Status:
COMPLETED
Glasses for Adolescent Delayed Sleep-Wake Phase Disorder
Lead Sponsor:
Mayo Clinic
Conditions:
Delayed Sleep-Wake Phase Disorder
Eligibility:
All Genders
14-17 years
Phase:
NA
Brief Summary
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) c...
Detailed Description
We propose a 3-week field study that examines the efficacy, acceptance, and compliance of using evening amber glasses to block evening light combined with a stable wake time in adolescents (14-17 year...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Regular school attendance in the setting of a fixed start time.
- Adherence to ICSD-3 DSWPD diagnostic criteria.
- Average spontaneous weekend wake time ≥1 hour than school day wake time.
- 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- Subjects will be withdrawn from the study if the sleep log and wrist monitor activity does not correspond with the sleep schedule identified with the pre-study sleep log.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.
Exclusion
Key Trial Info
Start Date :
February 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04378933
Start Date
February 27 2019
End Date
June 3 2022
Last Update
May 6 2023
Active Locations (2)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905