FLUID study: study protocol for an open-label, single-center pilot study to investigate the effect of Lemborexant on sleep management in Japanese subjects aged 50 and over with insomnia

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BMJ Open. November 26, 2021; 11 (11): e054885. doi: 10.1136 / bmjopen-2021-054885.

ABSTRACT

INTRODUCTION: Bidirectional associations have been reported between sleep disturbances and cognitive impairment, including Alzheimer’s disease, and accumulation of amyloid beta-peptide (Aβ). These relationships can be explained by the glymphatic system, which acts as a waste drainage system in the brain. Since it is suggested that interstitial fluid dynamics increase during sleep, Aβ clearance may be influenced by sleep disturbance or deprivation. We hypothesized that the use of lemborexant, an orexin receptor antagonist, to improve the quality of sleep would also improve the function of the glymphatic system. We plan to examine the effect of lemborexant on sleep quality and the glymphatic system in patients with insomnia.

METHODS AND ANALYSIS: This pilot study is designed as an open, single-arm, single-center trial. Thirty patients aged 50 and over suffering from insomnia will be recruited. Participants will take lemborexant (5 mg) at bedtime for 12 weeks and undergo a home sleep study at baseline and at weeks 4 and 12, as well as MRI scans to assess the lymphatic system at baseline and at week 12. primary outcome will be changes in objective sleep parameters assessed using a sleep monitoring system. The secondary results will be changes in the subjective parameters of sleep. The relationships between changes in sleep parameters and the glymphatic system will be assessed using image analysis of the diffusion tensor along the perivascular space, called the ALPS index. The sleep parameters and the ALPS index will be analyzed using a paired t test or Pearson’s correlation coefficient.

ETHICS AND DISSEMINATION: The study protocol has been approved by the Certified Examination Board of Nagoya University. The results of this research will be published in peer-reviewed journals and presented at local, national and international conferences.

TEST REGISTRATION NUMBER: jRCTs041210024.

PMID: 34836909 | DOI: 10.1136 / bmjopen-2021-054885


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