Healthy VolunteersNCT07284225
Effects of Single-Dose Nicotinamide Riboside (NR) on Sleep
A study testing Nicotinamide Riboside (NR) in people with Healthy Volunteers, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Nicotinamide Riboside (NR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Nicotinamide Riboside (NR), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
The placebo capsule is visually identical to the NR capsule but contains inert excipients without active pharmacological components.
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide Riboside (NR) Group | Experimental | Participants randomized to this arm will receive a single oral dose of 600 mg NR approximately one hour before their second overnight PSG assessment. Receives: Dietary Supplement: Nicotinamide Riboside (NR) |
| Placebo Group | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Night 1 and Night 2
Secondary outcomes (10)
Change in Total Sleep Time
Change in total sleep time from the baseline night to the intervention night, measured by overnight PSG, in minutes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 3 (morning after Night 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start17 Dec 2025
- Primary completion30 Aug 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284225
- Sponsor's protocol ID
- 2025287
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Single Dose of Nicotinamide Riboside (NR) on Sleep: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07284225
- Acronym / sponsor ID
- 2025287
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide Riboside (NR) Group | Experimental | Dietary Supplement: Nicotinamide Riboside (NR)Participants randomized to this arm will receive a single oral dose of 600 mg NR approximately one hour before their second overnight PSG assessment. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Nicotinamide Riboside (NR) Group |
| PlaceboThe placebo capsule is visually identical to the NR capsule but contains inert excipients without active pharmacological components. | Other | Placebo Group |
Primary outcome
Change in N3 Sleep Duration
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.
10 secondary outcomes
Change in Total Sleep Time
Time frame: Night 1 and Night 2
Change in Sleep Efficiency
Time frame: Night 1 and Night 2
Change in Sleep Onset Latency
Time frame: Night 1 and Night 2
Change in Wake After Sleep Onset
Time frame: Night 1 and Night 2
Change in Arousal Frequency
Time frame: Night 1 and Night 2
Change in N1 Sleep Duration
Time frame: Night 1 and Night 2
Change in N2 Sleep Duration
Time frame: Night 1 and Night 2
Change in REM Sleep Duration
Time frame: Night 1 and Night 2
Change in REM Sleep Onset Latency
Time frame: Night 1 and Night 2
Leeds Sleep Evaluation Questionnaire
Time frame: Day 3 (morning after Night 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide Riboside (NR) in people with Healthy Volunteers, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in N3 Sleep Duration (time frame: Night 1 and Night 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.