Oral nicotinamide mononucleotide (NMN) to treat chronic insomnia: protocol for the multicenter, randomized, double-blinded, placebo-controlled trial

Trials

Study Protocol

Xicheng Wang¹  Xueying Li²  Junhua Li³  Yongli Li⁴  Sanping Xu⁵  Yan Huang⁶  Shaohui Liu⁷  Xiangyang Gao⁸  Qiang Zeng⁸ 

[1] Beijing Dublin International Collage, Beijing University of Technology, 100124, Beijing, China;Department of Biostatistics, Peking University First Hospital, 100034, Beijing, China;Health Management Center, Handan Central Hospital, Hebei Province, Handan, China;Health Management Center, Henan Provincial People’s Hospital, Zhengzhou, China;Health Management Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hebei Province, Wuhan, China;Health Management Center, West China Hospital, Sichuan University, Sichuan Province, Chengdu, China;Health Management Center, Xiangya Hospital, Central South Hospital, Hunan Province, Changsha, China;Health Management Institute, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital, Beijing, China;

关键词: Chronic insomnia;    Nicotinamide mononucleotide (NMN);    Randomized controlled trial;   

DOI  :  10.1186/s13063-023-07351-8

 received in 2022-07-22, accepted in 2023-04-20,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe treatment of insomnia, which is the most common sleep disorder, includes drug and behavioral treatment, but each treatment measure has its limitations. So new treatment method needs to be taken to improve the treatment effect. MN supplementation is a potential promising new method for the treatment of insomnia, resulting in a rising need for methodological research towards verifying its efficacy.Methods/designWe describe a proposal for a multicenter, patient-assessor-blinded, randomized controlled trial with two parallel arms. A total of 400 chronic insomnia patients will be allocated 1:1 to the intervention group (treatment with oral NMN 320 mg/day) or control group (treatment with oral placebo). All subjects are clinical chronic insomnia patients who meet all inclusion criteria. All subjects are treated by taking NMN or placebo.The primary outcome is the score on the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes are the score on the Insomnia Severity Index (ISI) and Epworth Sleeping Scale (ESS), the total sleep time (TST), sleep efficiency (SE), sleep latency, and REM sleep latency to assess sleep quality changes.Subjects are assessed at two time points: baseline and follow-up. The duration of the clinical trial is 60 days.DiscussionThis study will provide more evidence on the effects of NMN on improving sleep quality among patients with chronic insomnia. If proven effective, NMN supplement can be used as a new treatment for chronic insomnia in the future.Trial registrationChinese Clinical Trial Registry (chictr.org.cn) ChiCTR2200058001. Registered on 26 March 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

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