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

Phase 4

Completed

Conditions: Delayed Sleep Phase Syndrome

Interventions: Dietary Supplement: Melatonin
Other: Bright light
Other: Placebo red light
Other: Placebo capsule

Registration Number: NCT00834886

Lead Sponsor: University of Bergen

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination	Melatonin	Bright light 10.000 lux + melatonin 3 mg
Bright light	Bright light	Bright light 10.000 lux + placebo capsule 3 mg rice flour
Melatonin	Melatonin	Melatonin 3 mg + placebo red light 400 lux
Combination	Bright light	Bright light 10.000 lux + melatonin 3 mg
Placebo	Placebo red light	Placebo Red light 400 lux + placebo capsule 3 mg rice flour
Melatonin	Placebo red light	Melatonin 3 mg + placebo red light 400 lux
Placebo	Placebo capsule	Placebo Red light 400 lux + placebo capsule 3 mg rice flour
Bright light	Placebo capsule	Bright light 10.000 lux + placebo capsule 3 mg rice flour

Primary Outcome Measures

Name	Time	Method
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.	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.
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.	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").
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.	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.