Melatonin in Youth: N-of-1 trials in a stimulant-treated ADHD Population (MYNAP): study protocol for a randomized controlled trial

Attention-deficit/hyperactivity disorder (ADHD) is a common neurological disorder affecting 5\ua0% of children worldwide. A prevalent problem for children with ADHD is initial insomnia. The gold standard treatment to manage ADHD symptoms is stimulant medications, which may exacerbate the severity of existing initial insomnia. Currently, no gold standard treatment option exists for initial insomnia for these children. Melatonin, a hormone and a popular natural health product, is commonly provided to children by parents and recommended by healthcare providers, but high quality pediatric evidence is lacking.This trial is a multicenter randomized triple-blind, placebo-controlled, parallel-group, randomized, controlled trial (RCT), in which each participant is offered an N-of-1 trial. An N-of-1 trial is a multiple-crossover, randomized, controlled trial conducted in a single individual. For the N-of-1 trial, each participant will undergo three pairs of treatment/placebo periods; each period is 1\ua0week in length. Half the participants will have melatonin in the first period, the other half will start with placebo, and this will make up the parallel-group RCT. The primary outcome will be mean difference in sleep onset latency as measured by sleep diaries. A comparison of treatment effects yielded by the RCT data versus the aggregated N-of-1 trial data will also be assessed.This trial will provide rigorous evidence for the effectiveness of melatonin in children with ADHD on stimulants who experience initial insomnia. Further, this study will provide the first prospectively planned head-to-head comparison of RCT data with pooled data from a series of N-of-1 trials. Aggregated N-of-1 trials may be a powerful tool to produce high quality clinical trial evidence.ClinicalTrials.gov, NCT02333149 . Registered on 16 December 2014. Australian New Zealand Clinical Trials Registry, ACTRN12614000542695 . Registered on 21 May 2014

Evaluation of an internet-based behavioral intervention to improve psychosocial health outcomes in children with insomnia (Better Nights, Better Days): Protocol for a randomized controlled trial

Background: Up to 25% of 1- to 10-year-old children experience insomnia (ie, resisting bedtime, trouble falling asleep, night awakenings, and waking too early in the morning). Insomnia can be associated with excessive daytime sleepiness and negative effects on daytime functioning across multiple domains (eg, behavior, mood, attention, and learning). Despite robust evidence supporting the effectiveness of behavioral treatments for insomnia in children, very few children with insomnia receive these treatments, primarily due to a shortage of available treatment resources. Objective: The Better Nights, Better Days (BNBD) internet-based program provides a readily accessible electronic health (eHealth) intervention to support parents in providing evidence-based care for insomnia in typically developing children. The purpose of the randomized controlled trial (RCT) is to evaluate the effectiveness of BNBD in treating insomnia in children aged between 1 and 10 years. Methods: BNBD is a fully automated program, developed based on evidence-based interventions previously tested by the investigators, as well as on the extant literature on this topic. We describe the 2-arm RCT in which participants (500 primary caregivers of children with insomnia residing in Canada) are assigned to intervention or usual care. Results: The effects of this behavioral sleep eHealth intervention will be assessed at 4 and 8 months postrandomization. Assessment includes both sleep (actigraphy, sleep diary) and daytime functioning of the children and daytime functioning of their parents. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials statement. Conclusions: If the intervention is supported by the results of the RCT, we plan to commercialize this program so that it is sustainable and available at a low cost to all families with internet access

Pediatric home mechanical ventilation: A Canadian Thoracic Society clinical practice guideline executive summary

Over the last 30 to 40 years, improvements in technology, as well as changing clinical practice regarding the appropriateness of long-term ventilation in patients with “non-curable” disorders, have resulted in increasing numbers of children surviving what were previously considered fatal conditions. This has come but at the expense of requiring ongoing, long-term prolonged mechanical ventilation (both invasive and noninvasive). Although there are many publications pertaining to specific aspects of home mechanical ventilation (HMV) in children, there are few comprehensive guidelines that bring together all of the current literature. In 2011 the Canadian Thoracic Society HMV Guideline Committee published a review of the available English literature on topics related to HMV in adults, and completed a detailed guideline that will help standardize and improve the assessment and management of individuals requiring noninvasive or invasive HMV. This current document is intended to be a companion to the 2011 guidelines, concentrating on the issues that are either unique to children on HMV (individuals under 18 years of age), or where common pediatric practice diverges significantly from that employed in adults on long-term home ventilation. As with the adult guidelines,1 this document provides a disease-specific review of illnesses associated with the necessity for long-term ventilation in children, including children with chronic lung disease, spinal muscle atrophy, muscular dystrophies, kyphoscoliosis, obesity hypoventilation syndrome, and central hypoventilation syndromes. It also covers important common themes such as airway clearance, the ethics of initiation of long-term ventilation in individuals unable to give consent, the process of transition to home and to adult centers, and the impact, both financial, as well as social, that this may have on the child\u27s families and caregivers. The guidelines have been extensively reviewed by international experts, allied health professionals and target audiences. They will be updated on a regular basis to incorporate any new information

