SleepPhase 2NADreamNCT06971224
NADream: Effects of Nicotinamide Adenine Dinucleotide Supplementation on Sleep Quality in Healthy Individuals
A Phase 2 study testing Nicotinamide Riboside (NR) in people with Sleep, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to evalue the effects of nicotinamide adenine dinucleotide (NAD) supplementation (nicotinamide riboside (NR) form) on sleep in healthy adults compared to a placebo. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- 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
- 16 participants
- Where
- 1 siteNorway
- Study dates
- 13 Oct 2025to 1 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 40 to 60 years of age inclusive, at the time of signing the informed consent.
- Male or female.
- Participants who are healthy as determined by medical evaluation including medical history and physical examination.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the study protocol.
- Self-reported normal sleep patterns, assessed by Pittsburgh sleep quality index (PSQI; cutoff ≤ 5).
- No current use of sleep medications or supplements.
- Able to wear polysomnographic equipment and actigraphy during nighttime.
Who cannot join
- History of sleep disorders (e.g. insomnia, sleep apnea).
- Abnormal findings on PSG, such as sleep related breathing disorders (apnea-hypopnea index (AHI) ≥ 5), sleep related movement disorders (periodic limb movement index (PLMI) ≥ 15, and parasomnias (like REM sleep behavior disorder (RBD)).
- Chronic use of alcohol, tobacco, or medications affecting sleep.
- Significant psychiatric or medical conditions (including neurological, heart, lung, or sleep disorders/diseases).
- Travelled >1 time zone and night work <1 month before study, or during the study.
- Extreme chronotype according to the Composite Morningness Questionnaire (evening type; <22 and morning type >44).
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- Pregnancy.
- Breastfeeding.
- Supplements resulting in > 20 mg daily of nicotinamide riboside, nicotinamide mononucleotide (NMN), niacin (vitamin B3, nicotinic acid amide or other vitamin B3 analogues) less than 3 months prior to randomization.
- Participation in other clinical trials last 3 months.
- Deemed ineligible by lead principal investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen
Katarina Lundervold, MD, 55975045 ext. +47, neurosysmedstudier@helse-bergen.no
Katarina Lundervold, MD
About this study
Official title: NADream: Effects of Nicotinamide Adenine Dinucleotide Supplementation on Sleep Quality in Healthy Individuals: A Randomized Controlled Pilot Study
The purpose of this study is to evalue the effects of nicotinamide adenine dinucleotide (NAD) supplementation (nicotinamide riboside (NR) form) on sleep in healthy adults compared to a placebo. NAD is important for brain health and energy balance and a proposed explanation for its effect on sleep is that NAD supplementation restores the neurophysiological capacity of the brain to 'rest' during sleep. If this is the case, we expect the administration to result in improvements in sleep quality (and most likely sleep quantity) compared to placebo. Participants will receive either NAD supplementation or a placebo and their sleep will be measured to detect any differences between the two groups.
Read the detailed description
Nicotinamide adenine dinucleotide (NAD+) is important for regulating cellular energy metabolism, mitochondrial function, and circadian rhythms, which are key processes involved in the sleep-wake cycle and sleep regulation. Nicotinamide riboside (NR) supplementation has been shown to elevate NAD+ levels in humans. Higher NAD+ levels may support better sleep by restoration of mitochondrial efficiency and reducing oxidative stress.
As people age, there is evidence of a decline in NAD+ levels, which may lead to mitochondrial dysfunction, oxidative stress, and disruptions in circadian rhythms. These changes can negatively affect sleep architecture and reduce sleep quality. Impaired NAD+ metabolism has been linked to problems with the molecular clock, which regulates circadian timing through effects on sirtuin activity and clock genes such as BMAL1. NAD+ also supports brain metabolism by maintaining mitochondrial function, promoting neuroprotection, regulating redox balance, and reducing neuroinflammation. By restoring NAD+ levels, NR supplementation may help improve mitochondrial efficiency, decrease oxidative damage, and enhance sleep-related cellular maintenance. NR may also support synchronization of circadian rhythms, further promoting healthy sleep. Its effects also include modulating neuroinflammatory pathways and strengthening cellular resilience against oxidative stress, both of which are essential for maintaining cognitive functions and neural plasticity during sleep.
The NADream study will test whether NR supplementation can improve both objective and subjective measures of sleep in healthy adults. Sleep will be assessed using polysomnography (PSG), the gold standard for objective sleep measurement, along with actigraphy, Somnofy sleep monitoring, and the Pittsburgh Sleep Quality Index (PSQI). This study will be a randomized, placebo-controlled, double-blind, parallel-group design. Participants will be randomly assigned to receive ether NR or a placebo for 8 weeks. The findings from this study will help determine whether NR supplementation could be a viable therapeutic option to explore further in this area.
- Conditions
- Sleep
- Being tested
- Nicotinamide Riboside (NR), Placebo
- Keywords
- Sleep, Nicotinamide Riboside, NR, Nicotinamide adenine dinucleotide, NAD, Polysomonography, PSG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide Riboside (NR)Dietary supplement
Also called Nicotinamide adenine dinucleotide (NAD)
2000 mg NR daily.
