跳至主要内容
临床试验/NCT01557595
NCT01557595已完成不适用

Evening Use of Polarized Glasses Designed to Filter Out Blue Light in Attention Deficit Hyperactivity Disorder - Delayed Circadian Rhythm Disorder Patients

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2011年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Pittsburgh Sleep Quality Index (PSQI) at 2 Weeks After Baseline

研究概览

简要总结

Patients with ADHD often report staying up late on the computer, watching TV, or using other electronic devices, all strong emitters of blue light which may be contributing to the delayed sleep onset times seen in some of these patients. Evening use of polarizing glasses which filter out blue light may decrease the contribution of environmental light late at night to delayed bedtime. This is a treatment that Dr. Fargason uses when patients do not want to use sleep medication to help them fall asleep. The purpose of this study is to evaluate the effectiveness of this treatment by use of sleep diaries and sleep questionnaires.

详细描述

Blue light in the 460-480 nm range is known to suppress melatonin onset and signal alerting mechanisms in the brain. Patients with ADHD often report staying up late on the computer, watching TV, or using other electronic devices, all strong emitters of blue light which may be contributing to the delayed sleep onset times seen in these patients. (Ramelteon for insomnia due to ADHD, R Fargason, K Gamble, K Avis, R Besing, R May, Psychopharmacology Bulletin, submitted March 2011). Dr. Fargason is using polarized glasses to treat patients who do not want to take sleep medications to facilitate earlier sleep onset.

At the screen visit, following the informed consent procedure, ADHD + Delayed CRSD participants will fill out the demographic sheet and will be interviewed by the investigator regarding their history of sleep medications. If they are currently taking sleep medications and wish to stop taking them in order to participate in the study, they will be instructed how to safely do this. Following a two week washout period, participants will be given 7 wake up and bedtime diaries to complete. If the participant has not been on sleep medications for the last two weeks, they will receive the 7 sets of diaries at the screen visit and instructed to complete them twice daily.

At the baseline visit, the diaries will be retrieved. The participants will complete a baseline Pittsburgh Sleep Quality Index (PSQI), and will be given 14 sets of wake up and bedtime diaries. Participants will also be given polarized glasses which filter out blue light to wear only from sundown until bedtime for two weeks. They will be instructed to turn off fluorescent lights and only use household lamps for evening activities. They will be instructed not to drive while wearing the glasses. In addition to the oral instructions, they will also be given a written "Instruction Sheet." Any oral insomnia agent will be held throughout the study, otherwise they are to follow their usual evening routines. This is an alternative treatment already in use in Dr. Fargason's practice for those patients who don't want to take sleep medications. This research focuses on the effectiveness of this treatment and involves questionnaires to do so.

The diaries will then be filled out daily for 2 weeks; days with extenuating circumstances (i.e. nighttime trip to ER) will be noted; the PSQI will be filled out again at the 2 week termination visit. All forms will be collected with the glasses at the 2 week visit. This data is being gathered in patients who have remained in clinical treatment with Dr. Fargason and view this as an opportunity to have a free trial of the polarizing glasses before purchasing them for their own use to advance their sleep phase. This idea was prompted by the patients' eagerness to try the glasses clinically and hence avoid need for sleep medication.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19 years of age and older
  • Diagnosis of ADHD and DCRD
  • Willingness to sign consent and participate in the study

排除标准

  • No sleep medication for previous two weeks before screen visit (Can enroll if willing to undergo washout period)

研究组 & 干预措施

Adults with ADHD

Experimental

Participants will be given polarized glasses (yellow "sun"- glasses) which filter out blue light to wear only from sundown until bedtime for two weeks. Subjects will 19 years or older and have ADHD

干预措施: Polarized glasses designed to filter out blue light (Device)

结局指标

主要结局

Pittsburgh Sleep Quality Index (PSQI) at 2 Weeks After Baseline

时间窗: 2 weeks post baseline

The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) \< or = 5 associated with good sleep quality; \> 5 associated with poor sleep quality. The PSQI is considered appropriate in identifying "new-onset" insomnia in the clinical setting.

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

Rachel Fargason, MD

MD, Associate Professor Psychiatry

University of Alabama at Birmingham

研究点 (2)

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