Evening Use of Polarized Glasses to Filter Out Blue Light in Attention Deficit Hyperactivity Disorder - Delayed Circadian Rhythm Disorder Patients
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| First Received Date ICMJE | February 16, 2012 | ||||
| Last Updated Date | October 16, 2012 | ||||
| Start Date ICMJE | September 2011 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from baseline in PSQI at 2 weeks ] [ Designated as safety issue: No ] If the participant has not been on sleep medications for the last two weeks, they will receive 7 sets of Wake Up and Bedtime Diaries at the screen visit and will be instructed to complete them twice daily. At the baseline visit (1 week after the screen visit), participants will complete the PSQI in reference to the last month. After 14 days of glasses wear every evening, participants will return for a termination visit. At the termination visit, participants will complete the PSQI in reference to the last week. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01557595 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Wake Up and Bedtime Diaries [ Time Frame: Change from baseline in diaries at 2 weeks ] [ Designated as safety issue: No ] At the screen visit, participants will receive 7 sets of Wake Up and Bedtime Diaries and be instructed to complete them twice daily. At the baseline visit, the completed diaries will be retrieved, and participants will be given 14 sets of Wake Up and Bedtime Diaries. Participants will also be given the polarized glasses to wear from sundown until bedtime for 2 weeks. Diaries will be filled out daily for 2 weeks. All forms will be collected with the glasses after the 2 weeks, at the termination visit. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evening Use of Polarized Glasses to Filter Out Blue Light in Attention Deficit Hyperactivity Disorder - Delayed Circadian Rhythm Disorder Patients | ||||
| Official Title ICMJE | Evening Use of Polarized Glasses Designed to Filter Out Blue Light in Attention Deficit Hyperactivity Disorder - Delayed Circadian Rhythm Disorder Patients | ||||
| Brief Summary | 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. |
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| Detailed Description | 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 + DCRD 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Polarized glasses designed to filter out blue light
Participants will be given polarized glasses (yellow "sun"- 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.
Other Name: Lowbluelights.com eyewear |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 22 | ||||
| Completion Date | June 2012 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01557595 | ||||
| Other Study ID Numbers ICMJE | X110825016 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Rachel Fargason, MD, University of Alabama at Birmingham | ||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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