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Blue Wavelength Light-blocking Glasses in ADHD-Insomnia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rachel Fargason, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01557595
First received: February 16, 2012
Last updated: September 5, 2014
Last verified: September 2014

February 16, 2012
September 5, 2014
September 2011
June 2012   (final data collection date for primary outcome measure)
Change in Pittsburgh Sleep Quality Index (PSQI) at 2 Weeks After Baseline [ Time Frame: Change from baseline in PSQI at 2 weeks ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT01557595 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Blue Wavelength Light-blocking Glasses in ADHD-Insomnia
Evening Use of Polarized Glasses Designed to Filter Out Blue Light in Attention Deficit Hyperactivity Disorder - Delayed Circadian Rhythm Disorder Patients

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder
  • Delayed Sleep Phase Type Circadian Rhythm Sleep Disorder
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
Experimental: Adults with ADHD
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
Intervention: Device: Polarized glasses designed to filter out blue light
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 2012
June 2012   (final data collection date for primary outcome measure)

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)
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01557595
X110825016
No
Rachel Fargason, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: Rachel Fargason, MD University of Alabama at Birmingham
University of Alabama at Birmingham
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP