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

Efficacy of a Single Dose of Nicotinamide Riboside (NR) on Sleep: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Nicotinamide Riboside (NR); Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200031
      • Eye & ENT Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• History of chronic smoking, heavy alcohol consumption (exceeding weekly recommended intake), or substance abuse;
• Participation in any other interventional clinical studies within one month prior to study initiation, or exposure to circadian rhythm-disrupting factors such as trans-time zone travel or frequent night shifts;
• Pregnant women, breastfeeding women, or men of reproductive age with plans to conceive within the next month who are not using effective contraception.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nicotinamide Riboside (NR) Group; Participants randomized to this arm will receive a single oral dose of 600 mg NR approximately one hour before their second overnight PSG assessment.	Dietary supplement: Nicotinamide Riboside (NR); 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 Comparator: Placebo Group; Participants randomized to this arm will receive a matching placebo capsule approximately one hour before their second overnight PSG assessment. The placebo is identical in appearance to the NR capsule and contains inert ingredients without active pharmacological effects.	Other: Placebo; The placebo capsule is visually identical to the NR capsule but contains inert excipients without active pharmacological components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in N3 Sleep Duration	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.	Night 1 and Night 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Sleep Time	Change in total sleep time from the baseline night to the intervention night, measured by overnight PSG, in minutes.	Night 1 and Night 2
Change in Sleep Efficiency	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.	Night 1 and Night 2
Change in Sleep Onset Latency	Change in sleep onset latency from the baseline night to the intervention night, measured by overnight PSG, in minutes.	Night 1 and Night 2
Change in Wake After Sleep Onset	Change in wake after sleep onset from the baseline night to the intervention night, measured by overnight PSG, in minutes.	Night 1 and Night 2
Change in Arousal Frequency	Change in arousal frequency during overnight sleep from the baseline night to the intervention night, measured by overnight PSG.	Night 1 and Night 2
Change in N1 Sleep Duration	Change in N1 sleep duration from the baseline night to the intervention night, measured by overnight PSG, in minutes.	Night 1 and Night 2
Change in N2 Sleep Duration	Change in N2 sleep duration from the baseline night to the intervention night, measured by overnight PSG, in minutes.	Night 1 and Night 2
Change in REM Sleep Duration	Change in REM sleep duration from the baseline night to the intervention night, measured by overnight PSG, in minutes.	Night 1 and Night 2
Change in REM Sleep Onset Latency	Change in REM sleep onset latency from the baseline night to the intervention night, measured by overnight PSG, in minutes.	Night 1 and Night 2
Leeds Sleep Evaluation Questionnaire	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.	Day 3 (morning after Night 2)

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Actual): August 30, 2026
• Study Completion (Actual): September 1, 2026

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 12, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: nicotinamide-beta-riboside
• Other Study ID Numbers: 2025287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No