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Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease (ZEAL Study): A Protocol for Randomized Controlled Trials

Background: Sleep disorders are one of the most frequent non-motor symptoms of Parkinson's disease (PD), and the efficacy of dopaminergic agents remains controversial. Clinical randomized control trials for the treatment of sleep disorders in PD are limited. Zonisamide (1,2-benzisoxazole-3-meth...

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Autores principales: Kataoka, Hiroshi, Isogawa, Masahiro, Inoue, Takashi, Hasebe, Miyoko, Takashima, Ryuzo, Kasama, Shu, Nanaura, Hitoki, Kiriyama, Takao, Kasahara, Masato, Sugie, Kazuma
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8713296/
https://www.ncbi.nlm.nih.gov/pubmed/34970203
http://dx.doi.org/10.3389/fneur.2021.741307
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author Kataoka, Hiroshi
Isogawa, Masahiro
Inoue, Takashi
Hasebe, Miyoko
Takashima, Ryuzo
Kasama, Shu
Nanaura, Hitoki
Kiriyama, Takao
Kasahara, Masato
Sugie, Kazuma
author_facet Kataoka, Hiroshi
Isogawa, Masahiro
Inoue, Takashi
Hasebe, Miyoko
Takashima, Ryuzo
Kasama, Shu
Nanaura, Hitoki
Kiriyama, Takao
Kasahara, Masato
Sugie, Kazuma
author_sort Kataoka, Hiroshi
collection PubMed
description Background: Sleep disorders are one of the most frequent non-motor symptoms of Parkinson's disease (PD), and the efficacy of dopaminergic agents remains controversial. Clinical randomized control trials for the treatment of sleep disorders in PD are limited. Zonisamide (1,2-benzisoxazole-3-methanesulfonamide) improved motor symptoms and wearing-off in patients with PD. Patients with PD were reported to have dream-enacting behavior that was resolved after treatment with zonisamide. This study aimed to verify the safety and efficacy of zonisamide for sleep disorders and rapid eye movement (REM) sleep behavioral disorders using a mobile two-channel electroencephalography (EEG)/electrooculography (EOG) recording system. Methods and Analysis: The present study is a randomized placebo-controlled trial to determine the efficacy of zonisamide for sleep disorders in patients with PD. This study was designed to be single-blind, but the subject allocation is randomized by an independent allocation manager via computer-generated block randomization. The subjects in the treatment group took zonisamide (25 mg per day) before bedtime for 28 days. The sleep index is analyzed using a portable EEG/EOG recording system collected on two consecutive nights within 7 days prior to the intervention and reobtained on one night within 2 days after the 28-day administration of zonisamide. The amount of change in sleep efficiency before and after the 28-day administration will be compared between the zonisamide treatment group and placebo group concerning the primary endpoint. As for the secondary endpoint, the change in the ratio of other sleep parameters, including REM sleep without atonia, or sleep architecture will be evaluated. Ethics and Dissemination: The protocol was approved by the Nara Medical University Certified Review Board (CRB5200002). The trial was notified and registered with the Japan Registry of Clinical Trials (jRCTs051200160). Written informed consent will be obtained from every participant using informed consent approved by the CRB. The results of this trial will be disseminated through peer-reviewed scientific journals.
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spelling pubmed-87132962021-12-29 Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease (ZEAL Study): A Protocol for Randomized Controlled Trials Kataoka, Hiroshi Isogawa, Masahiro Inoue, Takashi Hasebe, Miyoko Takashima, Ryuzo Kasama, Shu Nanaura, Hitoki Kiriyama, Takao Kasahara, Masato Sugie, Kazuma Front Neurol Neurology Background: Sleep disorders are one of the most frequent non-motor symptoms of Parkinson's disease (PD), and the efficacy of dopaminergic agents remains controversial. Clinical randomized control trials for the treatment of sleep disorders in PD are limited. Zonisamide (1,2-benzisoxazole-3-methanesulfonamide) improved motor symptoms and wearing-off in patients with PD. Patients with PD were reported to have dream-enacting behavior that was resolved after treatment with zonisamide. This study aimed to verify the safety and efficacy of zonisamide for sleep disorders and rapid eye movement (REM) sleep behavioral disorders using a mobile two-channel electroencephalography (EEG)/electrooculography (EOG) recording system. Methods and Analysis: The present study is a randomized placebo-controlled trial to determine the efficacy of zonisamide for sleep disorders in patients with PD. This study was designed to be single-blind, but the subject allocation is randomized by an independent allocation manager via computer-generated block randomization. The subjects in the treatment group took zonisamide (25 mg per day) before bedtime for 28 days. The sleep index is analyzed using a portable EEG/EOG recording system collected on two consecutive nights within 7 days prior to the intervention and reobtained on one night within 2 days after the 28-day administration of zonisamide. The amount of change in sleep efficiency before and after the 28-day administration will be compared between the zonisamide treatment group and placebo group concerning the primary endpoint. As for the secondary endpoint, the change in the ratio of other sleep parameters, including REM sleep without atonia, or sleep architecture will be evaluated. Ethics and Dissemination: The protocol was approved by the Nara Medical University Certified Review Board (CRB5200002). The trial was notified and registered with the Japan Registry of Clinical Trials (jRCTs051200160). Written informed consent will be obtained from every participant using informed consent approved by the CRB. The results of this trial will be disseminated through peer-reviewed scientific journals. Frontiers Media S.A. 2021-12-10 /pmc/articles/PMC8713296/ /pubmed/34970203 http://dx.doi.org/10.3389/fneur.2021.741307 Text en Copyright © 2021 Kataoka, Isogawa, Inoue, Hasebe, Takashima, Kasama, Nanaura, Kiriyama, Kasahara and Sugie. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Kataoka, Hiroshi
Isogawa, Masahiro
Inoue, Takashi
Hasebe, Miyoko
Takashima, Ryuzo
Kasama, Shu
Nanaura, Hitoki
Kiriyama, Takao
Kasahara, Masato
Sugie, Kazuma
Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease (ZEAL Study): A Protocol for Randomized Controlled Trials
title Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease (ZEAL Study): A Protocol for Randomized Controlled Trials
title_full Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease (ZEAL Study): A Protocol for Randomized Controlled Trials
title_fullStr Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease (ZEAL Study): A Protocol for Randomized Controlled Trials
title_full_unstemmed Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease (ZEAL Study): A Protocol for Randomized Controlled Trials
title_short Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease (ZEAL Study): A Protocol for Randomized Controlled Trials
title_sort zonisamide for the efficacy of sleep abnormality in parkinson's disease (zeal study): a protocol for randomized controlled trials
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8713296/
https://www.ncbi.nlm.nih.gov/pubmed/34970203
http://dx.doi.org/10.3389/fneur.2021.741307
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