insomnia Poor quality of sleep
Conditions
Interventions
The study will take approximately 3-6 weeks per subject, during which the
selected dosage forms and a placebo is tested in triplicate, which adds up to 9
test nights. Test nights are separated by at
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (1) Age 18 - 75, (2) Non-smoking, (3) Healthy, (4) Light disturbed sleep for at least six months, on a regular basis
Exclusion criteria
Exclusion criteria: 1) Severe sleep disorders (sleep apnoea, restless legs syndrome), (2) no apparent cause for the sleep disorders (3) Clinically significant abnormal liver functioning, (4) Clinically significant abnormal serum creatinin, (5) BMI lower than 18 or higher than 30, (6) Use of concomitant medications or supplements, (7) Blood donation during the last 4 weeks prior to the first dosing. It is advised not to donate blood till 4 weeks after the last dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the study is the determination of the sleep quality, as assessed objectively with an unobtrusive portable sleep monitoring system, based on EEG/EMG coupled with an automatic sleep phase classifier. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints consist of subjective sleep quality ratings and fitness/tiredness/cognitive ratings, obtained through questionnaires. | — |
Countries
Netherlands
Outcome results
None listed