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: June 8, 2012
Last verified: June 2012
  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 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 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 treatment ends and 3 months after treatment ends ] [ Designated as safety issue: Yes ]

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
Experimental: Melatonin and Light therapy Dietary Supplement: Melatonin
Capsules, 3 mg, once every night
Other Name: Nature´s One melatonin, by Asman, Inc.
Other: Light therapy
Light therapy 10.000 lux by Miljølys AS
Experimental: Melatonin and placebo light Dietary Supplement: Melatonin
Capsules, 3 mg, once every night
Other Name: Nature´s One melatonin, by Asman, Inc.
Other: placebo light therapy
Placebo light
Other Name: Placebo light by Miljølys AS, 3-500 lux
Experimental: Placebo melatonin and light therapy Other: Placebo melatonin
Capsule 3 mg, rice flour
Other: Light therapy
Light therapy 10.000 lux by Miljølys AS
Placebo Comparator: Placebo melatonin and placebo light
Placebo melatonin + placebo light therapy
Other: Placebo melatonin
Capsule 3 mg, rice flour
Other: placebo light therapy
Placebo light
Other Name: Placebo light by Miljølys AS, 3-500 lux

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Last Updated: June 8, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on October 02, 2014