Prescriber Acceptability of a Direct-to-Patient Intervention for Benzodiazepine Receptor Agonist Deprescribing and Behavioural Management of Insomnia in Older Adults.

Behavioural treatments are recommended first-line for insomnia, but long-term benzodiazepine receptor agonist (BZRA) use remains common and engaging patients in a deprescribing consultation is challenging. Few deprescribing interventions directly target patients. Prescribers' support of patient-targeted interventions may facilitate their uptake. Recently assessed in the Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study, Sleepwell (mysleepwell.ca) was developed as a direct-to-patient behaviour change intervention promoting BZRA deprescribing and non-pharmacological insomnia management. BZRA prescribers of YAWNS NB participants were invited to complete an online survey assessing the acceptability of Sleepwell as a direct-to-patient intervention. The survey was developed using the seven construct components of the theoretical framework of acceptability (TFA) framework. Respondents (40/250, 17.2%) indicated high acceptability, with positive responses per TFA construct averaging 32.3/40 (80.7%). Perceived as an ethical, credible, and useful tool, Sleepwell also promoted prescriber-patient BZRA deprescribing engagements (11/19, 58%). Prescribers were accepting of Sleepwell and supported its application as a direct-to-patient intervention.

Focus Groups to Inform User-Centered Development of an eHealth Sleep Intervention for Adolescents: Perspectives of Youth with Insomnia Symptoms, with and without Pain.

INTRODUCTION: Adolescence is a developmental stage that often coincides with increasing sleep problems. Focus groups were conducted to inform development of an adolescent eHealth sleep intervention by exploring opinions about (1) healthy sleep practices, and (2) using an eHealth intervention. METHODS: Adolescents 14-18 years old experiencing symptoms of insomnia based on the Insomnia Sleep Index, with and without recurrent pain, and associated stakeholders (i.e., parents, school personnel, and health care providers) were recruited. Across six online focus groups, 24 adolescents with insomnia participated (14 pain-free, 10 with recurrent pain; 10 male, 14 female). Across seven online focus groups, 22 stakeholders participated, including 8 parents, 9 school professionals, and 5 health care providers (10 male, 8 female). Using a content analysis, subthemes were induced from transcripts. RESULTS: Most healthy sleep practices were perceived as reasonable for adolescents to implement, except avoiding technology before bed and using bedrooms only for sleep. Three primary barriers to sleep practices were identified, including a variable schedule due to lifestyle factors, technology at night, and academics interfering with sleep, and only in the pain group, the barrier related to pain was identified. Content addressing adolescent-specific barriers was considered important to include in a sleep intervention. Desirable eHealth components included interactive features, videos, audio, and pictures to present information. A common barrier to using an eHealth sleep intervention was the program feeling too academic, with accessibility of the sleep information and strategies as a common facilitator. CONCLUSIONS: This research represents the first step in a user-centered approach to developing an adolescent eHealth sleep intervention. These results provide insights from a range of perspectives on guiding adolescents to follow healthy sleep practices. Next, these findings will be integrated in the development of an eHealth intervention for adolescents with and without recurrent pain.

Effectiveness and cost analysis of methods used to recruit older adult sedative users to a deprescribing randomized controlled trial during the COVID-19 pandemic.

Background: Recruitment to clinical trials is a challenge for researchers that became more pronounced because of COVID-19 public health protective measures, especially with respect to studies enrolling older adults. We completed an effectiveness and cost analysis of the recruitment methods used in The Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study, a randomized controlled trial of a deprescribing intervention that recruited older adults with chronic use of sedatives during the pandemic. Methods: Study recruitment began during the COVID-19 pandemic. Strategies included random digit dialing (RDD), a targeted mail campaign and advertising through newspapers, online platforms (Google and Facebook), and television. Other awareness raising and recruitment strategies involved seniors' organizations, pharmacies, television news stories, and referrals. Recruitment effectiveness and cost analysis involved enrollment rate (ER), cost per randomized participant (CPRP), fractional cost (FC), fractional enrollment (FE), fractional enrollment-cost ratio (FEC), and efficacy index (EI) calculations. Results: There were 1295 interested older adults with 594 randomized into the study for an enrollment rate of 46%. The efficacy index (EI) was highest for Facebook ads (EI = 0.683) followed by television (EI = 0.426), and newsprint ads (EI = 0.298). The cost of RDD was highest per randomized participant at $1117.90 and produced the lowest EI (0.013). Conclusion: Facebook ads had the best efficacy index for recruiting older adults to the YAWNS NB study during the COVID-19 pandemic and television ads produced the most enrollments. RDD was expensive and yielded few recruits. Recruitment costs can be significant for recruiting community-dwelling older adults. This experience can inform recruitment strategy and budget development for future community studies enrolling older adults, especially in the context of the COVID-19 pandemic.

