Title: Potential New Treatment for Chronic Insomnia: Study Investigates the Effects of Nicotinamide Mononucleotide (NMN)
Introduction: Insomnia is a common sleep disorder that affects a significant portion of the population. While current treatments exist, there is a need for more effective methods to address the challenges associated with insomnia. A potential new treatment, nicotinamide mononucleotide (NMN) supplementation, is being explored. This article summarizes a randomized controlled trial that aims to evaluate the effects of NMN supplementation on chronic insomnia patients.
Study Design and Objective:
The trial, registered with the Chinese Clinical Trial Registry, will include 400 chronic insomnia patients recruited from nine hospitals in China. Participants will be randomly allocated to either the intervention group (receiving oral NMN) or the control group (receiving oral placebo). The primary outcome measure is the score on the Pittsburgh Sleep Quality Index (PSQI), with secondary outcomes including scores on the Insomnia Severity Index (ISI) and Epworth Sleeping Scale (ESS), as well as various sleep quality parameters. The trial duration is 60 days, with assessments conducted at baseline and follow-up.
Significance and Potential Impact:
Insomnia has a profound impact on morbidity, productivity, and quality of life. The current treatment options have limitations, leading to the exploration of alternative methods. NMN supplementation has shown promise in improving sleep quality through its effect on NAD+ levels and metabolic processes. If successful, NMN could become a new treatment option for chronic insomnia, addressing unmet medical needs and improving patient outcomes.
Trial Details and Funding:
The trial, funded by the China Health Promotion Foundation, is a multicenter, randomized, double-blind, placebo-controlled study. It is in the Phase III stage and is anticipated to begin enrollment in April 2022. The trial protocol and recruitment target sample size of 400 participants have been established. The study is solely funded by non-commercial sources, ensuring independent research.
Trial Methodology and Data Analysis:
The trial follows rigorous methodology, including randomization, double-blinding, and placebo control. Outcome assessors and data analysts will be blinded to ensure unbiased results. Data collection and analysis will utilize standardized measures and statistical software. The intention-to-treat analysis principle will be followed, ensuring robust findings. Dissemination plans include scientific publications and sharing results with the public and patient organizations.
This trial investigates the potential of oral NMN supplementation as a new treatment for chronic insomnia. It aims to provide evidence on the efficacy and safety of NMN and addresses the limitations of current treatment options. If confirmed, this study could offer hope to chronic insomnia patients and improve their overall well-being.
Title of paper: Oral nicotinamide mononucleotide (NMN) to treat chronic insomnia: protocol for the multicenter, randomized, double-blinded, placebo-controlled trial
Author(s): Gao X, Li J, Xu S, Li X, Wang X, Li Y, Huang Y, Liu S, Zeng Q.
Year published: 2023
Published in: Trials
Original article can be found here.