Pathophysiology of Circadian Rhythm Delayed Sleep Wake Phase Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Circadian rhythm assessment, Light sensitivity assessment.
- Who it may be relevant to
- Registry conditions: Delayed Sleep Phase Syndrome, Delayed Sleep Phase. Basic parameters: 16 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- 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 - 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 ti
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Skin temperature [Time frame: Continuously for 1. up to 39 and 2. 23 hours]
- Melatonin [Time frame: Hourly for 1. up to 39 hours and 2. every 20 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- University of Colorado — Boulder
- Northwestern University — Chicago
Identifiers
NCT: NCT06471374 · 23-0285 · 1R01HL159647-01