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临床试验/NCT03508245
NCT03508245已完成不适用

Investigating Circadian Rhythms in Youth With Persistent Tic Disorders

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Yale Global Tic Severity Scale (YGTSS)

研究概览

简要总结

This study examines circadian rhythms and morningness-eveningness preference in youth with Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD); and assesses the effects of wearable short wavelength light therapy on circadian rhythms and tic symptoms.

详细描述

Many individuals with Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD) fail to significantly benefit from existing tic treatments. Case studies have shown morning exposure to light therapy, known to advance circadian phase is associated with modest to large tic reductions (Coles & Strauss, 2013; Niederhofer, 2003) suggesting the presence of circadian abnormalities (i.e., phase delay) in select individuals with PTDs. The present project assesses circadian phase and morningness-eveningness preference in youth with Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD), and examines whether morning use of wearable short wavelength light therapy is associated with shifts in circadian rhythms and reductions in tic severity.

Study participation will take place over a three-week period. Clinician-rated tic interview and rating scales of morningness-eveningness preference, sleep, tic, and other symptoms will be completed during an initial screening assessment. Participants will then monitor sleep at home using an actigraph for one week and return for a baseline clinical assessment of tic severity and evening assessment of internal melatonin levels involving saliva sampling every 30 minutes for 6.5 hours in a dimly lit room. Next, participants will complete an abbreviated course (i.e., two weeks) of morning light therapy using wearable short wavelength (i.e., blue-green) light-emitting glasses while continuing to monitor sleep using the actigraph. Following this two-week period participants will return for a final assessment of tic severity and internal melatonin levels.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • DSM-5 diagnosis of Tourette's Disorder, Persistent Motor Tic Disorder, or Persistent Vocal Tic Disorder
  • Yale Global Tic Severity Scale Score ≥ 14 for Tourette's Disorder or ≥ 10 for Persistent Motor Tic Disorder or Persistent Vocal Tic Disorder
  • fluency in English

排除标准

  • Current or lifetime diagnosis of Bipolar Disorder, psychosis, or autism spectrum disorder
  • Suicidality, severe depression or anxiety (i.e., Depression or anxiety diagnosis is more severe than Tourette's Disorder; equivalence in severity is allowed), or substance dependence, present within the past 6 months
  • Current diagnosis of Obstructive Sleep Apnea, Restless leg syndrome, Periodic Limb Movement Disorder, or Narcolepsy
  • Intellectual functioning below the low average range (WASI-II IQ score < 80)
  • Hypnotic medications, or melatonin within 8 weeks of study enrollment
  • Changes in dosage of any psychiatric medications within the past month
  • Behavior therapy for tics within the past 3 months
  • Prior use of light therapy
  • Current pregnancy or travel across > 2 time zones in the past month
  • Medical or neurological condition (e.g., seizure disorder, migraines) that would interfere in the individual's ability to participate in the study

结局指标

主要结局

Yale Global Tic Severity Scale (YGTSS)

时间窗: 2 weeks

The YGTSS (Leckman et al., 1989) is a clinician-administered measure of tic severity encompassing tic number, frequency, intensity, complexity, and interference. The measure yields independent severity ratings for motor and vocal tics, a combined total tic severity score (0 to 50), and an independent tic-related impairment score (0 to 50).

Dim Light Melatonin Onset

时间窗: 2 weeks

The clock time at which salivary melatonin concentration reaches a threshold of 4 picograms (pg) per milliliter.

次要结局

  • Parent Tic Questionnaire (PTQ)(2 weeks)
  • Clinical Global Impression-Improvement (CGI-I) Scale(2 weeks)
  • Children's Morningness-Eveningness Preferences Scale (CMEP)(2 weeks)

研究者

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

Emily J. Ricketts, PhD

Principal Investigator

University of California, Los Angeles

研究点 (2)

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