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Amplify-RHYTHM for Diabetic Retinopathy

N/A
Recruiting
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with type 2 diabetes
Patients with a history of at least moderate non-proliferative diabetic retinopathy
Must not have
Chronic obstructive pulmonary disease requiring oxygen
Severe chronic liver disease such as cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6-week
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a 6-week intervention called Amplify-RHYTHM to see how it affects patients with diabetic retinopathy. They will measure things like sleep quality, hormone levels, and

Who is the study for?
This trial is for individuals with diabetic retinopathy, a condition affecting the eyes due to diabetes. Participants should be interested in trying a new intervention called Amplify-RHYTHM for 6 weeks to potentially improve their sleep and biological rhythms.
What is being tested?
The study is testing Amplify-RHYTHM, an intervention designed to optimize circadian rhythms over a period of 6 weeks. It aims to assess changes in sleep quality, stress hormones like cortisol and melatonin, as well as blood sugar levels using continuous monitoring.
What are the potential side effects?
Potential side effects are not specified but may include discomfort or changes in sleep patterns due to the adjustment of daily routines or dietary habits as part of the circadian optimization process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type 2 diabetes.
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I have had moderate diabetic eye disease in the past.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need oxygen for my chronic lung condition.
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I have severe liver disease, like cirrhosis.
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I am currently taking melatonin.
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I am currently taking antipsychotic medication.
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I am on dialysis for end-stage kidney disease.
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I have had a stroke or a mini-stroke before.
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I am currently receiving treatment for a major medical condition.
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I have serious eye problems.
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I have severe sleep apnea that has not been treated.
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My diabetes is not under control (A1C is 11% or higher).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6-week
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6-week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep
Secondary study objectives
Glucose levels
Salivary melatonin and cortisol

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Amplify-RHYTHM will consist of two main components: 1) timed light exposure, 2) weekly remote coaching session.

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Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,569,089 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
36 Patients Enrolled for Diabetic Retinopathy
~19 spots leftby Feb 2026
Unbiased ResultsWe believe in providing patients with all the options.
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