Pupillometry in Delayed Sleep Wake Phase Disorder

NCT ID: NCT06949644

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2029-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Delayed Sleep-Wake Phase Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DSWPD

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

Group Type EXPERIMENTAL

Light and Citalopram

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Light and Citalopram

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Sabra Abbott

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sabra Abbott, MD, PhD

Role: CONTACT

312-503-3561

Other Identifiers

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R01HL174661

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00221304

Identifier Type: -

Identifier Source: org_study_id

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