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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bjorn Bjorvatn, University of Bergen
ClinicalTrials.gov Identifier:
NCT00834886
First received: January 9, 2009
Last updated: January 13, 2015
Last verified: January 2015
  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: Bright light
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Delayed Sleep Phase Syndrome in Adolescents and Young Adults. Sleep, Personality, Developmental History, Circadian Rhythm, Daytime Functioning and Treatment

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    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").

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Combination
Bright light 10.000 lux + melatonin 3 mg
Dietary Supplement: Melatonin
Capsules, 3 mg, once every night
Other Name: Nature´s One melatonin, by Asman, Inc.
Other: Bright light
Bright light therapy 10.000 lux by Miljølys AS
Active Comparator: Melatonin
Melatonin 3 mg + placebo red light 400 lux
Dietary Supplement: Melatonin
Capsules, 3 mg, once every night
Other Name: Nature´s One melatonin, by Asman, Inc.
Active Comparator: Bright light
Bright light 10.000 lux + placebo capsule 3 mg rice flour
Other: Bright light
Bright light therapy 10.000 lux by Miljølys AS
Placebo Comparator: Placebo
Placebo red light 400 lux + placebo capsule 3 mg rice flour

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.

  Eligibility

Ages Eligible for Study:   16 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00834886

Locations
Norway
University of Bergen
Bergen, Norway, 5020
Sponsors and Collaborators
University of Bergen
Investigators
Principal Investigator: Bjørn Bjorvatn, MD., PhD University of Bergen
  More Information

Publications:
Responsible Party: Bjorn Bjorvatn, Professor, MD, PhD, University of Bergen
ClinicalTrials.gov Identifier: NCT00834886     History of Changes
Other Study ID Numbers: NCT0006012009
Study First Received: January 9, 2009
Results First Received: August 1, 2014
Last Updated: January 13, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Syndrome
Chronobiology Disorders
Disease
Dyssomnias
Mental Disorders
Nervous System Diseases
Occupational Diseases
Pathologic Processes
Sleep Disorders
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 03, 2015