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| Sponsored by: |
University of Bergen |
|---|---|
| Information provided by: | University of Bergen |
| ClinicalTrials.gov Identifier: | NCT00834886 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Delayed Sleep Phase Syndrome |
Dietary Supplement: Melatonin Other: Placebo melatonin Other: placebo light therapy Other: Light therapy |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Delayed Sleep Phase Syndrome in Adolescents. Sleep, Personality, Developmental History, Circadian Rhythm, Daytime Functioning and Treatment |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Melatonin and Light therapy: Experimental |
Dietary Supplement: Melatonin
Capsules, 3 mg, once every night
Other: Light therapy
Light therapy 10.000 lux by Miljølys AS
|
| Melatonin and placebo light: Experimental |
Dietary Supplement: Melatonin
Capsules, 3 mg, once every night
Other: placebo light therapy
Placebo light
|
| Placebo melatonin and light therapy: Experimental |
Other: Placebo melatonin
Capsule 3 mg, rice flour
Other: Light therapy
Light therapy 10.000 lux by Miljølys AS
|
|
Placebo melatonin and placebo light: Placebo Comparator
Placebo melatonin + placebo light therapy
|
Other: Placebo melatonin
Capsule 3 mg, rice flour
Other: placebo light therapy
Placebo light
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bjørn Bjorvatn, MD., PhD | +47 55586088 | bjorn.bjorvatn@isf.uib.no |
| Contact: Ane B. Wilhelmsen, Cand Psychol | +47 55586137 | ane.wilhelmsen@isf.uib.no |
| Norway | |
| University of Bergen | Recruiting |
| Bergen, Norway, 5020 | |
| Contact: Ane Wilhelmsen, Cand Psychol +47 55586137 sovgodt@hotmail.com | |
| Contact: Ingvild Saxvig, Cand Scient +47 55586064 ingvild.saxvig@isf.uib.no | |
| Principal Investigator: Bjørn Bjorvatn, MD, PhD | |
| Principal Investigator: | Bjørn Bjorvatn, MD., PhD | University of Bergen |
More Information
| Responsible Party: | University of Bergen ( Bjørn Bjorvatn, PhD, MD, Professor ) |
| Study ID Numbers: | NCT0006012009 |
| Study First Received: | January 9, 2009 |
| Last Updated: | February 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00834886 History of Changes |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway |
|
Antioxidants Sleep Disorders, Circadian Rhythm Mental Disorders Central Nervous System Depressants Disorders of Environmental Origin |
Dyssomnias Sleep Disorders Melatonin Occupational Diseases Chronobiology Disorders |
|
Antioxidants Sleep Disorders, Circadian Rhythm Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Dyssomnias Sleep Disorders Disorders of Environmental Origin Central Nervous System Depressants |
Chronobiology Disorders Protective Agents Pharmacologic Actions Pathologic Processes Mental Disorders Therapeutic Uses Syndrome Occupational Diseases Melatonin Central Nervous System Agents |
