Circadian Amplification in Diabetic Retinopathy

NCT06183476 | Completed

• 1 other identifier: 2023-1387
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Sleep

  Objective and Subjective Sleep Parameters

  baseline and 6-week

Secondary Outcomes (2)

• Salivary melatonin and cortisol

  baseline and 6-week

• Glucose levels

  baseline and 6-week

Study Arms (1)

Intervention

EXPERIMENTAL

Amplify-RHYTHM will consist of two main components: 1) timed light exposure, 2) weekly remote coaching session.

Behavioral: Amplify-RHYTHM

Interventions

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

Intervention

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Amplify-RHYTHM focuses on timed light exposure and weekly remote coaching session to optimize circadian and sleep behaviors.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: March 20, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: August 11, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)