NCT02874313

CPAP Effect on the Progression of Diabetic Retinopathy in Patients With Sleep Apnea

Effect of Continuous Positive Airway Pressure on the Progression of Vascular Retinal Disease in Patients With Sleep Apnea and Non-proliferative Diabetic Retinopathy. A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Objectives: Main objective: To compare the percentage of patients with new microaneurysm or hard exudates after 12 months between the CPAP group and the control group. Secondary objectives: To compare the central macula volume, ganglion cell layer thickness and central fovea thickness at baseline and 12, 24 and 52 weeks after randomization between the two study groups; to compare the percentage of patients who have an improvement loss of visual acuity (more than or equal to 15 letters in patients with macular edema and more than or equal to five letters in patients without macular edema) among the baseline visit and the weeks 12, 24 and 52 between the two study groups; to compare the percentage of patients who reach a higher level of diabetic retinopathy at 54 weeks between the two study groups; to compare the resolution time of central macula thickness from the randomization between the two study groups; to compare the glycated hemoglobin at baseline and 12, 24 and 52 weeks after randomization between the two study groups; and to compare the serum levels of inflammatory cytokines, oxidative stress biomarkers, sympathetic tone, and intake regulator hormones at baseline and 12 and 52 weeks after randomization between the two study groups. Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional treatment-controlled trial of 12 months of duration. Subjects will randomize to conventional dietary and pharmacological treatment or conventional dietary and pharmacological treatment plus continuous positive airway pressure (CPAP). Study subjects: Subjects 35 to 75 years with type 2 diabetes and a clinical diagnosis of mild diabetic retinopathy (with or without macular edema), better visual acuity from 20/40 to 20/320 letters and refraction with a spherical equivalent less than ± 5 diopter. Efficacy variables: Thickness of the central sub-field, central subfield volume, ganglion cell layer thickness, and presence of clinical or subclinical macular edema, serous retinal or retinal pigment epithelium detachment, intraretinal cysts or haemorrhages assessed by optical coherence tomography; presence of cotton exudates, microhemorrhages, microaneurysms, , microvascular retinal abnormalities, or a vein/artery ratio \> 2/1 in examination of ocular fundus/retinography; better corrected visual acuity; glycosylated hemoglobin (HbA1c); fasting glucose and insulin; homeostatic model assessment (HOMA) and QUICKI indices; lipid profile, troponin I, proBNP, homocysteine and C-reactive protein; systemic biomarkers of inflammation, oxidative stress, endothelial damage, sympathetic activity and appetite-regulating hormones and clinical questionnaires: short form (SF)-12, visual function questionnaire (VFQ25) and iPAQ.

Conditions

• Diabetic Retinopathy
• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Continuous positive airway pressure	Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed).
DRUG	Pharmacological treatment	Conventional pharmacological treatment with oral antidiabetic drugs or insulin
OTHER	Conventional anti-diabetic diet recommendations

Timeline

• Start date: 2016-08-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2016-08-22
• Last updated: 2021-05-11

Locations

1 site across 1 country: Spain