Pathophysiology of Circadian Rhythm Delayed Sleep Wake Phase Disorder

NCT06471374 | Recruiting

• 2 other identifiers: 23-02851R01HL159647-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• Core body temperature

  Body temperature measured with a pill

  Continuously for 1. up to 39 and 2. 23 hours

• Glucose

  Blood sugar levels

  Continuously for 1. up to 39 and 2. 23 hours

• Subjective sleepiness

  Self reported sleepiness

  Every 2 hours

• Psychomotor vigilance

  Attention/Vigilance performance

  Every 2 hours

Secondary Outcomes (2)

• Skin temperature

  Continuously for 1. up to 39 and 2. 23 hours

• Melatonin

  Hourly for 1. up to 39 hours and 2. every 20 minutes

Study Arms (1)

Assessment

EXPERIMENTAL

Circadian rhythms and light sensitivity

Behavioral: Circadian rhythm assessment; Behavioral: Light sensitivity assessment

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.

Assessment

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.

Assessment

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• Northwestern University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Colorado

Boulder, Colorado, 80303, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Officials

• Kenneth Wright, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Wright, PhD

CONTACT

303-735-1923; sleep.study@colorado.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

US (2)