Abstract: Introduction: Hypertension is the leading cause of cardiovascular disease, with nocturnal blood pressure (BP) abnormalities (nocturnal hypertension and non-dipping BP) linked to heightened risk. Obstructive sleep apnea (OSA), a modifiable contributor to impaired nighttime BP regulation, commonly co-occurs with hypertension. Primary care (PC) represents a strategic setting for their integrated management. The METASLEEP study aims to develop, implement, and evaluate a novel PC-based hypertension care model incorporating OSA diagnosis, treatment, and home monitoring to improve BP control.
Objectives: To describe the rationale, design, methodology, and baseline participant characteristics of the 2024 initiation phase of the METASLEEP trial.
Material and methods: Prospective, longitudinal, real-world implementation study conducted across 10 Spanish regions (ClinicalTrials.gov NCT05986487). Adults with hypertension and no prior OSA diagnosis undergo 24-h ambulatory BP monitoring (ABPM) in PC (target n = 1523). Participants with nocturnal hypertension and/or non-dippers receive PC-led OSA diagnostic testing, treatment, and home monitoring via an under-mattress sensor. Follow-ups at 6 and 12 months evaluate changes in nighttime BP (primary) and other clinical outcomes.
Results: By end of 2024, 553 patients completed baseline ABPM. Of these, 288 (52.1%) showed nocturnal BP abnormalities: 248 (44.8%) had nocturnal hypertension and 211(38.4%) were non-dippers. Participants were middle-aged, overweight, and frequently had comorbid dyslipidemia, obesity, and diabetes. OSA prevalence was 22.6% mild, 34.1% moderate, and 35.3% severe. CPAP treatment was initiated in 79.4% of moderate-to-severe cases.
Conclusions: METASLEEP introduces a novel PC-based model integrating OSA diagnosis and management within hypertension care. Early data reveal notably high prevalence of undiagnosed OSA in hypertensive
