Table 2.

Registration data

Data category	Information
Primary registry and trial identifying number	ChiCTR2200058001
Date of registration in primary registry	March 26, 2022
Secondary identifying numbers	NA
Source(s) of monetary or material support	China Health Promotion Foundation
Primary sponsor	China Health Promotion Foundation
Secondary sponsor(s)	NA
Contact for public queries	Wu Shiyong (Email: 82,125,586@qq.com)
Contact for scientific queries	Qiang Zeng, MD (Email: zq301@126.com)
Public title	Oral nicotinamide mononucleotide (NMN) as a treatment for chronic insomnia: protocol for the multicenter, randomized, double-blind, placebo-controlled trial
Scientific title	Oral nicotinamide mononucleotide (NMN) as a treatment for chronic insomnia: protocol for the multicenter, randomized, double-blind, placebo-controlled trial
Countries of recruitment	China
Health condition(s) or problem(s) studied	Chronic insomnia
Intervention(s)	Active comparator: Nicotinamide mononucleotide (320 mg/day) Placebo comparator: Placebo
Key inclusion and exclusion criteria	Inclusion criteria: Age between 18 and 65 years; clinical diagnosis of chronic insomnia (according to the ICSD-3 criteria for chronic insomnia)
	Exclusion criteria: Physical diseases, mental disorders, and/or sleep disorders; received any insomnia drugs and psychotherapy within the preceding 1 month; on a continuous current daily intake of nutritional supplements and vitamin supplements
Study type	Interventional
	Multicenter, double-blinded, randomized controlled superiority trial with a two-group parallel design
	Phase III
Date of first enrolment	April 2022
Target sample size	400
Recruitment status	Recruiting
Primary outcome(s)	Pittsburgh Sleep Quality Index (PSQI)
Key secondary outcomes	Epworth Sleeping Scale (ESS), Insomnia Severity Index (ISI), Total sleep time (TST), sleep efficiency (SE), sleep latency, REM sleep latency, the percentage of N1, N2, N3, and REM