Delayed Sleep Phase Syndrome in Adolescents and Young Adults. Sleep, Personality, Developmental History, Circadian Rhythm, Daytime Functioning and Treatment
Sponsor study identifier
interventional
40
1 country
1
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2012
Actual (reported)Study Completion
January 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 9, 2009
Actual (reported)February 3, 2009
Actual (reported)January 2012
Actual (reported)January 2012
Actual (reported)December 8, 2014
Actual (reported)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
Bright light 10.000 lux + melatonin 3 mg
Melatonin 3 mg + placebo red light 400 lux
Bright light 10.000 lux + placebo capsule 3 mg rice flour
Capsules, 3 mg, once every night
Bright light therapy 10.000 lux by Miljølys AS
University of Bergen
Bergen, Bergen, 5020, Norway
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.
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.
Bjørn Bjorvatn, MD., PhD
University of Bergen
40 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2009
First Posted
February 3, 2009
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
Placebo Red light 400 lux + placebo capsule 3 mg rice flour
Red light 400 lux as placebo light
Capsules containing 3 mng rice flour, once every night
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Primary Completion
January 2012
Actual (reported)Study Completion
January 2012
Actual (reported)Last Updated
March 14, 2016
Results First Posted
December 8, 2014
Record last verified: 2016-03
Publications from the stury are reported here. IPD can be retrieved upon request to the study investigator.
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