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 |