Delayed Sleep Phase Syndrome Clinical Trial
Official title:
Delayed Sleep Phase Syndrome in Adolescents and Young Adults. Sleep, Personality, Developmental History, Circadian Rhythm, Daytime Functioning and Treatment
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.
Delayed sleep phase syndrome (DSPS) is a circadian rhythm sleep disorder where the
sleep-wake rhythm is significantly delayed according to the environmental demands. Hence,
the symptoms consist of major difficulties falling asleep and problems awakening in due time
and patients often experience work- and school related impairments (The International
Classification of Sleep Disorders: Diagnostic and Coding manual, 2005). However, correct
diagnosis is often not made and the treatment offered is, accordingly, often inadequate.
DSPS normally develops in interplay between dysfunctional habits/behaviour and biological
vulnerability.
Bright light therapy and administration of exogenous melatonin comprise the most common
interventions. Timed bright light has been shown to effectively phase advance the rhythm
(Rosenthal et al., 1990), but no standardized guidelines regarding the duration, intensity
or timing of light exposure have been established. Compliance to the treatment is often poor
because it involves structuring the daily schedule, which may be hard for the relevant age
group. Similarly, administration of melatonin in the evening has been shown to phase advance
the rhythm (Lewy et al., 1998; Mundey, Benloucif, Harsanyi, Dubocovich, & Zee, 2005), but a
standardized approach for dose, duration and timing is lacking.
It is important to establish effective treatment guidelines for delayed sleep phase
syndrome. Large scale studies on the effects of melatonin and bright light treatment in
randomized placebo-controlled designs are needed. In a clinical trial we aim to investigate
the efficacy of bright light and melatonin treatment using a 4 armed randomized placebo
controlled design.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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