Children\u27s Sleep during COVID-19: How Sleep Influences Surviving and Thriving in Families

Objective The COVID-19 pandemic has the potential to disrupt the lives of families and may have implications for children with existing sleep problems. As such, we aimed to: (1) characterize sleep changes during the COVID-19 pandemic in children who had previously been identified as having sleep problems, (2) identify factors contributing to sleep changes due to COVID-19 safety measures, and (3) understand parents and children s needs to support sleep during the pandemic. Methods Eighty-five Canadian parents with children aged 4 14 years participated in this explanatory sequential, mixed-methods study using an online survey of children s and parents sleep, with a subset of 16 parents, selected based on changes in their children s sleep, participating in semi-structured interviews. Families had previously participated in the Better Nights, Better Days (BNBD) randomized controlled trial. Results While some parents perceived their child s sleep quality improved during the COVID-19 pandemic (14.1%, n 12), many parents perceived their child s sleep had worsened (40.0%, n 34). Parents attributed children s worsened sleep to increased screen time, anxiety, and decreased exercise. Findings from semi-structured interviews highlighted the effect of disrupted routines on sleep and stress, and that stress reciprocally influenced children s and parents sleep. Conclusions The sleep of many Canadian children was affected by the first wave of the COVID-19 pandemic, with the disruption of routines influencing children s sleep. eHealth interventions, such as BNBD with modifications that address the COVID-19 context, could help families address these challenges

Development and Growth of a Large Multispecialty Certification Examination: Sleep Medicine Certification—Results of the First Three Examinations

This paper summarizes the results of the first three examinations (2007, 2009, and 2011) of the Sleep Medicine Certification Examination, administered by its six sponsoring American Board of Medical Specialty Boards. There were 2,913 candidates who took the 2011 examination through one of three pathways—self-attested practice experience, previous certification by the American Board of Sleep Medicine, or formal Sleep Medicine fellowship training. The 2011 exam was the last administration in which candidates who had not previously been admitted could take it without completion of formal Sleep Medicine fellowship training. As expected, the number of candidates admitted to the 2011 examination through the practice experience pathway increased, and the overall scores of these candidates were on average lower than the other candidates. Consequently, the pass rate for all first takers of the 2011 examination (65%) was lower than that observed from the 2009 examination (78%) and the 2007 examination (73%). For each administration, candidates admitted through the fellowship training pathway scored the highest; over 90% of them passed the 2011 and 2009 examinations

The Utility of a Portable Sleep Monitor to Diagnose Sleep-Disordered Breathing in a Pediatric Population

BACKGROUND: Central and/or obstructive sleep-disordered breathing (SDB) in children represents a spectrum of abnormal breathing during sleep. SDB is diagnosed using the gold standard, overnight polysomnography (PSG). The limited availability and access to PSG prevents its widespread use, resulting in significant delays in diagnosis and treatment of SDB. As such, portable sleep monitors are urgently needed

The Utility of a Portable Sleep Monitor to Diagnose Sleep-Disordered Breathing in a Pediatric Population

BACKGROUND: Central and/or obstructive sleep-disordered breathing (SDB) in children represents a spectrum of abnormal breathing during sleep. SDB is diagnosed using the gold standard, overnight polysomnography (PSG). The limited availability and access to PSG prevents its widespread use, resulting in significant delays in diagnosis and treatment of SDB. As such, portable sleep monitors are urgently needed.OBJECTIVE: To evaluate the utility of a commercially available portable sleep study monitor (PSS-AL) (ApneaLink, ResMed, USA) to diagnose SDB in children.METHODS: Children referred to a pediatric sleep facility were simultaneously monitored using the PSS-AL monitor and overnight PSG. The apnea-hypopnea index (AHI) was calculated using the manual and autoscoring function of the PSS-AL, and PSG. Sensitivity and specificity were compared with the manually scored PSS-AL and PSG. Pearson correlations and Bland-Altman plots were constructed.RESULTS: Thirty-five children (13 female) completed the study. The median age was 11.0 years and the median body mass index z-score was 0.67 (range −2.3 to 3.8). SDB was diagnosed in 17 of 35 (49%) subjects using PSG. The AHI obtained by manually scored PSS-AL strongly correlated with the AHI obtained using PSG (r=0.89; Pud_less_than0.001). Using the manually scored PSS-AL, a cut-off of AHI of >5 events/h had a sensitivity of 94% and a specificity of 61% to detect any SDB diagnosed by PSG.CONCLUSIONS: Although PSG is still recommended for the diagnosis of SDB, the ApneaLink sleep monitor has a role for triaging children referred for evaluation of SDB, but has limited ability to determine the nature of the SDB.Peer Reviewe

