Glasses for Adolescent Delayed Sleep-Wake Phase Disorder

  • STATUS
    Recruiting
  • participants needed
    28
  • sponsor
    Mayo Clinic
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Updated on 16 February 2024
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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.

Description

We propose a 3week 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 (1417 years) with DSWPD (International Classification of Sleep Disorders [ICSD3] 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 CoI 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 clearlensed 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.

Details
Condition Delayed Sleep-Wake Phase Disorder
Age 14years - 17years
Treatment Amber Glasses, Clear Lens Glasses
Clinical Study IdentifierNCT04378933
SponsorMayo Clinic
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Regular school attendance in the setting of a fixed start time
Adherence to ICSD3 DSWPD diagnostic criteria
Average spontaneous weekend wake time 1 hour than school day wake time
Initiation of schoolnight sleep at 12 a.m. or later, 50% of the time, during a 14day period (items 34 to be determined by sleep logs and actigraphy). As there are no discrete clock times associated with the ICSD3 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, nonsteroidal antiinflammatory 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
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