Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT01557595
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2012-02-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Blue Wavelength Light-blocking Glasses in ADHD-Insomnia
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Evening Use of Polarized Glasses Designed to Filter Out Blue Light in Attention Deficit Hyperactivity Disorder - Delayed Circadian Rhythm Disorder Patients
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADHD
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.
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 + 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: