Pupillometry in Delayed Sleep Wake Phase Disorder

NCT06949644 | Recruiting

• 2 other identifiers: STU00221304R01HL174661
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delayed Sleep-Wake Phase Disorder

Outcome Measures

Primary Outcomes (1)

• Melatonin suppression

  Saliva melatonin samples will be collected before and after light exposure

  8 hours

Study Arms (1)

DSWPD

EXPERIMENTAL

Placebo or Citalopram followed by bright light (all participants will receive both interventions in random order).

Combination Product: Light and Citalopram

Interventions

Light and Citalopram COMBINATION_PRODUCT

Participants will receive placebo or citalopram, followed by bright light exposure

DSWPD

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Delayed sleep-wake phase disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Light; Citalopram

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Sabra Abbott, MD, PhD

CONTACT

312-695-7950; sabra.abbott@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)