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Effects of Single-Dose Nicotinamide Riboside (NR) on Sleep

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoint(s) modified Show 11 more changesShow less
    • Lead sponsor: Eye & ENT Hospital of Fudan University to Eye & ENT Hospital of Fudan University
    • Completed without a posted recruiting period
    • Final enrollment: 28 participants (planned 20)
    • Primary completion date changed from estimate of Dec 30, 2026 to Aug 30, 2026
    • Study sites: 0 to 1
    • Study completion date changed from estimate of Dec 30, 2026 to Sep 1, 2026
    • Start date changed from estimate of Dec 20, 2025 to Dec 17, 2025
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 4 to 10
    • Study description expanded, about 46 words
    • Study title shortened, about 4 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07284225
Lead Sponsor Eye & ENT Hospital of Fudan University
Conditions
(from sponsor)
Healthy Volunteers
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov