Circadian Amplification in Diabetic Retinopathy

Study Overview
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Brief Summary
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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
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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

Official Title
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Circadian Amplification in Diabetic Retinopathy

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Behavioral: Amplify-RHYTHM


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Amplify-RHYTHM focuses on timed light exposure and weekly remote coaching session to optimize circadian and sleep behaviors.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Amplify-RHYTHM will consist of two main components: 1) timed light exposure, 2) weekly remote coaching session. | Behavioral: Amplify-RHYTHM<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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