Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031, China
NCT Number: NCT07284225
This study aims to evaluate whether a single oral dose of nicotinamide riboside (NR), a precursor of nicotinamide adenine dinucleotide (NAD+), has acute effects on sleep in healthy adults who report mild sleep difficulties. NR is widely used as a nutritional supplement and is known to increase cellular NAD+ levels, which may influence physiological processes linked to sleep-wake regulation.
In this randomized, double-blind, placebo-controlled study, 28 healthy adults will complete two overnight sleep assessments using polysomnography (PSG), the gold-standard sleep monitoring method. After a baseline night of sleep recording, participants will receive either NR or a placebo before bedtime on the second night. The primary outcome is the change in N3 sleep duration from the baseline night to the intervention night. Subjective sleep quality assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ), together with other objective sleep measures derived from PSG, will be evaluated as secondary outcomes.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200031, China
Sleep quality is a major component of overall health, yet many adults experience mild but persistent sleep difficulties. Nicotinamide riboside (NR) is a naturally occurring precursor of NAD+, a key coenzyme involved in cellular energy metabolism and circadian regulation. Preclinical studies suggest that NR may influence neural pathways related to sleep-wake control, but its short-term effects on human sleep have not been well established.
This study is designed to explore the acute impact of NR on sleep in healthy adults with mild subjective sleep complaints. It uses a randomized, double-blind, placebo-controlled design to minimize bias. All participants will spend two consecutive nights in a controlled sleep laboratory. The first night serves as a baseline assessment of natural sleep. On the second night, individuals will receive a single 600 mg dose of NR or a matched placebo one hour before bedtime.
Polysomnography (PSG) will be used to evaluate objective sleep parameters, with the prespecified primary outcome being the change in N3 (slow-wave) sleep duration from the baseline night to the intervention night. Secondary PSG outcomes include changes in total sleep time, sleep efficiency, sleep onset latency, wake after sleep onset, arousal frequency, N1, N2 and REM sleep durations, and REM sleep onset latency. Subjective sleep quality is assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ) on the morning after the intervention night. Safety will be monitored throughout the study period and through a follow-up contact after discharge. This exploratory early-phase study aims to generate human data on the feasibility, safety, and acute effects of NR on both subjective and objective sleep-related measures.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single oral dose of 600 mg NR, an NAD+ precursor compound, provided in capsule form. The dose and timing are standardized for all participants.
The placebo capsule is visually identical to the NR capsule but contains inert excipients without active pharmacological components.
Time frame: Night 1 and Night 2
Change in the duration of N3 (slow-wave) sleep from the baseline night to the intervention night, measured by overnight PSG. The change is calculated as the N3 sleep duration on the intervention night minus the N3 sleep duration on the baseline night, in minutes.
Time frame: Night 1 and Night 2
Change in total sleep time from the baseline night to the intervention night, measured by overnight PSG, in minutes.
Time frame: Night 1 and Night 2
Change in sleep efficiency from the baseline night to the intervention night, measured by overnight PSG. The change in sleep efficiency is expressed in percentage points.
Time frame: Night 1 and Night 2
Change in sleep onset latency from the baseline night to the intervention night, measured by overnight PSG, in minutes.
Time frame: Night 1 and Night 2
Change in wake after sleep onset from the baseline night to the intervention night, measured by overnight PSG, in minutes.
Time frame: Night 1 and Night 2
Change in arousal frequency during overnight sleep from the baseline night to the intervention night, measured by overnight PSG.
Time frame: Night 1 and Night 2
Change in N1 sleep duration from the baseline night to the intervention night, measured by overnight PSG, in minutes.
Time frame: Night 1 and Night 2
Change in N2 sleep duration from the baseline night to the intervention night, measured by overnight PSG, in minutes.
Time frame: Night 1 and Night 2
Change in REM sleep duration from the baseline night to the intervention night, measured by overnight PSG, in minutes.
Time frame: Night 1 and Night 2
Change in REM sleep onset latency from the baseline night to the intervention night, measured by overnight PSG, in minutes.
Time frame: Day 3 (morning after Night 2)
Subjective sleep quality assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ) on the morning after the intervention night. The LSEQ is a validated 10-item questionnaire with four domain scores: getting to sleep (GTS), quality of sleep (QOS), awakening from sleep (AFS), and behavior following wakefulness (BFW), together with a total score. Each item is rated on an 11-point scale from 0 to 10, with higher scores indicating greater perceived improvement relative to habitual sleep.
Eye & ENT Hospital of Fudan University
Other
Efficacy of a Single Dose of Nicotinamide Riboside (NR) on Sleep: A Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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