Diabetic Retinopathy
Conditions
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
Interventions
BEHAVIORALAmplify-RHYTHM
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
Sponsors
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Amplify-RHYTHM focuses on timed light exposure and weekly remote coaching session to optimize circadian and sleep behaviors.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep | baseline and 6-week | Objective and Subjective Sleep Parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose levels | baseline and 6-week | Glucose from continuous glucose monitoring |
| Salivary melatonin and cortisol | baseline and 6-week | Evening salivary melatonin and cortisol |
Countries
United States
Outcome results
None listed