Impact of Sleep-disordered Breathing Management in Primary Care on Systemic Hypertension Control: Protocol for the...

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.

To describe the rationale, design, methodology, and baseline participant characteristics of the 2024 initiation phase of the METASLEEP trial.

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.

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.

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 patients.