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临床试验/NCT00834886
NCT00834886已完成4 期

Delayed Sleep Phase Syndrome in Adolescents and Young Adults. Sleep, Personality, Developmental History, Circadian Rhythm, Daytime Functioning and Treatment

University of Bergen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年10月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •16-25 years old
  • •lives in the Bergen area
  • •has Delayed Sleep Phase Disorder

排除标准

  • •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

研究组 & 干预措施

Melatonin

Active Comparator

Melatonin 3 mg + placebo red light 400 lux

干预措施: Placebo red light (Other)

Combination

Active Comparator

Bright light 10.000 lux + melatonin 3 mg

干预措施: Bright light (Other)

Bright light

Active Comparator

Bright light 10.000 lux + placebo capsule 3 mg rice flour

干预措施: Bright light (Other)

Bright light

Active Comparator

Bright light 10.000 lux + placebo capsule 3 mg rice flour

干预措施: Placebo capsule (Other)

Placebo

Placebo Comparator

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

干预措施: Placebo red light (Other)

Placebo

Placebo Comparator

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

干预措施: Placebo capsule (Other)

Melatonin

Active Comparator

Melatonin 3 mg + placebo red light 400 lux

干预措施: Melatonin (Dietary Supplement)

Combination

Active Comparator

Bright light 10.000 lux + melatonin 3 mg

干预措施: Melatonin (Dietary Supplement)

结局指标

主要结局

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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bjorn Bjorvatn

Professor, MD, PhD

University of Bergen

研究点 (1)

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