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.

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.

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

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.

Influence of high risk of obstructive sleep apnea on adherence to antihypertensive treatment in outpatients.

Obstructive sleep apnea (OSA) is a common cause of high blood pressure (BP). Many patients, however, have uncontrolled BP because of nonadherence to antihypertensive medication. The possibility that OSA influences adherence has not been investigated to date. The authors sought to explore the possible association between high risk of OSA and nonadherence. This study was carried out in a hypertension outpatient clinic. Adherence to medication, high risk of OSA, and sleepiness were evaluated in a cross-sectional study. These variables were identified using the eight-item Morisky, STOP-Bang, and Epworth scales, respectively. A total of 416 patients with hypertension were enrolled (32% male, aged 65±11 years). Nonadherence was identified in 71 (17%) individuals. The prevalence of high risk of OSA was 323 (78%) and of somnolence was 136 (33%). High risk of OSA was associated with nonadherence, showing a prevalence ratio (PR) of 2.6 (95% confidence interval [CI], 1.3-5.6) and retained significance after adjustment for sleepiness (PR, 2.3; 95% CI, 1.1-4.9 [P=.011]). Sleepiness was also associated with nonadherence (PR, 1.7; 95% CI, 1.1-2.6 [P=.003]). High risk of OSA and sleepiness are associated with nonadherence. These conditions, if treated, may allow for achieving better outcomes and improvement of adherence to medication.

Exercise, Occupational Activity, and Risk of Sleep Apnea: A Cross-Sectional Study.

STUDY OBJECTIVES: To investigate whether structured exercise and occupational activity are associated with obstructive sleep apnea (OSA) severity. METHODS: The International Physical Activity Questionnaire was answered by 5,453 individuals who underwent full-night polysomnography. Participants were classified as exercisers or non-exercisers and also as occupationally active or non-active. The apnea-hypopnea index (AHI), minimum oxygen saturation (SaO2min), and time with saturation below 90% (TB90%) during polysomnography were used as indicators of OSA severity. RESULTS: The sample included mostly men (59%), non-exercisers (56%), and occupationally non-active individuals (75%). Mean age (± standard deviation) was 44 ± 14 years, and mean body mass index was 29.9 ± 7.3 kg/m2. Non-exercisers had higher AHI (median 14, 25-75% interquartile range 4-34) than exercisers (8 [2-24]), lower SaO2min (83 ± 9 vs. 86 ± 8%), and longer TB90% (2 [0-18] vs. 0 [0-7] minutes), with p < 0.001 for all comparisons. AHI was higher in active (16 [6-34]) vs. non-active occupations (10 [3-27]; p < 0.001). Multinomial logistic regression with control for age, sex, overweight, obesity, and occupational activity showed that structured exercise was significantly associated with a 23% lower odds ratio for moderate OSA and 34% lower odds ratio for severe OSA. Active occupation was not associated with OSA. CONCLUSIONS: Structured physical exercise is associated with lower odds for OSA, independently of confounders. Occupational activity does not seem to replace the effects of regular exercise. Compensatory behaviors may be involved in these diverging outcomes. Our results warrant further research about the effect of occupational activity on OSA severity.