Health TrialsbyHealthPanel

Pathophysiology of Circadian Rhythm Delayed Sleep Wake Phase Disorder

ConditionsDelayed Sleep Phase SyndromeDelayed Sleep Phase
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorUniversity of Colorado, Boulder

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Delayed sleep wake phase disorder diagnosis

Altitude history: currently residing at Denver altitude or higher

BMI normal to moderately overweight

Disqualifiers

Recent medical condition

Psychiatric disorder

Sleep disorder

Medication use

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: AssessmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Core body temperature

Body temperature measured with a pill

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

Glucose

Blood sugar levels

Time frame
Continuously for 1. up to 39 and 2. 23 hours
3

Subjective sleepiness

Self reported sleepiness

Time frame
Every 2 hours
4

Psychomotor vigilance

Attention/Vigilance performance

Time frame
Every 2 hours

Secondary outcomes

1

Skin temperature

skin body temperature

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

Melatonin

Melatonin levels in saliva

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Boulder

Lead sponsor

Northwestern University

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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