NCT06971224 NADream: Effects of Nicotinamide Adenine Dinucleotide Supplementation on Sleep Quality in Healthy Individuals
| NCT ID | NCT06971224 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Haukeland University Hospital |
| Condition | Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 16 participants in total. It began in 2025-10-13 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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.
Contact & Investigator
Charalampos Tzoulis, PhD
STUDY DIRECTOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT06971224 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 60 Years, studying Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06971224 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06971224 currently recruiting?
Yes, NCT06971224 is actively recruiting participants. Contact the research team at charalampos.tzoulis@helse-bergen.no for enrollment information.
Where is the NCT06971224 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT06971224 clinical trial?
NCT06971224 is sponsored by Haukeland University Hospital. The principal investigator is Charalampos Tzoulis, PhD at Haukeland University Hospital. The trial plans to enroll 16 participants.