Dataset Information

The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic.

ABSTRACT:

Objectives

To describe the MORPHEOS (Morbidity in patients with uncontrolled HTN and OSA) trial, and describe the challenges imposed by the COVID-19 pandemic.

Methods

MORPHEOS is a multicenter (n=6) randomized controlled trial designed to evaluate the blood pressure (BP) lowering effects of treatment with continuous positive airway pressure (CPAP) or placebo (nasal strips) for 6 months in adult patients with uncontrolled hypertension (HTN) and moderate-to-severe obstructive sleep apnea (OSA). Patients using at least one antihypertensive medication were included. Uncontrolled HTN was confirmed by at least one abnormal parameter in the 24-hour ABPM and ≥80% medication adherence evaluated by pill counting after the run-in period. OSA was defined by an apnea-hypopnea index ≥15 events/hours. The co-primary endpoints are brachial BP (office and ambulatory BP monitoring, ABPM) and central BP. Secondary outcomes include hypertension-mediated organ damage (HMOD) to heart, aorta, eye, and kidney. We pre-specified several sub-studies from this investigation. Visits occur once a week in the first month and once a month thereafter. The programmed sample size was 176 patients but the pandemic prevented this final target. A post-hoc power analysis will be calculated from the final sample. ClinicalTrials.gov: NCT02270658.

Results

The first 100 patients are predominantly males (n=69), age: 52±10 years, body mass index: 32.7±3.9 kg/m2 with frequent co-morbidities.

Conclusions

The MORPHEOS trial has a unique study design including a run-in period; pill counting, and detailed analysis of hypertension-mediated organ damage in patients with uncontrolled HTN that will allow clarification of the impact of OSA treatment with CPAP.

SUBMITTER: Cruz FCSG

PROVIDER: S-EPMC8382149 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background Studies have shown that a significant percentage of patients with obstructive sleep apnea (OSA) do not tolerate continuous positive airway pressure (CPAP) therapy and long-term use may be as low as 30%. Given the lower levels of symptoms and health-related risks, patients with mild sleep apnea may be at even higher risk for non-adherence to long term CPAP. The purpose of our study was to investigate the prevalence and associations of long-term CPAP adherence in first time users with mild sleep apnea diagnosed by home sleep apnea testing (HSAT). Methods We identified all the patients who were diagnosed with mild sleep apnea (5 = < AHI < 15) by home sleep apnea testing from 01/2013 to 06/2019 at a large, combined community and hospital-based sleep practice. Only first time CPAP users were included. Compliance was defined as CPAP usage ≥ 4 h per night on ≥ 70% of nights over 30 consecutive days. We defined long term adherence as compliance on the 12th month following CPAP set up. Patient demographics, comorbidities, and CPAP compliance at 1st, 3rd, 6th, 9th and 12th month after therapy initiation were collected. We compared and identified the factors that had significant difference (P < 0.1) between compliant and non-compliant groups at the 12th month. Results 222 patients were included in the analysis. 57 (25.7%) patients were adherent with long term CPAP treatment. The following factors were associated with a greater likelihood for long-term CPAP adherence: older age, lower body mass index (BMI), presence of a bed partner, non-smoker, presence of Diabetes Mellitus (DM), presence of Heart Failure (CHF), lack of depression, and compliance at 1st, 3rd, 6th and 9th month. Conclusions Long term CPAP compliance in mild sleep apnea patients is low. Long term adherence to CPAP can be predicted based on CPAP adherence during the first three months. Supplementary Information The online version contains supplementary material available at 10.1186/s12890-023-02612-3.

Project description:Background: Obstructive sleep apnea syndrome (OSAS) is an independent risk factor for cardiovascular morbidity and mortality, and it has a detrimental effect on renal function. Obesity is the major risk factor for OSAS, and represents a risk factor for chronic kidney disease. Continuous positive airway pressure (CPAP) is the suggested therapy for moderate-to-severe OSAS. We designed this study to evaluate the effect of CPAP on estimated glomerular filtration rate (e-GFR) in a cohort of obese patients with moderate-to-severe OSAS and normal renal function. Methods: We enrolled 198 obese subjects, divided into two groups (OSAS+ and OSAS-), on the basis of cardiorespiratory monitoring; mild OSAS patients (n = 33) were excluded from the study, thus the analyses were conducted on 165 patients. Comparisons between groups were made by Student t-test or χ2 test as appropriate. Linear regression analyses were used to assess the relationship between baseline e-GFR and different covariates and, in the OSAS+ group, between Δe-GFR and different covariates. A multivariate regression analysis was performed to determinate the independent predictor of the Δe-GFR. Results: OSAS+ subjects showed significantly increased values of systolic blood pressure, HOMA, pulse wave velocity, high-sensitivity C reactive protein and uric acid compared with OSAS- group. OSAS+ group showed significantly lower values of e-GFR and increased values of microalbuminuria. At linear regression analysis e-GFR resulted significantly and inversely related to AHI in the whole study population and in the two groups. After 6 months of CPAP therapy, OSAS+ subjects showed an improvement in respiratory parameters, as well as a significant increase in e-GFR values (104.2 + 19.0 vs. 84.0 + 13.1 ml/min/1.73 m2, P < 0.0001). At multiple regression analysis, Δ apnea/hypopnea index (AHIa) resulted the main independent predictor of Δe-GFR explaining 22% of its variation. Conclusions: Obese OSAS patients show significantly lower values of e-GFR, even if in the normal range, compared with obese non-OSAS subjects. After 6 months of CPAP, e-GFR significantly improved (+20 ml/min/1.73 m2) and ΔAHIa resulted the most important independent predictor of Δe-GFR.