Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2024-03-20
2025-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
Amplify-RHYTHM will consist of two main components: 1) timed light exposure, 2) weekly remote coaching session.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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%)
40 Years
65 Years
ALL
No
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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Locations
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University of Illinois at Chicago
Chicago, Illinois, United States
Countries
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Other Identifiers
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2023-1387
Identifier Type: -
Identifier Source: org_study_id
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