Clinical trial NCT04378933: Glasses for Adolescent Delayed Sleep-Wake Phase Disorder
Official title: Glasses for Adolescent Delayed Sleep-Wake Phase Disorder (GLAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Sleep-Wake Phase Disorder
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 34
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) compared to the control group.

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 years) with DSWPD (International Classification of Sleep Disorders \[ICSD-3\] criteria).3 After 1 week of baseline measurements, subjects will be instructed to wear glasses (which allow 14% entry of ambient light exposure) starting 7 h before individually calculated midsleep time measured during the preceding week. This corresponds to the time when adolescents are most sensitive to phase delaying light according to Co-I Crowley's recently published phase response curve (PRC) to light in adolescents (Figure 1).22 This "amber glasses + stable wake time" group will be compared to a control group: adolescent DSWPD patients who will wear clear-lensed glasses (which allow 100% of ambient light to reach the eyes, otherwise identical in appearance) in the evening at the same times as the alternate group, but without scheduled wake times. Outcome measures will include TST and sleep onset time derived from wrist actigraphy, daytime subjective sleepiness, salivary DLMO, and assessments of acceptance and compliance.

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.

Primary outcomes:
measure: Change in School Night Sleep Onset Time
timeFrame: baseline, week 3
measure: Change in Non-school Night Sleep Onset Time
timeFrame: baseline, week 3
measure: Change in Dim Light Melatonin Onset (DLMO)
timeFrame: baseline, week 3
measure: Change in Dim Light Melatonin Onset (DLMO) Phase Shift
timeFrame: baseline, week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: R. Robert Auger, MD
role: PRINCIPAL_INVESTIGATOR
References: