Randomized Controlled Trial on the Treatment Effects of Melatonin and Light Therapy on Delayed Sleep Phase Syndrome
Condition: Delayed Sleep Phase Syndrome
MeSH terms: Sleep Disorders, Circadian Rhythm; Syndrome
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Melatonin; Bright light; Placebo red light; Placebo capsule
Intervention type(s): Dietary Supplement; Other; Other; Other
Intervention description(s): 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
Other intervention name(s): Nature´s One melatonin, by Asman, Inc.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment