Glasses for Adolescent Delayed Sleep-Wake Phase Disorder (GLAD)

Overview

About this study

The purpose of this study is to determine if evening amber glasses combined with stable wake times will show an increase in total sleep time (TST), and an advance in sleep onset times (shift earlier) compared to the control group.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  1. Regular school attendance in the setting of a fixed start time.
  2. Adherence to ICSD‐3 DSWPD diagnostic criteria.
  3. Average spontaneous weekend wake time ≥1 hour than school day wake time.
  4. Initiation of school‐night sleep at 12 a.m. or later, ≥50% of the time, during a 14‐day period (items 3‐4 to be determined by sleep logs and actigraphy). As there are no discrete clock times associated with the ICSD‐3 DSWPD description, this cutoff is based on data obtained from the 2006 Sleep in America Poll and experiences gleaned from prior recruitment.

Exclusion Criteria:

  • A positive urine drug abuse screen will disqualify the individual from further participation.
  • Subjects will be withdrawn from the study if the sleep log and wrist monitor activity does not correspond with the sleep schedule identified with the pre-study sleep log.
  • Alcohol and nicotine use will also be screened to qualify for the study. We will also screen for alcohol immediately before each DLMO assessment because alcohol acutely suppresses melatonin.
  • Patients receiving medications that might contribute to sleep disturbances and/or affect treatment responses will be considered ineligible (e.g., hypnotics, antidepressants, stimulants, non‐steroidal anti‐inflammatory drugs (NSAIDs), beta blockers).
  • All subjects will be asked to refrain from caffeine use on the days of phase assessments, and to cease ingestion at least 6 hours prior to nightly bedtime.
  • The Ishihara Color Blindness Test will be done and patients who are color blind/deficient will be disqualified from participating in the study.

 

           

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

R Auger, M.D.

Open for enrollment

Contact information:

Deanna Hofschulte CCRP

(507) 255-2972

Hofschulte.Deanna@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available