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OpenTrials
Completed

NCT Number: NCT06183476

Circadian Amplification in Diabetic Retinopathy

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

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

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

Primary outcomes

  1. Sleep

    Time frame: baseline and 6-week

    Objective and Subjective Sleep Parameters

Secondary outcomes

  1. Salivary melatonin and cortisol

    Time frame: baseline and 6-week

    Evening salivary melatonin and cortisol

  2. Glucose levels

    Time frame: baseline and 6-week

    Glucose from continuous glucose monitoring

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2023
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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