Circadian Amplification in Diabetic Retinopathy

Not Applicable

Recruiting

• Conditions: Diabetic Retinopathy
• Interventions: Behavioral: Amplify-RHYTHM

• Registration Number: NCT06183476
• Lead Sponsor: University of Illinois at Chicago

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

Study Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-27
• Study Start: 2024-03-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2026-02
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Amplify-RHYTHM	Amplify-RHYTHM will consist of two main components: 1) timed light exposure, 2) weekly remote coaching session.

Primary Outcome Measures

Name	Time	Method
Sleep	baseline and 6-week	Objective and Subjective Sleep Parameters

Secondary Outcome Measures

Name	Time	Method
Salivary melatonin and cortisol	baseline and 6-week	Evening salivary melatonin and cortisol
Glucose levels	baseline and 6-week	Glucose from continuous glucose monitoring

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States