Amplify-RHYTHM for Diabetic Retinopathy

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Illinois at Chicago

Must not be taking: Melatonin, Antipsychotics, Antidepressants, Sedatives

Disqualifiers: Illicit drug use, Stroke, Dementia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial requires that you stop using melatonin, antipsychotics, and more than one antidepressant. If you are on one antidepressant, the dose must be stable for 6 weeks before joining the trial.

What data supports the effectiveness of the treatment Amplify-RHYTHM for diabetic retinopathy?

Research on subthreshold micropulse diode laser photocoagulation, a similar treatment, shows it can be effective and safe for diabetic macular edema, which is related to diabetic retinopathy. This suggests that treatments like Amplify-RHYTHM might also be beneficial for diabetic retinopathy. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I want to improve my sleep.

I have type 2 diabetes.

I have had moderate diabetic eye disease in the past.

Exclusion Criteria

I need oxygen for my chronic lung condition.

No health insurance coverage

I have severe liver disease, like cirrhosis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week comprehensive circadian optimization intervention called Amplify-RHYTHM, which includes timed light exposure and weekly remote coaching sessions.

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on sleep parameters, salivary melatonin and cortisol levels, and glucose monitoring.

4 weeks

Treatment Details

Interventions

• Amplify-RHYTHM (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Illinois at Chicago Chicago, IL

Who Is Running the Clinical Trial?

University of Illinois at Chicago Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Subthreshold micropulse diode laser photocoagulation for diabetic macular edema in Japanese patients. [2022] To assess the efficacy and safety of subthreshold micropulse diode laser photocoagulation for diabetic macular edema (ME).

2. England pubmed.ncbi.nlm.nih.gov

The National Diabetic Retinopathy Laser Treatment Audit. I. Maculopathy. [2016] The National Diabetic Retinopathy Laser Treatment Audit is a prospective survey of laser treatment for diabetic retinopathy throughout the United Kingdom. This paper describes the methodology of the study and presents data on 546 patients who were undergoing their first photocoagulation treatment for diabetic maculopathy (without proliferative retinopathy) during a 2 month period in 1995. Validation of the level of participation, patient demographic features, sources of referral, the level of systematic screening and waiting times are described. Maculopathy was detected as a result of systematic screening in 65.2%, whilst 12.3% of cases presented symptomatically. The percentage of cases treated within 8 weeks of listing was 83.1%, whilst 7% waited for more than 12 weeks for their laser treatment. The retinopathy features and the type of treatment given are also described. The maculopathy was said to be predominantly exudative in nature in 69.8% of cases, and 96.2% of these eyes were treated with focal macular laser. The maculopathy was said to be diffusely oedematous in nature in 8.6% of cases, and 78.7% of these eyes were treated with grid macular laser.

3. Japan pubmed.ncbi.nlm.nih.gov

Comparison of two-year treatment outcomes between subthreshold micropulse (577 nm) laser and aflibercept for diabetic macular edema. [2021] To compare two-year treatment outcomes of subthreshold micropulse (577 nm) laser and aflibercept for diabetic macular edema (DME).

4. United States pubmed.ncbi.nlm.nih.gov

DEXAMETHASONE IMPLANT FOR DIABETIC MACULAR EDEMA IN NAIVE COMPARED WITH REFRACTORY EYES: The International Retina Group Real-Life 24-Month Multicenter Study. The IRGREL-DEX Study. [2020] To investigate efficacy and safety of repeated dexamethasone (DEX) implants over 24 months, in diabetic macular edema (DME) eyes that were treatment naive compared with eyes refractory to anti-vascular endothelial growth factor treatment, in a real-life environment.

5. United States pubmed.ncbi.nlm.nih.gov

PHOTOCOAGULATION VERSUS RANIBIZUMAB FOR PROLIFERATIVE DIABETIC RETINOPATHY: Should Baseline Characteristics Affect Choice of Treatment? [2020] Among eyes with proliferative diabetic retinopathy, identify whether baseline characteristics impact the benefit of ranibizumab over panretinal photocoagulation (PRP) in DRCR.net Protocol S.