PlaceboOther
Placebo tablet identical in taste, shape and appearance to NR tablets.
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide Riboside (NR) | Experimental | Nicotinamide Riboside (NR) administered in doses of 1000 mg twice daily for the duration of the trial (8 weeks). Receives: Dietary Supplement: Nicotinamide Riboside (NR) |
| Placebo | Other | Placebo, no active ingredients. Administered in tablet form twice daily for the duration of the trial (8 weeks). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the effect of NAD supplementation on objective sleep parameters via polysomnography (PSG).
The primary endpoint is the change in electrophysiological slow-wave activity (SWA; 0.5 - 4.0 Hz) per 60 minutes, measured by EEG, from baseline to week 8 between the 2000 mg NR and placebo groups.
Measured: From enrollment to the end of treatment at 8 weeks.
Secondary outcomes (10)
The secondary endpoints are to evaluate the effect of NAD supplementation on objective sleep parameters via polysomnography (PSG).
Slow wave energy (SWE) during sleep. Accumulated SWA as a putative homeostatic marker of sleep drive.
Measured: From enrollment to the end of treatment at 8 weeks.
EEG power
EEG power for each sleep stage in 1 Hz bins from 1 to 20 Hz.
Measured: From enrollment to the end of treatment at 8 weeks.
Arousals during sleep.
Arousals during sleep (abrupt cortical awakenings lasting >3 seconds).
Measured: From enrollment to the end of treatment at 8 weeks.
Theta activity.
Theta activity (5 - 8 Hz) during REM sleep, as a marker of REM sleep quality.
Measured: From enrollment to the end of treatment at 8 weeks.
Time in bed (TIB).
Time in bed (TIB, in minutes). Total time the person is laying down in bed.
Measured: From enrollment to the end of treatment at 8 weeks.
Sleep onset latency (SOL).
Sleep onset latency (SOL, in minutes). Length of time from full wakefulness to sleep.
Measured: From enrollment to the end of treatment at 8 weeks.
Total sleep time (TST).
Total sleep time (TST, in minutes). Total time the person sleeps.
Measured: From enrollment to the end of treatment at 8 weeks.
Sleep architecture.
Sleep architecture: time spent in non-rapid eye movement (NREM) stages and REM sleep, particularly the more restorative and deep sleep (stage N3/slow wave sleep) will be examined.
Measured: From enrollment to the end of treatment at 8 weeks.
Wake after sleep onset (WASO).
Wake after sleep onset (WASO, in minutes). Periods of wakefulness after defined sleep onset.
Measured: From enrollment to the end of treatment at 8 weeks.
Sleep efficiency (SE).
Sleep efficiency (SE) (time asleep/TIBx100)
Measured: From enrollment to the end of treatment at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start13 Oct 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blinded placebo-controlled study with a duration of 8 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Charalampos Tzoulis, PhD, Study director, Haukeland University HospitalKatarina Lundervold, MD, Principal investigator, University of BergenJanne Grønli, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971224
- Sponsor's protocol ID
- 2025/849242
- Other IDs
- 2025
- Acronym
- NADream
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang SQ, Lee J, Pan JP, Enger R, Hrubos-Strom H, Musiek ES, Fang EF, Le W. NAD+-circadian rhythm coupling in dementia. Alzheimers Dement. 2026 May;22(5):e71360. doi: 10.1002/alz.71360.
PubMed 42063312
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NADream: Effects of Nicotinamide Adenine Dinucleotide Supplementation on Sleep Quality in Healthy Individuals: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06971224
- Acronym / sponsor ID
- NADream / 2025/849242
- Conditions
- Sleep
- Keywords
- Sleep, Nicotinamide Riboside, NR, Nicotinamide adenine dinucleotide, NAD, Polysomonography, PSG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 13 Oct 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 14 May 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.
The purpose of this study is to evalue the effects of nicotinamide adenine dinucleotide (NAD) supplementation (nicotinamide riboside (NR) form) on sleep in healthy adults compared to a placebo. NAD is important for brain health and energy balance and a proposed explanation for its effect on sleep is that NAD supplementation restores the neurophysiological capacity of the brain to 'rest' during sleep. If this is the case, we expect the administration to result in improvements in sleep quality (and most likely sleep quantity) compared to placebo. Participants will receive either NAD supplementation or a placebo and their sleep will be measured to detect any differences between the two groups.
Detailed description
Nicotinamide adenine dinucleotide (NAD+) is important for regulating cellular energy metabolism, mitochondrial function, and circadian rhythms, which are key processes involved in the sleep-wake cycle and sleep regulation. Nicotinamide riboside (NR) supplementation has been shown to elevate NAD+ levels in humans. Higher NAD+ levels may support better sleep by restoration of mitochondrial efficiency and reducing oxidative stress.
