delayed sleep phase MedDRA version: 12.0 Level: LLT Classification code 10012209 Term: Delayed sleep phase
Conditions
Interventions
Trade Name: melatonin
Product Name: melatonin
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Gastroenteral use
Sponsors
Natural Pharma International Npi AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inability to fall asleep before midnight as a mean at least three times every school-week Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Somatic or mental disease producing sleep problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find if six days of melatonin administration in the afternoon is sufficient to advance the sleep phase significantly compared to placebo.;Secondary Objective: To find if 6+6 days of melatonin treatment is more effective than only 6 days.;Primary end point(s): Melatonin in saliva is measured before and after melatonin or placebo administration at 6 p.m. during 6 days. The probes are taken at exactly the same time late in the evening (when capsules are not taken) and early in the following morning. If the evening melatonin is significantly higher and the morning melatonin significantly lower after medication the sleep phase is advanced. | — |
Countries
Sweden
Outcome results
None listed