IntroductionBidirectional associations have been reported between sleep disturbance and both cognitive impairment, including Alzheimer’s disease and amyloid beta-peptide (Aβ) accumulation. These relationships can be explained by the glymphatic system, which acts as a garbage drainage system in the brain. As interstitial fluid dynamics are suggested to increase during sleep, clearance of Aβ can be influenced by sleep disturbance or deprivation. We hypothesised that using lemborexant, an orexin receptor antagonist, to improve sleep quality would also improve the function of the glymphatic system. We plan to examine the effect of lemborexant on sleep quality and the glymphatic system among patients with insomnia disorder.Methods and analysisThis pilot study is designed as an open-label, single-arm, single-centre trial. Thirty patients aged 50 years and over with insomnia will be recruited. The participants will take lemborexant (5 mg) at bedtime for 12 weeks and undergo a home-based sleep study at baseline and weeks 4 and 12, as well as MRI examinations to evaluate the glymphatic system at baseline and week 12. The primary outcome will be changes in objective sleep parameters as evaluated using a sleep monitoring system. The secondary outcomes will be changes in subjective sleep parameters. The relationships between changes in sleep parameters and the glymphatic system will be evaluated using diffusion tensor image analysis along the perivascular space, which is called the ALPS-index. Sleep parameters and the ALPS-index will be analysed using a paired t-test or Pearson’s correlation coefficient.Ethics and disseminationThe study protocol was approved by Nagoya University Certified Review Board. The findings from this research will be published in peer-reviewed journals and be presented at local, national and international conferences.Trial registration numberjRCTs041210024.
Purpose Sleep state misperception, which is the discrepancy between subjective and objective sleep, is often observed in patients with depression. This phenomenon may delay the remission of depression. Previous studies have focused on the total sleep time (TST) misperception, with many of these studies using actigraphy. Thus, our study investigated depressed patients with the exploratory aim of clarifying factors associated with the sleep state misperception including the wake after sleep onset (WASO) misperception, with their objective sleep additionally evaluated by polysomnography (PSG). Patients and Methods We conducted a cross-sectional study. Before undergoing overnight PSG monitoring, 40 patients with depression completed questionnaires that included the Beck Depression Inventory (BDI), Epworth sleepiness scale, Temperament and Character Inventory, and the Pittsburgh sleep quality index. Patients were also asked to estimate their subjective sleep duration after they woke up in the morning. Based on this data, we calculated the misperception using the following formula: subjective sleep duration minus objective sleep duration. We compared each factor between negative and positive misperception groups and the multiple regression analysis was performed for TST and WASO misperception, respectively. Results Although sleep architectures, age, severity of depression and obstructive sleep apnea (OSA) exhibited differences in underestimating or overestimating the WASO, only sex differences were associated with underestimating or overestimating their total sleep time (TST). Moreover, BDI, the severity of OSA, sleep architectures (N1% and N2%), and benzodiazepine (BZD) use were significantly correlated with WASO misperception, whereas only OSA severity was significantly correlated with TST misperception. A subsequent multiple regression analysis demonstrated the BDI was independently correlated with the WASO misperception (β=0.341, p =0.049). Conclusion In clinical practice, interventions especially for OSA, and the reduction of depressive symptoms are an important method for improving patient sleep perception. Moreover, current results suggest that BZD prescriptions should be avoided as well.
Introduction In the treatment of insomnia, both subjective and objective evaluations are essential. The orexin receptor antagonist, lemborexant, has a favorable profile in terms of efficacy, acceptability, and tolerability for adults diagnosed with insomnia. To date, the long-term efficacy of lemborexant has been evaluated solely on a subjective basis, with no long-term objective measures under natural sleeping conditions. Therefore, a small, lightweight sleep electroencephalograph monitor was used to evaluate sleep objectively at home after 4 and 12 weeks of lemborexant treatment. Methods Adults and elderly subjects with insomnia disorder per DSM-5 were enrolled in an open-label, single-arm, single-center trial. Participants took lemborexant (5/10 mg) at bedtime for 12 weeks. In addition, they underwent a home-based sleep study at baseline and weeks 4 and 12. Sleep efficiency (SE), total sleep time (TST), latency to persistent sleep (LPS), and wake after sleep onset (WASO) were evaluated at home. Sleep disturbance (Pittsburgh sleep quality index: PSQI), sleepiness (Epworth sleepiness scale: ESS), and depressive symptoms (Beck depression index: BDI) were examined. Results 31 subjects completed the 4-week and 29 completed the 12-week assessments. Subjects showed significant improvements in objective SE at weeks 4 and 12 of treatment compared to untreated baseline. Objective TST tended to increase with the treatment at week 12. Mixed-effects linear analysis revealed that the poorer the sleep measures (SE, TST, LPS, and WASO) were at baseline, the more these measures improved with lemborexant. Scores of PSQI, ESS, and BDI significantly decreased (improved) with lemborexant treatment compared to those at baseline. Conclusion The findings from the analyses demonstrate objective improvement of SE with lemborexant treatment across 12 weeks and support the previously reported benefit of lemborexant using polysomnography. Support (if any)
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