As people age, there is evidence of a decline in NAD+ levels, which may lead to mitochondrial dysfunction, oxidative stress, and disruptions in circadian rhythms. These changes can negatively affect sleep architecture and reduce sleep quality. Impaired NAD+ metabolism has been linked to problems with the molecular clock, which regulates circadian timing through effects on sirtuin activity and clock genes such as BMAL1. NAD+ also supports brain metabolism by maintaining mitochondrial function, promoting neuroprotection, regulating redox balance, and reducing neuroinflammation. By restoring NAD+ levels, NR supplementation may help improve mitochondrial efficiency, decrease oxidative damage, and enhance sleep-related cellular maintenance. NR may also support synchronization of circadian rhythms, further promoting healthy sleep. Its effects also include modulating neuroinflammatory pathways and strengthening cellular resilience against oxidative stress, both of which are essential for maintaining cognitive functions and neural plasticity during sleep.
The NADream study will test whether NR supplementation can improve both objective and subjective measures of sleep in healthy adults. Sleep will be assessed using polysomnography (PSG), the gold standard for objective sleep measurement, along with actigraphy, Somnofy sleep monitoring, and the Pittsburgh Sleep Quality Index (PSQI). This study will be a randomized, placebo-controlled, double-blind, parallel-group design. Participants will be randomly assigned to receive ether NR or a placebo for 8 weeks. The findings from this study will help determine whether NR supplementation could be a viable therapeutic option to explore further in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized double-blinded placebo-controlled study with a duration of 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide Riboside (NR) | Experimental | Dietary Supplement: Nicotinamide Riboside (NR)Nicotinamide Riboside (NR) administered in doses of 1000 mg twice daily for the duration of the trial (8 weeks). |
| Placebo | Other | Other: PlaceboPlacebo, no active ingredients. Administered in tablet form twice daily for the duration of the trial (8 weeks). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant must be 40 to 60 years of age inclusive, at the time of signing the informed consent.
- Male or female.
- Participants who are healthy as determined by medical evaluation including medical history and physical examination.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the study protocol.
- Self-reported normal sleep patterns, assessed by Pittsburgh sleep quality index (PSQI; cutoff ≤ 5).
Key exclusion criteria (11 listed)
- History of sleep disorders (e.g. insomnia, sleep apnea).
- Abnormal findings on PSG, such as sleep related breathing disorders (apnea-hypopnea index (AHI) ≥ 5), sleep related movement disorders (periodic limb movement index (PLMI) ≥ 15, and parasomnias (like REM sleep behavior disorder (RBD)).
- Chronic use of alcohol, tobacco, or medications affecting sleep.
- Significant psychiatric or medical conditions (including neurological, heart, lung, or sleep disorders/diseases).
- Travelled >1 time zone and night work <1 month before study, or during the study.
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)Also: Nicotinamide adenine dinucleotide (NAD)2000 mg NR daily. | Dietary supplement | Nicotinamide Riboside (NR) |
| PlaceboPlacebo tablet identical in taste, shape and appearance to NR tablets. | Other | Placebo |
Primary outcome
The primary objective is to evaluate the effect of NAD supplementation on objective sleep parameters via polysomnography (PSG).
Time frame: From enrollment to the end of treatment at 8 weeks.
The primary endpoint is the change in electrophysiological slow-wave activity (SWA; 0.5 - 4.0 Hz) per 60 minutes, measured by EEG, from baseline to week 8 between the 2000 mg NR and placebo groups.
10 secondary outcomes
The secondary endpoints are to evaluate the effect of NAD supplementation on objective sleep parameters via polysomnography (PSG).
Time frame: From enrollment to the end of treatment at 8 weeks.
EEG power
Time frame: From enrollment to the end of treatment at 8 weeks.
Arousals during sleep.
Time frame: From enrollment to the end of treatment at 8 weeks.
Theta activity.
Time frame: From enrollment to the end of treatment at 8 weeks.
Time in bed (TIB).
Time frame: From enrollment to the end of treatment at 8 weeks.
Sleep onset latency (SOL).
Time frame: From enrollment to the end of treatment at 8 weeks.
Total sleep time (TST).
Time frame: From enrollment to the end of treatment at 8 weeks.
Sleep architecture.
Time frame: From enrollment to the end of treatment at 8 weeks.
Wake after sleep onset (WASO).
Time frame: From enrollment to the end of treatment at 8 weeks.
Sleep efficiency (SE).
Time frame: From enrollment to the end of treatment at 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 42063312Zhang SQ, Lee J, Pan JP, Enger R, Hrubos-Strom H, Musiek ES, Fang EF, Le W. NAD+-circadian rhythm coupling in dementia. Alzheimers Dement. 2026 May;22(5):e71360. doi: 10.1002/alz.71360.
- Individual participant dataSharing planned: No
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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.
Charalampos Tzoulis, PhD study director
Haukeland University Hospital
Katarina Lundervold, MD principal investigator
University of Bergen
Janne Grønli, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide Riboside (NR) in people with Sleep, run by Haukeland University Hospital at 1 site in Norway.
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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charalampos Tzoulis, PhD (55975061 ext. 47, charalampos.tzoulis@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to evaluate the effect of NAD supplementation on objective sleep parameters via polysomnography (PSG). (time frame: From enrollment to the end of treatment at 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06971224, which also lists 1 linked publication.
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 15 Sep 2025.