drugset / Trial / NCT03514732
Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Primary Objective: To estimate the range of improvement of NOVANUIT® triple action on sleep quality global score. Secondary Objectives: * To estimate the range of improvement of NOVANUIT® triple action on following parameters: time for getting asleep, sleep time, number of nocturnal awakening, number of nightmares, sleep quality (score from 0 to 10), and mean tiredness during the day (score from 0 to 10). * To estimate persistency of NOVANUIT® triple action effects after end of study product consumption. * To assess dependency to NOVANUIT® triple action after study product cessation. * To assess tolerance of NOVANUIT® triple action during the study.
Timeline
- Start
- 2017-03-17
- Primary completion
- 2017-07-05
- Completion
- 2017-07-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 2 unknown | Oral |