At a glance
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Delayed Sleep Phase Syndrome in Adolescents and Young Adults. Sleep, Personality, Developmental History, Circadian Rhythm, Daytime Functioning and Treatment
In Brief
A Phase 4 clinical trial evaluating Melatonin, Bright light, and 2 other interventions for Delayed Sleep Phase Syndrome. Completed, enrolled 40 participants across 1 site.
Detailed Summary
In this study the investigators will examine the effects of melatonin and light therapy on delayed sleep phase syndrome in adolescents 16 up to 20 years old. 60 subjects will be randomized into four different groups; melatonin + light therapy (N=15), melatonin + placebo light (N=15), placebo + light therapy (N=15) and placebo + placebo light. This is a double-blinded treatment and the participants will receive this treatment for 2 weeks. Then they will be re-randomized into two groups; full treatment with light therapy + melatonin (N=30) and no treatment (N=30) for 3 months unblinded. The investigators will test the subjects pre-treatment, post 2 week treatment and after 3 months.
Study Details
Timeline
Interventions
Capsules, 3 mg, once every night
Bright light therapy 10.000 lux by Miljølys AS
Red light 400 lux as placebo light
Capsules containing 3 mng rice flour, once every night