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Randomized Controlled Trial on the Treatment Effects of Melatonin and Light Therapy on Delayed Sleep Phase Syndrome

NCT00834886 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-03-14

Study results available
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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.

Conditions

  • Delayed Sleep Phase Syndrome

Interventions

DIETARY_SUPPLEMENT

Melatonin

Capsules, 3 mg, once every night

OTHER

Bright light

Bright light therapy 10.000 lux by Miljølys AS

OTHER

Placebo red light

Red light 400 lux as placebo light

OTHER

Placebo capsule

Capsules containing 3 mng rice flour, once every night

Sponsors & Collaborators

  • University of Bergen

    lead OTHER

Principal Investigators

  • Bjørn Bjorvatn, MD., PhD · University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00834886 on ClinicalTrials.gov