Diabetic RetinopathyNCT06183476
Circadian Amplification in Diabetic Retinopathy
A study testing Amplify-RHYTHM in people with Diabetic Retinopathy, run by University of Illinois Chicago at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Amplify-RHYTHM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- a history of at least moderate non-proliferative diabetic retinopathy
- would like to improve sleep
- own a smartphone compatible with fitbit.
Who cannot join
- 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
Show all 20Show fewer
- 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%)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
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
Read the 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
- Conditions
- Diabetic Retinopathy
- Being tested
- Amplify-RHYTHM
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplify-RHYTHMBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Amplify-RHYTHM will consist of two main components: 1) timed light exposure, 2) weekly remote coaching session. Receives: Behavioral: Amplify-RHYTHM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Objective and Subjective Sleep Parameters
Measured: baseline and 6-week
Secondary outcomes (3)
Salivary melatonin
Evening salivary melatonin and cortisol
Measured: baseline and 6-week
Glucose levels
Glucose from continuous glucose monitoring
Measured: baseline and 6-week
High sensitivity C-reactive protein
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start20 Mar 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Amplify-RHYTHM focuses on timed light exposure and weekly remote coaching session to optimize circadian and sleep behaviors.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183476
- Sponsor's protocol ID
- 2023-1387
- Status last verified
- May 2024
- First submitted
- 13 Dec 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reutrakul S, McAnany JJ, Park JC, Cross A, Danielson KK, Van Cauter E, Hanlon EC, Law J, Pratuangtham S, Chau FY, Baron KG, Priyadarshini M, Duffecy J. Circadian rhythm amplification in diabetic retinopathy: a pilot study. Sleep Adv. 2026 Aug 20;7(3):zpag091. doi: 10.1093/sleepadvances/zpag091. eCollection 2026.
PubMed 42741696
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Amplification in Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06183476
- Acronym / sponsor ID
- 2023-1387
- Conditions
- Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Amplify-RHYTHM focuses on timed light exposure and weekly remote coaching session to optimize circadian and sleep behaviors.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Amplify-RHYTHMAmplify-RHYTHM will consist of two main components: 1) timed light exposure, 2) weekly remote coaching session. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 2 diabetes
- a history of at least moderate non-proliferative diabetic retinopathy
- would like to improve sleep
- own a smartphone compatible with fitbit.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amplify-RHYTHMAmplify-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 | Behavioural | Intervention |
Primary outcome
Sleep
Time frame: baseline and 6-week
Objective and Subjective Sleep Parameters
3 secondary outcomes
Salivary melatonin
Time frame: baseline and 6-week
Glucose levels
Time frame: baseline and 6-week
High sensitivity C-reactive protein
Time frame: baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 42741696Reutrakul S, McAnany JJ, Park JC, Cross A, Danielson KK, Van Cauter E, Hanlon EC, Law J, Pratuangtham S, Chau FY, Baron KG, Priyadarshini M, Duffecy J. Circadian rhythm amplification in diabetic retinopathy: a pilot study. Sleep Adv. 2026 Aug 20;7(3):zpag091. doi: 10.1093/sleepadvances/zpag091. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amplify-RHYTHM in people with Diabetic Retinopathy, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep (time frame: baseline and 6-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06183476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.