COMPLETED

Circadian Amplification in Diabetic Retinopathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Circadian Amplification in Diabetic Retinopathy

Quick Facts

Study Start:2024-03-20

Study Completion:2025-01-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06183476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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%)

Inclusion Criteria

Exclusion 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.

* 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%)

Contacts and Locations

Study Locations (Sites)

University of Illinois at Chicago

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-20

Study Completion Date2025-01-10

Study Record Updates

Study Start Date2024-03-20

Study Completion Date2025-01-10

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Retinopathy