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Recruiting NCT06949644

Pupillometry in Delayed Sleep Wake Phase Disorder

No phase Interventional 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: Light and Citalopram.
Who it may be relevant to
Registry conditions: Delayed Sleep-Wake Phase Disorder. Basic parameters: from 16 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 →
Official title

Pupillometry in DSWPD Type 1 and Type 2

Overview

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.

Interventions

  • Combination product Light and Citalopram
    Participants will receive placebo or citalopram, followed by bright light exposure

Primary outcome measures

  • Melatonin suppression [Time frame: 8 hours]

Eligibility criteria

Inclusion criteria

  • Delayed sleep-wake phase disorder

Exclusion criteria

  • 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
  • Caffeine consumption >400mg/day

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Northwestern University — Chicago

Identifiers

NCT: NCT06949644 · STU00221304 · R01HL174661

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