NCT04378933

Glasses for Adolescent Delayed Sleep-Wake Phase Disorder

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 14 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Delayed Sleep-Wake Phase Disorder

Interventions

Type	Name	Description
DEVICE	Amber Glasses	Half of the participants will be wearing the amber glasses to see if they can help with sleep onset.
DEVICE	Clear Lens Glasses	Half of the participants will be wearing the clear glasses to see if the glasses help with sleep onset.

Timeline

• Start date: 2019-02-27
• Primary completion: 2022-06-03
• Completion: 2022-06-03
• First posted: 2020-05-07
• Last updated: 2023-05-06
• Results posted: 2023-05-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study