Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Amber Glasses

+ Clear Lens Glasses

Device
Who is being recruted

Mental Disorders+4

+ Nervous System Diseases

+ Occupational Diseases

From 14 to 17 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2019
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 27, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleGlasses for Adolescent Delayed Sleep-Wake Phase Disorder (GLAD)
NCT04378933
Principal SponsorMayo Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

34 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 14 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersNervous System DiseasesOccupational DiseasesSleep Wake DisordersSleep Disorders, Circadian RhythmDyssomniasChronobiology Disorders

Criteria

4 inclusion criteria required to participate
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.
6 exclusion criteria prevent from participating
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).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will wear glasses with amber lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use is reached. Participants will also be required to wake up at the same time (±30 mins).

Group II

Active Comparator
Participants will wear identically appearing glasses with clear lenses beginning 7 hours before average baseline mid-sleep time until the time of intended sleep onset or until a duration of 7 hours of use is reached. Participants will not be given instructions regarding sleep schedule.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Rush University Medical Center

Chicago, United StatesOpen Rush University Medical Center in Google Maps
Suspended

Mayo Clinic in Rochester

Rochester, United States
Completed2 Study Centers