Pathophysiology of Circadian Rhythm Delayed Sleep Wake Phase Disorder

Part of paid clinical trials in Boulder, Colorado.

Sponsor
University of Colorado, Boulder
Study ID
NCT06471374
Status
Recruiting
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Conditions

  • Delayed Sleep Phase
  • Delayed Sleep Phase Syndrome

Eligibility Criteria

Sex
ALL
Age
16 Years - 30 Years
Healthy Volunteers
Accepted

Interventions

  • Circadian rhythm assessment — BEHAVIORAL
    Participants will arrive approximately 8 hours before participant's scheduled bedtime to practice ability to think testing and a 9-hour sleep study. Participants will live in the laboratory for approximately 66 hours (2.75 days). Upon awakening in the morning, participants will start a routine of up to 39 hours of wakefulness, under bedrest conditions. Saliva will be sampled frequently and blood will be drawn 3 times. Reaction time, ability to think, and subjective rating tests will be performed frequently. Participants will be provided scheduled bathroom breaks when participants will use a commode next to the bed. Outside these scheduled bathroom breaks, participants will be provided a bedpan to use to go to the bathroom. At the end of the research procedures for Visit 4 participants will be given a recovery sleep opportunity and be discharged from the lab in the morning near participant's typical waketime.
  • Light sensitivity assessment — BEHAVIORAL
    Participants will arrive in the afternoon to practice ability to think testing and a 9-hour sleep study. Participants will live in the laboratory for approximately 48 hours (2 days). Upon awakening in the morning, participants will be exposed to dim candlelight and then later in the day alternating intensities of dim and room light when we keep participants awake for up to 23 hours (We will ask participants to remain in bed seated for \~12.5 hours). Saliva will be sampled frequently. Reaction time, ability to think, and subjective rating tests will be performed frequently. Participants will then have a second 9-hour sleep opportunity.

Study Details

The goal of this study is to understand factors that contribute to delayed sleep wake phase disorder (DSWPD). The investigators will examine whether patients with DSWPD exhibit alterations in circadian rhythms and sensitivity to light compared to healthy controls. The investigators will also test a new method of predicting circadian rhythms form a blood sample.

Key Dates

Start date
Apr 2, 2024
Status verified
Jun 2024
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Assessment
    Circadian rhythms and light sensitivity

Primary Outcome Measure

Core body temperature [ Time Frame: Continuously for 1. up to 39 and 2. 23 hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ColoradoBoulderColorado80303
Kenneth Wright, PhD
[email protected]
303-735-1923
Northwestern UniversityChicagoIllinois60611
Phyllis Zee, MD, PhD
312-695-7950
Phyllis Zee, MD, PhD (PRINCIPAL_INVESTIGATOR)
Kathryn Reid, PhD (SUB_INVESTIGATOR)

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By research site
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