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

NCT00834886 | Completed Phase 4 Results DMC

• 1 other identifier: 00834886
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Delayed Sleep Phase Syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  1 day after two-week treatment ends

• 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.

  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").

  1 day after 2-week treatment ended

• 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.

  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.

  1 day after 2-week treatment ended

Study Arms (4)

Combination

ACTIVE COMPARATOR

Bright light 10.000 lux + melatonin 3 mg

Dietary Supplement: Melatonin; Other: Bright light

Melatonin

ACTIVE COMPARATOR

Melatonin 3 mg + placebo red light 400 lux

Dietary Supplement: Melatonin; Other: Placebo red light

Bright light

ACTIVE COMPARATOR

Bright light 10.000 lux + placebo capsule 3 mg rice flour

Other: Bright light; Other: Placebo capsule

Placebo

PLACEBO COMPARATOR

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

Other: Placebo red light; Other: Placebo capsule

Interventions

Melatonin DIETARY_SUPPLEMENT

Capsules, 3 mg, once every night

Also known as: Nature´s One melatonin, by Asman, Inc.

Combination; Melatonin

Bright light OTHER

Bright light therapy 10.000 lux by Miljølys AS

Bright light; Combination

Placebo red light OTHER

Red light 400 lux as placebo light

Melatonin; Placebo

Placebo capsule OTHER

Capsules containing 3 mng rice flour, once every night

Bright light; Placebo

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

University of Bergen

Bergen, Bergen, 5020, Norway

Location

Related Publications (2)

• 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.

  PMID: 24132057 RESULT

• 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.

  PMID: 24144243 RESULT

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Bjørn Bjorvatn
• Organization: University of Bergen

bjorn.bjorvatn@igs.uib.no

55586130

Study Officials

• Bjørn Bjorvatn, MD., PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: February 3, 2009
• Study Start: October 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 14, 2016
• Results First Posted: December 8, 2014

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)