Recruiting

Observational Study

Sponsor:

University of Colorado, Boulder

Code:

NCT06471374

Conditions

Delayed Sleep Phase Syndrome

Delayed Sleep Phase

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Accepted

Interventions

Circadian rhythm assessment

Light sensitivity assessment

Study Details

Brief summary:

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.

Conditions

Delayed Sleep Phase Syndrome

Delayed Sleep Phase

Study ID

NCT06471374

Start date

Apr 2, 2024

Status verified date

Jun, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Delayed sleep wake phase disorder diagnosis
  • Altitude history: currently residing at Denver altitude or higher
  • BMI normal to moderately overweight

Exclusion Criteria:

  • Recent medical condition
  • Psychiatric disorder
  • Sleep disorder
  • Medication use

Study Design

Enrollment

66 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Assessment

Circadian rhythms and light sensitivity

Interventions

Circadian rhythm assessment

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

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.

Primary outcome measure

  • Core body temperature [ Time Frame: Continuously for 1. up to 39 and 2. 23 hours ]
  • Glucose [ Time Frame: Continuously for 1. up to 39 and 2. 23 hours ]
  • Subjective sleepiness [ Time Frame: Every 2 hours ]
  • Psychomotor vigilance [ Time Frame: Every 2 hours ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado

Recruiting

Boulder, Colorado, United States, 80303

Contacts

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Phyllis Zee, MD, PhD

(312) 695-7950

Principal Investigator:

Phyllis Zee, MD, PhD

More Information

Sponsor

University of Colorado, Boulder

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Boulder on 2026-06-17.