Acute Effects of Nicotinamide Riboside on Polysomnography-Measured Sleep Structure in Healthy Adults
NCT ID: NCT07284225
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-12-20
2026-12-30
Brief Summary
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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.
Detailed Description
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This study is designed to explore the acute impact of NR on objectively measured 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 total sleep time, sleep stages, sleep efficiency, sleep latency, and wakefulness during the night. Subjective sleep quality will be assessed with validated questionnaires administered the morning after each sleep recording. Safety will be monitored throughout the study period and through a follow-up contact after discharge.This exploratory early-phase study aims to generate objective human data regarding the feasibility, safety, and potential sleep-modulating effects of NR.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
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 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.
Placebo
The placebo capsule is visually identical to the NR capsule but contains inert excipients without active pharmacological components.
Interventions
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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
The placebo capsule is visually identical to the NR capsule but contains inert excipients without active pharmacological components.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2025287
Identifier Type: -
Identifier Source: org_study_id