Evening Use of Polarized Glasses to Filter Out Blue Light in Attention Deficit Hyperactivity Disorder - Delayed Circadian Rhythm Disorder Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Attention Deficit Hyperactivity Disorder Delayed Circadian Rhythm Disorder |
Device: Polarized glasses designed to filter out blue light |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evening Use of Polarized Glasses Designed to Filter Out Blue Light in Attention Deficit Hyperactivity Disorder - Delayed Circadian Rhythm Disorder Patients |
- 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.
- 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.
| Enrollment: | 22 |
| Study Start Date: | September 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
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Device: Polarized glasses designed to filter out blue light
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 19 years of age and older
- Diagnosis of ADHD and DCRD
- Willingness to sign consent and participate in the study
Exclusion Criteria:
- No sleep medication for previous two weeks before screen visit (Can enroll if willing to undergo washout period)
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | Rachel Fargason, MD | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | Rachel Fargason, MD, MD, Associate Professor Psychiatry, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01557595 History of Changes |
| Other Study ID Numbers: | X110825016 |
| Study First Received: | February 16, 2012 |
| Last Updated: | October 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Chronobiology Disorders Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methamphetamine Sympathomimetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013