturals, United States) of carnitine formulation was contacted to determine if they knew of other clinical trials. No language restrictions were applied. SELECTION CRITERIA: Full reports of published and unpublished randomized controlled trials and quasi-randomized trials of any carnitine intervention in adults with a clinical diagnosis of fatigue associated with multiple sclerosis were included. DATA COLLECTION AND ANALYSIS: Data from the eligible trials was extracted and coded using a standardized data extraction form and entered into RevMan 5. Discrepancies were to be resolved by discussion with a third reviewer however this was not necessary. The quality items to be assessed were method of randomization, allocation concealment, blinding (participants, investigators, outcome assessors and data analysis), intention-to-treat analysis and completeness of follow up. MAIN RESULTS: The search identified one randomized cross-over trial. In this study patients were exposed to both acetyl L-carnitine (ALCAR(tm)) 2 grams daily and amantadine 200 mg daily in adult patients with relapsing-remitting and secondary progressive MS. The effects of carnitine on fatigue are not clear based on the one included crossover RCT. There was no difference between carnitine and amantadine for the number of patients withdrawing from the study due to an adverse event (relative risk ratio 0.20; 95% confidence interval 0.03 to 1.55. Mortality, serious adverse events, total adverse events, and quality of life were not reported. AUTHORS' CONCLUSIONS: There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators.

The role of the thalamus in sleep, pineal melatonin production, and circadian rhythm sleep disorders.

The thalamus has a strong nonphotic influence on sleep, circadian rhythmicity, pineal melatonin production, and secretion. The opening of the sleep gate for nonrapid eye movement sleep is a thalamic function but it is assisted by melatonin which acts by promoting spindle formation. Thus, melatonin has a modulatory influence on sleep onset and maintenance. A remarkable similarity exists between spindle behavior, circadian rhythmicity, and pineal melatonin production throughout life. Together, the thalamic and chronobiological control of sleep leads to a new and improved understanding of the pathophysiology of circadian rhythm sleep disorders and also of the principles of sleep hygiene interventions.

Sleep hygiene for children with neurodevelopmental disabilities.

Sleep disturbances in children with neurodevelopmental disabilities are common and have a profound effect on the quality of life of the child, as well as the entire family. Although interventions for sleep problems in these children often involve a combination of behavioral and pharmacologic strategies, the first line of treatment is the promotion of improved sleep habits or "hygiene." Despite the importance of sleep-hygiene principles, defined as basic optimal environmental, scheduling, sleep-practice, and physiologic sleep-promoting factors, clinicians often lack appropriate knowledge and skills to implement them. In addition, sleep-hygiene practices may need to be modified and adapted for this population of children and are often more challenging to implement compared with their healthy counterparts. This first comprehensive, multidisciplinary review of sleep hygiene for children with disabilities presents the rationale for incorporating these measures in their treatment, outlines both general and specific sleep-promotion practices, and discusses problem-solving strategies for implementing them in a variety of clinical practice settings.

A randomized, placebo-controlled trial of controlled release melatonin treatment of delayed sleep phase syndrome and impaired sleep maintenance in children with neurodevelopmental disabilities.

The purpose of this study was to determine the efficacy of controlled-release (CR) melatonin in the treatment of delayed sleep phase syndrome and impaired sleep maintenance of children with neurodevelopmental disabilities including autistic spectrum disorders. A randomized double-blind, placebo-controlled crossover trial of CR melatonin (5 mg) followed by a 3-month open-label study was conducted during which the dose was gradually increased until the therapy showed optimal beneficial effects. Sleep characteristics were measured by caregiver who completed somnologs and wrist actigraphs. Clinician rating of severity of the sleep disorder and improvement from baseline, along with caregiver ratings of global functioning and family stress were also obtained. Fifty-one children (age range 2-18 years) who did not respond to sleep hygiene intervention were enrolled. Fifty patients completed the crossover trial and 47 completed the open-label phase. Recordings of total night-time sleep and sleep latency showed significant improvement of approximately 30 min. Similarly, significant improvement was observed in clinician and parent ratings. There was additional improvement in the open-label somnolog measures of sleep efficiency and the longest sleep episode in the open-label phase. Overall, the therapy improved the sleep of 47 children and was effective in reducing family stress. Children with neurodevelopmental disabilities, who had treatment resistant chronic delayed sleep phase syndrome and impaired sleep maintenance, showed improvement in melatonin therapy.