A protocol for a randomized controlled trial comparing Sleepwell, EMPOWER, and treatment-as-usual for benzodiazepine receptor agonist discontinuation in older adults: the your answers when needing sleep in New Brunswick (YAWNS NB) study.

Background: Chronic benzodiazepine receptor agonist (BZRA) use among older adults is a public health concern given cognitive and physical risks. One in four older adults in New Brunswick, Canada, is a long-term user of BZRAs. Previous studies using a direct-to-patient approach as the primary intervention target have shown promise in reducing BZRA use. The Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study aims to reduce the long-term use of BZRAs in older adults and increase the use of cognitive behavioural therapy for insomnia (CBTi), which is the recommended first line treatment. Methods: The trial (ClinicalTrials.gov registration NCT04406103) is a three arm, open-label, parallel randomized controlled trial in NB, Canada. Eligible participants 65 years and older using BZRAs long-term will be randomly allocated to: the Eliminating Medications through Patient Ownership of End Results (EMPOWER) information package group; the Sleepwell information package group; or treatment-as-usual (TAU). Information packages will be mailed via Canada Post. The primary outcome of BZRA discontinuation at 6 months will be compared across groups. Secondary outcomes include participants with ≥25% BZRA dose reduction, and switching to newly prescribed alternate sedative-hypnotics. Several exploratory outcomes will also be examined. Discussion: Targeting participants with information packages informing them of appropriate use, dangers, and approaches to reducing BZRA use and increasing CBTi use may be beneficial in a region of Canada with the highest rate of chronic BZRA use in older adults. Comparing information packages and TAU will provide insights into the effectiveness of direct-to-patient interventions for BZRA reduction.

Even a Mild Sleep Restriction Can Impact Daytime Functioning in Children with ADHD and Their Typically Developing Peers.

OBJECTIVES/BACKGROUND: Correlational studies show that short sleep is associated with negative daytime outcomes in school-aged children, but there are few experimental sleep manipulation studies to assess whether this is a causal relation. The aim of this study was to determine the impact of mild, cumulative sleep restriction on daytime functioning of typically developing (TD) children and children with attention-deficit/hyperactivity disorder (ADHD). PARTICIPANTS: A total of 36 school-aged children (n = 18 TD; n = 18 ADHD), aged 6-11 years participated. METHODS: Children participated in two sleep conditions (order counter-balanced). The Restricted condition required a 1 h reduction of time in bed for one week, and the Controlled Typical condition was based on participant's average baseline sleep. At the end of each condition, participants attended the sleep lab for overnight polysomnography and daytime functioning assessments. RESULTS: Children successfully reduced time in bed by ~1 h. Due to compensatory changes, total sleep time (TST) was reduced by only ~20 min, as children fell asleep faster and spent less time awake after sleep onset during the Restricted compared to Controlled Typical condition. Many daytime functions were not affected by this very mild sleep restriction, however, both groups showed significant changes in performance on an objective attention task and on a parent-rated emotional lability measure after six nights of minimal reductions in TST. There were no significant differences between groups. CONCLUSIONS: Results suggest that a very mild sleep restriction can affect children's attention and emotional regulation, even with evidence of compensatory sleep mechanisms.

Sleep Variables as Predictors of Treatment Effectiveness and Side Effects of Stimulant Medication in Newly Diagnosed Children with Attention-Deficit/Hyperactivity Disorder.

