Cardiovascular and metabolic effects of a mandibular advancement device and continuous positive airway pressure in moderate obstructive sleep apnea: a randomized controlled trial

STUDY OBJECTIVES: It has been suggested that treatment for obstructive sleep apnea (OSA) reduces cardiovascular risk. So far, knowledge is limited about the difference in the reduction of this risk between mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy. The aim of this study was to compare the cardiovascular effects of MAD versus CPAP therapy in patients with moderate OSA.

METHODS: Patients with an apnea-hypopnea index (AHI) of 15-30 events/h were randomized to either MAD or CPAP therapy. At baseline and after 12-months follow-up, 24-hour ambulant blood pressure measurements (ABPM) and laboratory measurements were performed. ABPM consisted of 24-hour, daytime and night-time systolic (SBP) and diastolic blood pressure (DBP), and heart rate (HR) measurements. Laboratory measurements consisted of serum lipid values, creatinine, high-sensitivity c-reactive protein, plasma glucose, hemoglobin A1c (HbA1c), proinflammatory cytokines, soluble receptor for advanced glycation end products (sRAGE), chemokines and adhesion molecules.

RESULTS: Of the 85 randomized patients with moderate OSA, data were available for 54 patients (n=24 MAD, n=30 CPAP) at 12-month follow-up and showed that AHI significantly decreased with either therapy. In the MAD group, sRAGE and HbA1c were significantly higher after 12 months follow-up compared to baseline. No significant changes were found between MAD and CPAP treatment for all outcomes.

CONCLUSIONS: Treatment of patients with moderate OSA with either MAD or CPAP therapy had no profound effects on major cardiovascular risk factors after 12-months.

CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: MRA Therapy Versus CPAP Therapy in Moderate OSAS; Identifier: NCT01588275; URL: https://clinicaltrials.gov/ct2/show/NCT01588275.