Aim To evaluate the effectiveness of pharmacological interventions for managing non‐respiratory sleep disturbances in children with neurodisabilities. Method We performed a systematic review and meta‐analyses of randomized controlled trials ( RCT s). We searched 16 databases, grey literature, and reference lists of included papers up to February 2017. Data were extracted and assessed for quality by two researchers (B.B., C.M., G.S., A.S., A.P.). Results Thirteen trials were included, all evaluating oral melatonin. All except one were at high or unclear risk of bias. There was a statistically significant increase in diary‐reported total sleep time for melatonin compared with placebo (pooled mean difference 29.6min, 95% confidence interval [ CI ] 6.9–52.4, p =0.01). Statistical heterogeneity was high (97%). For the single RCT with low risk of bias, the unadjusted mean difference in total sleep time was 13.2 minutes (95% CI −13.3 to 39.7) favouring melatonin, while the mean difference adjusted for baseline total sleep time was statistically significant (22.4min, 95% CI 0.5–44.3, p =0.04). Adverse event profile suggested that melatonin was well‐tolerated. Interpretation There is a paucity of evidence on managing sleep disturbances in children with neurodisabilities, and it is mostly of limited scope and poor quality. There is evidence of the benefit and safety of melatonin compared with placebo, although the extent of this benefit is unclear. What this paper adds Melatonin for the management of non‐respiratory sleep disturbances in children with neurodisabilities was well tolerated with minimal adverse effects. The extent of benefit and which children might benefit most from melatonin use is uncertain. Benefit may be greatest in those with autism spectrum disorder; however, this finding should be interpreted with caution.
Background There is uncertainty about the most appropriate ways to manage non-respiratory sleep disturbances in children with neurodisabilities (NDs). Objective To assess the clinical effectiveness and safety of NHS-relevant pharmacological and non-pharmacological interventions to manage sleep disturbance in children and young people with NDs, who have non-respiratory sleep disturbance. Data sources Sixteen databases, including The Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE, were searched up to February 2017, and grey literature searches and hand-searches were conducted. Review methods For pharmacological interventions, only randomised controlled trials (RCTs) were included. For non-pharmacological interventions, RCTs, non-randomised controlled studies and before-and-after studies were included. Data were extracted and quality assessed by two researchers. Meta-analysis and narrative synthesis were undertaken. Data on parents’ and children’s experiences of receiving a sleep disturbance intervention were collated into themes and reported narratively. Results Thirty-nine studies were included. Sample sizes ranged from 5 to 244 participants. Thirteen RCTs evaluated oral melatonin. Twenty-six studies (12 RCTs and 14 before-and-after studies) evaluated non-pharmacological interventions, including comprehensive parent-directed tailored (n = 9) and non-tailored (n = 8) interventions, non-comprehensive parent-directed interventions (n = 2) and other non-pharmacological interventions (n = 7). All but one study were reported as having a high or unclear risk of bias, and studies were generally poorly reported. There was a statistically significant increase in diary-reported total sleep time (TST), which was the most commonly reported outcome for melatonin compared with placebo [pooled mean difference 29.6 minutes, 95% confidence interval (CI) 6.9 to 52.4 minutes; p = 0.01]; however, statistical heterogeneity was extremely high (97%). For the single melatonin study that was rated as having a low risk of bias, the mean increase in TST was 13.2 minutes and the lower CI included the possibility of reduced sleep time (95% CI –13.3 to 39.7 minutes). There was mixed evidence about the clinical effectiveness of the non-pharmacological interventions. Sixteen studies included interventions that investigated the feasibility, acceptability and/or parent or clinician views of sleep disturbance interventions. The majority of these studies reported the ‘family experience’ of non-pharmacological interventions. Limitations Planned subgroup analysis was possible in only a small number of melatonin trials. Conclusions There is some evidence of benefit for melatonin compared with placebo, but the degree of benefit is uncertain. There are various types of non-pharmacological interventions for managing sleep disturbance; however, clinical and methodological heterogeneity, few RCTs, a lack of standardised outcome measures and risk of bias means that it is not possible to draw conclusions with regard to their effectiveness. Future work should include the development of a core outcome, further evaluation of the clinical effectiveness and cost-effectiveness of pharmacological and non-pharmacological interventions and research exploring the prevention of, and methods for identifying, sleep disturbance. Research mapping current practices and exploring families’ understanding of sleep disturbance and their experiences of obtaining help may facilitate service provision development. Study registration This study is registered as PROSPERO CRD42016034067. Funding The National Institute for Health Research Health Technology Assessment programme.
Existing evidence on non-pharmacological interventions to manage sleep disturbance in children with neurodisabilities is predominately of poor quality. Most included studies evaluated parent-directed interventions of varying content and intensity. There was very little consistency between studies in the outcome measures used. There is some evidence that parent-directed interventions may improve child outcomes.
of Human Occupation focus on how to motivate, structure and perform one's occupation to achieve balance. The occupation-based sleep program focuses on strategies to maximize occupational balance through lifestyle coaching to promote patterning of occupation into routine and lifestyle. This study aims to evaluate the effectiveness of the occupation-based sleep program on sleep pattern, mood and occupational balance among community dwelling adults presents with insomnia. This study is a quasi-experimental design which compares therapy outcomes at pre, post and follow up, between intervention group and treatment-as-usual group. A total of 35 clients were recruited with 20 from intervention group and 15 from treatment-as-usual group. There is no significant different on baseline characteristic between groups. When compared with treatment-as-usual group, there's significant improvement on sleep efficiency at post intervention. In addition, intervention group had significant improvement in insomnia severity, sleep efficiency, occupational balance and mood at follow up. In summary, occupation-based sleep interventions aim to 1) minimize influence of bodily function on sleep; 2) promote environment conductive to sleep; and 3) restructure activity with a focus on occupational balance. Further development of sleep management from an occupational therapy perspective will strengthen the role of sleep within clinical practice, education, and research domains.
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