N/A
N=34
Glasses for Adolescent Delayed Sleep-Wake Phase Disorder
Delayed Sleep-Wake Phase Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04378933 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Change in School Night Sleep Onset Time — 0.4; 0.6 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amber Glasses (Device); Clear Lens Glasses (Device)
- Age
- Pediatric · 14+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in School Night Sleep Onset Time |
0.4; 0.6 | — |
| PRIMARY Change in Non-school Night Sleep Onset Time |
1.1; 0.03 | — |
| PRIMARY Change in Dim Light Melatonin Onset (DLMO) |
21.51; 22.36; 21.11; 23.05 | — |
| PRIMARY Change in Dim Light Melatonin Onset (DLMO) Phase Shift |
1.0; 0.4 | — |
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) compared to the control group.
Eligibility Criteria
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- Subjects will be withdrawn from the study if the sleep log and wrist monitor activity does not correspond with the sleep schedule identified with the pre-study sleep log.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.
Data sourced from ClinicalTrials.gov (NCT04378933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.