OBJECTIVE: There is a growing body of research on the impact of stimulant medication on sleep in children with attention-deficit/hyperactivity disorder (ADHD). Negative sleep side effects are a common reason for nonadherence or for discontinuing a course of treatment. However, there is no published evidence as to whether pretreatment sleep can predict responses to treatment and the emergence of side effects. METHOD: In this study, baseline sleep variables were used to predict therapeutic effect (i.e., reduction of ADHD symptoms) and side effects (both sleep and global side effects) in a sample of newly diagnosed, medication-naive children (n = 50). RESULTS: The results of hierarchical regression analysis showed that parent-reported shorter sleep duration before medication treatment significantly predicted better response to treatment, independent of pretreatment ADHD symptoms. Baseline sleep features did not significantly predict global (nonsleep) side effects but did predict increased sleep side effects during treatment. CONCLUSION: These results indicate that baseline sleep variables may be helpful in predicting therapeutic response to medication and sleep disturbance as a side effect of stimulant medication.

The Effects of Extended-Release Stimulant Medication on Sleep in Children with ADHD.

OBJECTIVE: Although stimulant medications, such as methylphenidate hydrochloride (MPH), are effective at reducing the core symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD), they may also disrupt children's sleep. This study aimed to investigate the acute impact of extended-release MPH on sleep using both actigraphy and polysomnography (PSG). METHOD: Participants were 26 medication-naïve newly and rigorously diagnosed children with ADHD (23 males; 3 females) with a mean age of 8 years, 8 months (SD = 24.5mos) who were enrolled in a clinically-administered crossover medication trial with 2 conditions: 2 weeks of placebo and 2 weeks of MPH treatment. The effect of condition on sleep variables as measured by actigraphy (primary outcome) and PSG (secondary outcome) was analyzed using repeated measures MANOVAs. RESULTS: Based on actigraphy data, total sleep time was significantly reduced by 30 minutes and sleep onset latency was significantly increased by 30 minutes in the MPH condition compared to the placebo condition (p<0.001). No differences were found in sleep efficiency. No statistically significant differences were found for the same variables assessed by PSG; however, the means were in the same direction as the actigraphy data. There was a significant increase in the relative percentage of stage N3 sleep by 3.2% during MPH treatment (p<0.05). CONCLUSIONS: Increased sleep onset latency resulting in reduced total sleep time, which has been linked to poorer daytime functioning, is a potential adverse effect of stimulant medication which may require management to optimize outcome.

OBJECTIF: Bien que les médicaments stimulants comme le chlorhydrate de méthylphénidate (MPH) soient efficaces pour réduire les principaux symptômes du trouble de déficit de l'attention avec hyperactivité (TDAH), ils peuvent également perturber le sommeil des enfants. La présente étude visait à rechercher l'effet précis du MPH à libération prolongée sur le sommeil à l'aide d'une actigraphie et d'une polysomnographie (PSG). MÉTHODE: Les participants étaient 26 enfants naïfs de médicaments ayant nouvellement et rigoureusement reçu un diagnostic de TDAH (23 garçons; 3 filles) d'âge moyen de 8 ans et 8 mois (ET = 24,5 mois) qui étaient inscrits dans un essai croisé cliniquement administré sur la médication selon 2 conditions: 2 semaines de placebo et deux semaines de traitement par MPH. L'effet de la condition sur les variables du sommeil telles que mesurées par l'actigraphie (résultat principal) et la PSG (résultat secondaire) a été analysé par des mesures répétées MANOVA. RÉSULTATS: Selon les données de l'actigraphie, le temps de sommeil total était significativement réduit de 30 minutes et la latence d'endormissement était significativement accrue de 30 minutes dans la condition MPH comparativement à la condition placebo (p < 0,001). Aucune différence n'a été notée pour l'efficacité du sommeil. Aucune différence statistiquement significative n'a été observée pour les mêmes variables évaluées par la PSG; cependant, les moyennes suivaient la même direction que les données de l'actigraphie. Il y avait une augmentation significative de 3,2 % du pourcentage relatif au stade N3 du sommeil durant le traitement par MPH (p < 0,05). CONCLUSIONS: La latence d'endormissement accrue entraînant un temps de sommeil total réduit, qui est lié à un mauvais fonctionnement de jour, est un effet indésirable potentiel des médicaments stimulants, qui peut nécessiter une prise en charge afin d'optimiser le résultat.

Concordance of actigraphy with polysomnography in children with and without attention-deficit/hyperactivity disorder.

