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NCT Number: NCT00834886

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

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.

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Key information

Conditions

Delayed Sleep Phase Syndrome Chronobiology Disorders Dyssomnias Mental Disorders Nervous System Diseases Occupational Diseases Sleep Disorders, Circadian Rhythm Sleep Wake Disorders

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Bergen

Bergen, 5020, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

melatonin

Dietary Supplement

Capsules, 3 mg, once every night

Other names: Nature´s One melatonin, by Asman, Inc.

bright light

Other

Bright light therapy 10.000 lux by Miljølys AS

Placebo red light

Other

Red light 400 lux as placebo light

Placebo capsule

Other

Capsules containing 3 mng rice flour, once every night

Primary outcomes

  1. To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.

    Time frame: 1 day after two-week treatment ends

    Sleep diary, rise time (when participants rise from bed in the morning, self-report) before and after a randomized controlled 4 armed treatment study including a follow-up 3 months later.

    Midnight is 0000; in the outcome measure table the value is given in minutes after midnight.

    i.e. 530 equals 08:50 in the morning.

  2. To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.

    Time frame: 1 day after 2-week treatment ended

    Subjective sleepiness; Karolinska sleepiness scale (KSS). The KSS is a scale in which the subjects rate their concurrent sleepiness level. The scale is verbally anchored with steps ranging from 1 ("very alert") to 9 ("very sleepy, fighting sleep, effort to stay awake").

  3. To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.

    Time frame: 1 day after 2-week treatment ended

    Actigraphy, sleep onset latency (SOL). An actigraph is a wrist-worn movement sensor that objectively record motor activity. Participants used an event button to mark bed time and rise time. The actiwatch is waterproof and participants were instructed not to take it off at any time during the data collection peroid.

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

Delayed Sleep Phase Syndrome in Adolescents and Young Adults. Sleep, Personality, Developmental History, Circadian Rhythm, Daytime Functioning and Treatment

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 3, 2009
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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