Acute Effects of Nicotinamide Riboside on Polysomnography-Measured Sleep Structure in Healthy Adults

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEye & ENT Hospital of Fudan University

About this trial

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, 20 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. Researchers will compare sleep duration and sleep structure before and after the intervention to determine whether NR has an acute effect on objective sleep quality.

The study will also evaluate safety and collect participants' subjective sleep impressions. Findings may help clarify whether NR, a widely used nutritional supplement, has measurable short-term effects on human sleep.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy males or females aged 18 to 60 years inclusive;

Screening using the Pittsburgh Sleep Quality Index (PSQI) scale with a total score between 5 and 10, indicating mild subjective sleep disturbance;

Voluntarily participate in this study and sign a written informed consent form;

Able to understand the study procedures and willing to comply with all laboratory regulations.

Disqualifiers

History of any serious neurological, cardiovascular, respiratory, hepatic, renal, hematological, or psychiatric disorders;

Medically diagnosed sleep disorders (e.g., insomnia, sleep apnea syndrome, restless legs syndrome);

Regular use within the past month of any medication or supplement that may affect sleep (e.g., sedatives, antidepressants, antihistamines, melatonin);

Known allergy to nicotinamide riboside (NR) or any component of the study product;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nicotinamide Riboside (NR)

    Dietary supplement

    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.

  • Placebo

    Other intervention

    The placebo capsule is visually identical to the NR capsule but contains inert excipients without active pharmacological components.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Nicotinamide Riboside (NR) GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Sleep Time (TST)

Total amount of sleep obtained during the overnight PSG recording, measured in minutes.

Time frame
Measured during the baseline night (pre-intervention) and the experimental night (post-NR or placebo).

Secondary outcomes

1

Sleep Latency

Duration from lights-off to the first epoch of any sleep stage during PSG, measured in minutes.

Time frame
Measured during the baseline night (pre-intervention) and the experimental night (post-NR or placebo).
2

Wake After Sleep Onset

Total duration of wakefulness after initial sleep onset but before final awakening, measured in minutes via PSG.

Time frame
Measured during the baseline night (pre-intervention) and the experimental night (post-NR or placebo).
3

Sleep Stage Distribution

Minutes spent in N1, N2, N3, and REM sleep during overnight PSG, recorded as absolute minutes for each stage.

Time frame
Measured during the baseline night (pre-intervention) and the experimental night (post-NR or placebo)
4

Leeds Sleep Evaluation Questionnaire

Self-reported subjective sleep quality assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ). The outcome is reported as a total score ranging from 0 to 10, with higher scores indicating better perceived sleep quality and better condition upon awakening.

Time frame
Morning of the day after the experimental night (approximately 8:00 AM).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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