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Sleep and Light Therapy for Circadian Rhythm Disorder (CARRS-P2 Trial)

N/A

Recruiting

Led By Brant Hasler, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Significant or unstable acute or chronic medical conditions

Family history of bipolar disorder among first degree relative

Timeline

Screening 3 weeks

Treatment Varies

Follow Up continuously up to every 6 months for up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test an innovative and mechanistic model of brain circuitry that uses multi-method approaches, takes a developmental perspective, and incorporates key sleep and reward constructs.

Who is the study for?

This trial is for healthy teens typically enrolled in high school, who go to bed later than 11:15 PM and are not homeschooled. They can't have metal in their body, be pregnant, have unstable medical conditions, recent changes to psychotropic meds, extreme late sleep patterns, frequent headaches or migraines, a history of substance use or serious psychiatric disorders.

What is being tested?

The study explores how manipulating sleep and circadian rhythms affects reward function in adolescents. It involves monitoring sleep patterns and mood while adjusting light exposure (more bright light in the morning; less blue light at night) and managing sleep schedules.

What are the potential side effects?

There may be no direct side effects from the interventions since they involve non-invasive techniques like adjusting light exposure and modifying sleep schedules. However, changing one's routine could temporarily affect mood or alertness.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe or unstable health conditions.

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A close family member has bipolar disorder.

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I do not have any sleep disorders needing ongoing treatment.

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I have a history of seizures.

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I often experience headaches or migraines.

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I have a sleep disorder that is not insomnia or delayed sleep phase disorder.

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I am not taking medications that increase sensitivity to light.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuously up to every 6 months for up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~continuously up to every 6 months for up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and continuously up to every 6 months for up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in Circadian alignment at 2 weeks

Change from baseline in Sleep timing at 2 weeks

Change from baseline in behavioral inhibition at 2 weeks

+4 more

Secondary study objectives

Caffeine use

Substance use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Advance/Extend ManipulationExperimental Treatment4 Interventions

For \~2 weeks, Advance/Extend participants will advance bedtime and regularize wake time. The first night of the manipulation will be conducted in the lab under tightly-controlled experimental conditions. Participants will then go home and for the next 12 days will be instructed to: * Sleep scheduling-- advance bedtime by 1.5 hours ( + sleep duration) * Decrease evening blue light exposure via blue blocker goggles (2 hrs before bed) * Increase morning bright light exposure via bright light goggles (30 min after rise) * Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph

Group II: ControlActive Control1 Intervention

Control participants will complete the baseline laboratory study, then maintain their habitual sleep schedules over the next 13 days at home, with no instruction on sleep timing or light exposure. Control participants will complete smartphone-and text-based assessments, thereby controlling for effort.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Monitor sleep, mood, and substance use

2018

N/A

~150

0 / 7Eligibility criteria met