Optimizing circadian rhythms to improve diabetic retinopathy outcomes
Circadian Amplification in Diabetic Retinopathy
This study is testing a new program that uses light exposure and coaching to help people with diabetic retinopathy improve their sleep and daily rhythms to see if it can benefit their eye health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06183476 on ClinicalTrials.gov |
What this trial studies
This study tests a 6-week intervention called Amplify-RHYTHM aimed at optimizing circadian rhythms in patients with diabetic retinopathy. The intervention includes timed light exposure and weekly remote coaching sessions by a psychologist to enhance sleep and circadian behaviors. The study will measure various outcomes, including sleep parameters, salivary cortisol and melatonin levels, and glucose monitoring data. The goal is to determine if these changes can positively impact the health of patients with diabetic retinopathy.
Who should consider this trial
Good fit: Ideal candidates are individuals with type 2 diabetes and a history of moderate non-proliferative diabetic retinopathy who wish to improve their sleep.
Not a fit: Patients with severe comorbid conditions or those using certain medications that affect sleep or circadian rhythms may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve sleep quality and metabolic parameters in patients with diabetic retinopathy, potentially leading to better disease management.
How similar studies have performed: While the specific approach of circadian optimization in diabetic retinopathy is novel, similar interventions targeting sleep and metabolic health have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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%)
Where this trial is running
Chicago, Illinois
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.