Blue Wavelength Light-blocking Glasses in ADHD-Insomnia

Attention Deficit Hyperactivity Disorder Clinical Trial

— ADHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557595
• Other study ID #: X110825016
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: December 12, 2017
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2017
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Delayed Sleep Phase Type Circadian Rhythm Sleep Disorder
• Disease
• Hyperkinesis
• Parasomnias
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index (PSQI) at 2 Weeks After 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.	2 weeks post baseline