This study sought to: (1) compare actigraphy-derived estimated sleep variables to the same variables based on the gold-standard of sleep assessment, polysomnography; (2) examine whether the correlations between the measures differ between children with attention-deficit/hyperactivity disorder and typically developing children; and (3) determine whether these correlations are altered when children with attention-deficit/hyperactivity disorder are treated with medication. Participants (24 attention-deficit/hyperactivity disorder; 24 typically developing), aged 6-12 years, completed a 1-week baseline assessment of typical sleep and daytime functioning. Following the baseline week, participants in the attention-deficit/hyperactivity disorder group completed a 4-week blinded randomized control trial of methylphenidate hydrochloride, including a 2-week placebo and 2-week methylphenidate hydrochloride treatment period. At the end of each observation (typically developing: baseline; attention-deficit/hyperactivity disorder: baseline, placebo and methylphenidate hydrochloride treatment), all participants were invited to a sleep research laboratory, where overnight polysomnography and actigraphy were recorded concurrently. Findings from intra-class correlations and Bland-Altman plots were consistent. Actigraphy was found to provide good estimates (e.g. intra-class correlations >0.61) of polysomnography results for sleep duration for all groups and conditions, as well as for sleep-onset latency and sleep efficiency for the typically developing group and attention-deficit/hyperactivity disorder group while on medication, but not for the attention-deficit/hyperactivity disorder group during baseline or placebo. Based on the Bland-Altman plots, actigraphy tended to underestimate for sleep duration (8.6-18.5 min), sleep efficiency (5.6-9.3%) and sleep-onset latency, except for attention-deficit/hyperactivity disorder during placebo in which actigraphy overestimated (-2.1 to 6.3 min). The results of the current study highlight the importance of utilizing a multimodal approach to sleep assessment in children with attention-deficit/hyperactivity disorder.

The role of daytime sleepiness in psychosocial outcomes after treatment for obstructive sleep apnea.

We investigated the role of daytime sleepiness and sleep quality in psychosocial outcomes of patients with obstructive sleep apnea (OSA) treated with continuous positive airway pressure (CPAP). Thirty-seven individuals with moderate to severe OSA and compliant with CPAP treatment for at least 3 months were compared to 27 age- and education-matched healthy controls. The OSA group and the control group were studied with overnight polysomnography (PSG) and compared on measures of daytime sleepiness (Epworth Sleepiness Scale), sleep quality (Pittsburg Sleep Quality Index), mood (Beck Depression Inventory, Profile of Mood States), and functional outcomes (Functional Outcomes of Sleep Questionnaire). After CPAP treatment, the OSA group improved on sleep quality and sleepiness. As a group, they did not differ from controls on sleep architecture after CPAP. The OSA group also showed significant improvements in functional outcomes and was comparable to controls on mood and functional outcomes. Persistent difficulties included lowered activity level and residual sleepiness in some individuals. Sleepiness was found to be a significant predictor of mood and affective states, while both sleepiness and sleep quality predicted functional outcomes. These results highlight the importance of assessment and intervention targeting psychosocial functioning and sleepiness in individuals with OSA after treatment.

Executive function in patients with obstructive sleep apnea treated with continuous positive airway pressure.

Obstructive sleep apnea (OSA) is characterized by disrupted breathing and hypoxemia during sleep, daytime sleepiness, and changes in cognition and mood. One important question is regarding the reversibility of cognitive deficits after treatment with continuous positive airway pressure (CPAP). Here, we report the outcomes of CPAP treatment as measured by tests of attention and executive function. Thirty-seven individuals with moderate to severe OSA and compliant on CPAP treatment were studied with working memory tasks, neuropsychological testing, and overnight polysomnographic sleep study and compared to 27 healthy controls. CPAP improved the respiratory disturbance index, minimum and mean oxygen saturation (SpO2), subjective sleep quality, and daytime sleepiness ratings compared to pre-treatment values. In terms of current neurocognitive function, treated individuals with OSA performed at a comparable level to controls on basic working memory storage functions but still showed a significant reduction on tests of working memory requiring the central executive. The OSA group also performed worse on neuropsychological measures of complex attention, executive function, and psychomotor speed. While CPAP is an effective treatment for OSA in terms of ameliorating breathing disruption and oxygen desaturation during sleep, as well as daytime sleepiness, some cognitive deficits may be more resistant to treatment.