ArticleBMJ open2021
FLUID study: study protocol for an open-label, single-centre pilot study to investigate the efFect of Lemborexant on sleep management in Japanese sUbjects aged 50 years and older with Insomnia Disorder.
Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed, 14 citations in OpenAlex.
- Assessing the Real-World, Long-Term Impact of Lemborexant on Sleep Quality in a Home-Based Clinical Study.Nature and science of sleep · 2024Trial
- Diffusion tensor image analysis along the perivascular space (DTI-ALPS): redefining its interpretation and role.Japanese journal of radiology · 2026Review
- The Prevalence of Sleep Disorders in Populations with Glymphatic Dysfunction: A Systematic Review and Meta-Analysis.Biology · 2026Review
- Effect of lemborexant on sleep-wake state discrepancy in participants with insomnia disorder.Psychopharmacology · 2026Article
- Contribution of white matter microstructure to diffusion tensor image analysis along perivascular space in obstructive sleep apnea.Japanese journal of radiology · 2025Article
- MR Imaging Indices for Brain Interstitial Fluid Dynamics and the Effects of Orexin Antagonists on Sleep.Magnetic resonance in medical sciences : MRMS : an official journal of Japan Society of Magnetic Resonance in Medicine · 2025Article
- Gut Microbiome Composition Changes During Insomnia Treatment with Lemborexant.Nature and science of sleep · 2025Article
- Interstitial Fluidopathy of the Central Nervous System: An Umbrella Term for Disorders with Impaired Neurofluid Dynamics.Magnetic resonance in medical sciences : MRMS : an official journal of Japan Society of Magnetic Resonance in Medicine · 2024Article
- DTI-ALPS: An MR biomarker for motor dysfunction in patients with subacute ischemic stroke.Frontiers in neuroscience · 2023Article
- Diffusion-weighted image analysis along the perivascular space (DWI-ALPS) for evaluating interstitial fluid status: age dependence in normal subjects.Japanese journal of radiology · 2022Article
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 ANALYSIS: This 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 DISSEMINATION: The 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 NUMBER: jRCTs041210024.
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