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

NCT ID: NCT00834886

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-01-31

Brief 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.

Conditions

Delayed Sleep Phase Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Combination

Bright light 10.000 lux + melatonin 3 mg

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Capsules, 3 mg, once every night

Bright light

Intervention Type: OTHER

Bright light therapy 10.000 lux by Miljølys AS

Melatonin

Melatonin 3 mg + placebo red light 400 lux

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Capsules, 3 mg, once every night

Placebo red light

Intervention Type: OTHER

Red light 400 lux as placebo light

Bright light

Bright light 10.000 lux + placebo capsule 3 mg rice flour

Group Type: ACTIVE_COMPARATOR

Bright light

Intervention Type: OTHER

Bright light therapy 10.000 lux by Miljølys AS

Placebo capsule

Intervention Type: OTHER

Capsules containing 3 mng rice flour, once every night

Placebo

Placebo Red light 400 lux + placebo capsule 3 mg rice flour

Group Type: PLACEBO_COMPARATOR

Placebo red light

Intervention Type: OTHER

Red light 400 lux as placebo light

Placebo capsule

Intervention Type: OTHER

Capsules containing 3 mng rice flour, once every night

Interventions

Melatonin

Capsules, 3 mg, once every night

Intervention Type: DIETARY_SUPPLEMENT

Bright light

Bright light therapy 10.000 lux by Miljølys AS

Intervention Type: OTHER

Placebo red light

Red light 400 lux as placebo light

Intervention Type: OTHER

Placebo capsule

Capsules containing 3 mng rice flour, once every night

Intervention Type: OTHER

Other Intervention Names

Nature´s One melatonin, by Asman, Inc.

Eligibility Criteria

Inclusion Criteria

• 16-25 years old
• lives in the Bergen area
• has Delayed Sleep Phase Disorder

Exclusion Criteria

• pregnant or nursing women
• other sleep disorders (i.e. sleep apnoea or PLMS)
• moderate to serious psychiatric disease
• use of psychopharmacological medicines
• in psychotherapeutic treatment

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Bjorn Bjorvatn

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bjørn Bjorvatn, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

University of Bergen

Bergen, Bergen, Norway

Countries

Norway

References

Wilhelmsen-Langeland A, Saxvig IW, Pallesen S, Nordhus IH, Vedaa O, Lundervold AJ, Bjorvatn B. A randomized controlled trial with bright light and melatonin for the treatment of delayed sleep phase disorder: effects on subjective and objective sleepiness and cognitive function. J Biol Rhythms. 2013 Oct;28(5):306-21. doi: 10.1177/0748730413500126.

Reference Type: RESULT

PMID: 24132057 (View on PubMed)

Saxvig IW, Wilhelmsen-Langeland A, Pallesen S, Vedaa O, Nordhus IH, Bjorvatn B. A randomized controlled trial with bright light and melatonin for delayed sleep phase disorder: effects on subjective and objective sleep. Chronobiol Int. 2014 Feb;31(1):72-86. doi: 10.3109/07420528.2013.823200. Epub 2013 Oct 21.

Reference Type: RESULT

PMID: 24144243 (View on PubMed)

Other Identifiers

00834886

Identifier Type: -

Identifier Source: org_study_id