Circadian Amplification in Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

Circadian Amplification in Diabetic Retinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183476
• Other study ID #: 2023-1387
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Behavioral:
• Amplify-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

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep	Objective and Subjective Sleep Parameters	baseline and 6-week
Secondary	Salivary melatonin and cortisol	Evening salivary melatonin and cortisol	baseline and 6-week
Secondary	Glucose levels	Glucose from continuous glucose monitoring	baseline and 6-week