Pathophysiology of Circadian Rhythm Delayed Sleep Wake Phase Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Delayed Sleep Phase Syndrome; Delayed Sleep Phase
• Intervention / Treatment: Behavioral: Circadian rhythm assessment; Behavioral: Light sensitivity assessment

Detailed Description

• The research parts of the study are 6.5 weeks long and the study, including screening visits, involves 6 in-person visits to the Boulder campus.

• If participants qualify for the study and choose to participate, there will be two visits where participants will pick up research equipment to wear at home for 1-2 weeks of ambulatory monitoring before being studied in the laboratory. The first ambulatory monitoring session is for 2 weeks and the second is one week.

  • On the first ambulatory monitoring session the investigators will have participants answer questions about participant's mood and cognition.
  • On both ambulatory monitoring sessions, the investigators will also ask participants to wear a blood sugar monitor and track the timing of when participants eat using a phone app. The investigators will also have participants wear a wrist worn sleep and light monitor plus a daily sleep log and Google form of when participants go to bed and wake up.

• Next will be a visit where participants will spend 66 hours (2.75 days) in the laboratory.

  • While living in the lab, participants will not be aware of the time of day (e.g., no clocks, internet, cell phones), and the investigators will schedule participant's activities.
  • The investigators will ask participants to remain seated in bed and awake for up to ~39 hours, with the head of the bed raised. Participants will be studied under dim light similar to candlelight.
  • The investigators will frequently take saliva samples for more than 24 hours when the investigators will ask participants to stay awake. The investigators will also take four blood samples.
  • The investigators will also ask participants to perform reaction time tests, tests of participant's ability to think, and to complete ratings of how participants feel multiple times each day that participants are in the lab.
  • The investigators will also record participant's brain wave activity, muscle activity, eye movements, and heart rate when participants stay awake and during ~9h sleep opportunities.
• The investigators will then ask participants to sleep normally at home for ~2 weeks, followed by 1 week of ambulatory monitoring.

• Finally, there will be a visit where participants will spend 48 hours (2 days) in the laboratory.

  • While living in the lab, participants will not be aware of the time of day (e.g., no clocks, internet, cell phones) and the investigators will schedule participant's activities.
  • The investigators will expose participants to different light levels (dim light similar to candlelight and typical room light).
  • The investigators will frequently take saliva samples.
  • The investigators will also ask participants to perform reaction time tests, tests of participant's ability to think, and to complete ratings of how participants feel multiple times each day that participants are in the lab.
  • The investigators will also record participant's brain wave activity, muscle activity, eye movements, and heart rate when participants are awake and while participants sleep.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenneth Wright, PhD; Phone Number: 303-735-1923; Email: sleep.study@colorado.edu

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80303
      • Recruiting
      • University of Colorado
      • Contact: Kenneth Wright, PhD; Phone Number: 303-735-1923; Email: sleep.study@colorado.edu
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Phyllis Zee, MD, PhD; Phone Number: 312-695-7950
      • Principal Investigator: Phyllis Zee, MD, PhD
      • Sub-Investigator: Kathryn Reid, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Assessment; Circadian rhythms and light sensitivity

Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin temperature	skin body temperature	Continuously for 1. up to 39 and 2. 23 hours
Melatonin	Melatonin levels in saliva	Hourly for 1. up to 39 hours and 2. every 20 minutes

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Northwestern University
• Investigators: Principal Investigator: Kenneth Wright, PhD, University of Colorado, Boulder

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Chronobiology Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 23-0285; 1R01HL159647-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No