Pupillometry in Delayed Sleep Wake Phase Disorder
ConditionDelayed Sleep-Wake Phase Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorNorthwestern University
About this trial
The goal of this observational study is to characterize the pupil light response in patients with delayed sleep-wake phase disorder. A subset of participants will take part in a clinical trial to determine if increasing serotonin can alter the circadian response to light. The main questions it aims to answer is:
Are there differences in the light response in patients with delayed sleep-wake phase disorder? Does citalopram increase melatonin suppression in patients with delayed sleep-wake phase disorder?
Participants will complete activity and melatonin testing at home to determine their circadian timing. This will be followed by an eye test looking at the pupil response to different light stimuli. A subset of participants will complete two inpatient admissions where melatonin levels will be sampled and they will be exposed to a bright light. During one round of testing they will receive a placebo and in the other round of testing they will take a single dose of citalopram, a selective serotonin reuptake inhibitor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Delayed sleep-wake phase disorder
Disqualifiers
Use of medications known to alter pupil diameter
History of eye disease or eye surgery
Unstable medical or psychiatric condition
Shift work or self imposed irregular sleep schedules
Trial design
Design model
Single group
Treatments tested in this trial
Light and Citalopram
Combination productParticipants will receive placebo or citalopram, followed by bright light exposure
Treatment groups
220 Participants
are divided into 1 treatment groupGroup A: DSWPDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Melatonin suppression
Saliva melatonin samples will be collected before and after light exposure
Time frame
8 hoursSponsors and contacts
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Northwestern University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov