| Abstract |
Introduction: OSAHS is a common sleep disorder associated with increased cardiovascular disease morbidity and mortality. Obesity constitutes one of the major risk factors for OSAHS progression, as it contributes to increased in particular, cardiovascular, morbidity and mortality. OSAHS should be approached as a chronic disease that requires pathophysiological and clinical phenotyping, objective diagnostic testing and individualized treatment plan with Positive Airway Pressure (PAP) as the first-line symptomatic treatment of choice. However, lifestyle interventions have also emerged as complementary therapeutic choices.
Aim: The aim of our study was to explore the role of a 3 and 6 month diet intervention on treatment adherence in patients with OSAHS. Specifically, we will evaluate the effects of a combination of PAP and weight-loss Mediterranean diet intervention on improving PAP adherence (hours of device use), Body mass index (ΒΜΗ), daytime symptoms, mainly sleepiness and arterial blood pressure measurements over the effect of standard care alone.
Methods: We designed a parallel, randomized, controlled, clinical trial. Eligible participants were adult, overweight and obese men and women, diagnosed with moderate-to-severe OSAHS [apnea-hypopnea index (AHI)≥15 events/h] through an attended overnight polysomnography. Participants, after written informed consent, were blindly randomized to a standard care group (SCG, n=25) and a Mediterranean diet group (MDG, n=24). All two study groups were prescribed with PAP. The SCG
Public Health-Primary Health Care-Health Services
School of Medicine–University of Crete
9
received oral healthy lifestyle advice and counselling on physical activity and sleep habits, while the MDG was additionally subjected to a 6-month diet intervention aiming at improving diet quality, weight loss and increasing adherence to the Mediterranean diet. Parameters including PAP adherence, BMI, daytime sleepiness, evaluated by Epworth Sleepiness Scale (ESS) and arterial blood pressure measurements were evaluated pre- and post-intervention. Ethical approval was provided by the Research Ethics Committee at the University of Crete (REC-UOC).
Results: No statistically significant changes were noted between the 2 groups in clinical characteristics or sleep study parameters. As this is an ongoing study, 3 month follow up data are presented. All patients started PAP treatment. Post intervention PAP use was higher in the MDG group compared to the SCG (6.5 ± 3 vs 5.7 ± 2, p=0.2), although the difference was not statistically significant. However, further analysis showed that diet intervention was the most significant predictive factor for improved PAP adherence (OR = 19.910, 95% CI = 1.349-293.919, p=0.02). Regarding BMI, an increase was noted in the SCG group, whereas a decrease (improvement) in the MDG, although not statistically significant (p=0.31). Blood pressure measurements were not statistically or significantly changed after the 3 month follow period in both groups. Despite the statistically significant decrease in ESS noted in both groups, no group had a significant predominance in this improvement (p=0.29).
Conclusions: A dietary intervention on top of standard care leads to greater improvements in PAP adherence compared to standard care alone. We assume that the effects of this intervention on BMI, arterial blood pressure measurements and daytime sleepiness will be statistically significant after the end of the study.
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