Circadian Amplification in Diabetic Retinopathy | NCT06183476

Studies
Circadian Amplification in Diabetic Retinopathy

NCT06183476

Sponsor

University of Illinois at Chicago

Status

Completed

Last Update Posted

Aug 11, 2025Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Diabetic Retinopathy

Interventions

Amplify-RHYTHM

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2024Actual

Primary Completion Date

Jan 10, 2025Actual

Completion Date

Jan 10, 2025Actual

First Submitted Date

Dec 13, 2023

First Submission Date that Met QC Criteria

Dec 13, 2023

First Posted Date

Dec 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2025

Last Update Posted Date

Aug 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will test the effects of a 6-week comprehensive circadian optimization intervention Amplify-RHYTHM in patients with diabetic retinopathy. The outcomes of interest are objective and subjective sleep parameters, evening salivary cortisol and melatonin levels, and glucose parameters from continuous glucose monitoring

Detailed Description

This study will test the effects of a 6-week comprehensive circadian optimization intervention Amplify-RHYTHM in patients with diabetic retinopathy. The two main components of the intervention are timed light exposure and weekly remote coaching session by psychologist to optimize circadian and sleep behaviors. The outcomes of interest are objective and subjective sleep parameters, evening salivary cortisol and melatonin levels, and glucose parameters from continuous glucose monitoring

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Amplify-RHYTHM will consist of two main components: 1) timed light exposure, 2) weekly remote coaching session.	Behavioral: Amplify-RHYTHM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amplify-RHYTHM	Behavioral	Amplify-RHYTHM will have two main components: 1) timed light exposure (increase light in the morning, blue light reduction in the evening and eye masks at night), 2) weekly remote coaching session by psychologist to optimize circadian and sleep behaviors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep	Objective and Subjective Sleep Parameters	baseline and 6-week

Secondary Outcomes

Measure	Description	Time Frame
Salivary melatonin and cortisol	Evening salivary melatonin and cortisol	baseline and 6-week
Glucose levels	Glucose from continuous glucose monitoring

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 2 diabetes
a history of at least moderate non-proliferative diabetic retinopathy
would like to improve sleep
own a smartphone compatible with fitbit.

Exclusion Criteria:

Use of melatonin
Use of antipsychotics
Use of more than one antidepressant. The dose of which needs to be stable for 6 weeks.
illicit drug use
night shift work or travel beyond 2 time zones in the month before enrollment
end stage renal disease requiring renal replacement therapy
history of stroke or transient ischemic attacks
history of dementia or memory impairment
uncontrolled congestive heart failure or recent hospitalization for cardiac condition (6 months)
chronic obstructive pulmonary disease requiring oxygen
severe chronic liver disease such as cirrhosis
ongoing treatment for major medical problems such as cancer
history of severe hypoglycemia defined as hypoglycemic episodes requiring assistance from others within the past six months.
Regular use of sedatives and hypnotics (>2 times/ month).
clinically significant epiretinal membranes, clinically significant lens opacities, or cystoid macular edema, iris neovascularization, iris atrophy, or an asymmetrically shaped pupil, nuclear sclerotic, posterior subcapsular, or cortical lens opacities greater than 2+, a history of pan-retinal photocoagulation.
Significant depressive symptoms as assessed by PHQ-8 questionnaire (score >14)
No health insurance coverage
History of untreated severe OSA.
Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg),
Uncontrolled diabetes (A1C ≥ 11%)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases