Circadian Amplification in Diabetic Retinopathy

University of Illinois

Status

Completed

Conditions

Diabetic Retinopathy

Treatments

Behavioral: Amplify-RHYTHM

Study type

Interventional

Funder types

Other

Identifiers

NCT06183476

2023-1387

Details and patient eligibility

About

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

Full 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

Enrollment

8 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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%)