Disease: Healthy individuals
Type of study: Interventional trial
Coordinating investigator: Katarina Lundervold
Study director: Charalampos Tzoulis
Background: Sleep physiology is strongly associated with pathological brain aging and neurodegenerative disorders, including Parkinson's disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and Alzheimer’s disease. Our earlier trials in PD, have provided post-hoc signals indicating that NAD-augmentation therapy with oral NR may have beneficial effects on human sleep physiology. This is also supported by studies in rodents. However, the effects of NAD-augmentation therapy on human sleep physiology have not been formally studied.
NADream is a randomised, double-blind, placebocontrolled, Phase I study, which will explore the effects of NAD-augmentation therapy on human sleep. A total of 20 healthy volunteers will be recruited and randomized on NR 2000 mg per day or placebo for 4 weeks. In addition, a subset of participants will undergo two cycles of sleep deprivation at baseline and the end of the trial. Measurements will include polysomnography to quantitatively assess relevant electrophysiological properties of the brain, such as sleep pressure, as well as a multitude of clinical and biochemical assessments. Based on the results of the NADream trial, we will design and implement appropriate measures of treatment effects on sleep in our NAD-trials in neurodegenerative and neuroinflammatory diseases. Moreover, we will identify whether oral NR treatment has potential to improve sleep quality in health and disease.
Objectives: The trial is exploratory. The main objective is to assess the effects of NR on the quality of sleep (polysomnography- and questionnaire-based endpoints) and on the recovery rate from sleep deprivation (i.e., quantification of sleep pressure and clinical rating).
Status: The study is funded, and protocol has been established during 2024-2025. Recruitment started in Q2 2025 and 5 participants have been randomized so far.
Participating centres
- Haukeland University Hospital, Bergen
Funding
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- The University of Bergen
More information
For more information or to join the study, please contact: neurosysmedstudier@helse-bergen.no