A simple management option for chronically impacted sharp tracheobronchial foreign bodies in children

Abstract Distally impacted chronic tracheobronchial sharp foreign bodies in children are a management challenge that presents with clinical subtlety and extreme variability. The use of image guided techniques, imaginative instrumentation, tracheotomy, thoracotomy, and even extracorporeal membrane oxygneation have been reported. Endoscopy is made difficult by the distal location, inflammatory reaction with granulation tissue formation, and bleeding obscuring the foreign body. Our aim is to describe our experience with two children who had removal of aspirated impacted sharp metallic foreign bodies from the distal airway using rigid bronchoscopy, preceded by maximal medical therapy

Predictors of failure of DISE-directed adenotonsillectomy in children with sleep disordered breathing

Abstract Background Adenotonsillectomy (AT) is the most commonly performed procedure for sleep disordered breathing (SDB) in pediatrics. However, 20-40% of patients will have persistent signs and symptoms of SDB after AT. Drug-induced sleep endoscopy (DISE) has the potential to individualize surgical treatments and avoid unnecessary or unsuccessful surgeries. The objective of this study was to determine the predictors of failure of DISE-directed adenoidectomy and/or tonsillectomy in otherwise healthy children with SDB. Methods We retrospectively reviewed a prospective database of children who presented with SDB. All patients underwent preoperative pulse oximetry (PO), followed by DISE with T ± A, The variables documented included demographics, ethnicity, co-morbidities, family history, McGill Oximetry Score (MOS) on PO, as well as findings of collapse and or obstruction on DISE and symptom resolution based on modified Pediatric Sleep Questionnaire (PSQ). The primary outcome was the independent predictors of treatment failure based on multivariate binary logistic regression. Results Three hundred eighty-two patients satisfied the inclusion criteria. Based on post-operative modified PSQ, SDB resolved in 259 patients (68%), whereas 123 (32%) had persistent symptoms. On bivariate analysis, neuropsychiatric diagnosis (r = 0.286, p = 0.042), history of sleepwalking or enuresis (r = 0.103, p = 0.044), MOS (r = 0.123, p = 0.033), presence of DNS (r = 0.107, p = 0.036), and presence of laryngomalacia (r = 0.122, p = 0.017) all positively correlated with treatment failure. Small tonsil size on DISE correlated with treatment failure (r = −0.180, p < 0.001). Multivariate analysis identified age greater than 7 years (OR = 1.799, [95% CI 1.040–3.139], p = 0.039), obesity (OR = 2.032, [95% CI 1.043–3.997], p = 0.040), chronic rhinitis (OR = 1.334, [95% CI 1.047–1.716], p = 0.025), deviated nasal septum (OR = 1.745, [95% CI 1.062–2.898], p = 0.031) and tonsil size (OR = 0.575, [95% CI 0.429–0.772], p < 0.01) as independent predictors of treatment failure. Conclusions Obese, asthmatic, and children older than seven years are at increased risk of treatment failure after DISE-directed AT. Several DISE findings can independently predict AT failure, including tonsil size, degree of chronic rhinitis, and the presence of a deviated nasal septum, and can be addressed at a second stage. Further research is needed into the role of DISE in surgically naïve patients with SDB, and to compare DISE-directed surgery with the current standard of care

Trends in Diagnosing Obstructive Sleep Apnea in Pediatrics

Obstructive sleep apnea in children has been linked with behavioral and neurocognitive problems, impaired growth, cardiovascular morbidity, and metabolic consequences. Diagnosing children at a young age can potentially prevent significant morbidity associated with OSA. Despite the importance of taking a comprehensive sleep history and performing thorough physical examination to screen for signs and symptoms of OSA, these findings alone are inadequate for definitively diagnosing OSA. In-laboratory polysomnography (PSG) remains the gold standard of diagnosing pediatric OSA. However, there are limitations related to the attended in-lab polysomnography, such as limited access to a sleep center, the specialized training involved in studying children, the laborious nature of the test and social/economic barriers, which can delay diagnosis and treatment. There has been increasing research about utilizing alternative methods of diagnosis of OSA in children including home sleep testing, especially with the emergence of wearable technology. In this article, we aim to look at the presentation, physical exam, screening questionnaires and current different modalities used to aid in the diagnosis of OSA in children