Interdisciplinary weight loss and lifestyle intervention for obstructive sleep apneathe interapnea randomized clinical trial

Resumen

Obstructive sleep apnea (OSA), characterized by recurrent sleep-state dependent upper-airway collapse with obesity as the leading attributable cause, is a major public health problem owing not only to its high and increasing prevalence — up to one billion adults globally — but also to its wide spectrum of clinical and socioeconomic consequences. Although continuous positive airway pressure (CPAP) is the first-line treatment for this condition, CPAP is a chronic day-to-day treatment, adherence rates are suboptimal, and long-term benefits beyond reduction of upper-airway occlusions remain uncertain. Conversely, weight loss through alternative or combined behavioral interventions appears to substantially improve OSA and coexisting conditions in adults with moderate-to-severe OSA. However, weight loss and behavioral approaches, although suggested, are still not a standard recommendation in existing clinical practice guidelines owing to the modest quality of evidence and methodological weaknesses found in this field of research. The main aim of this International Doctoral Thesis was to test the efficacy of an eight-week interdisciplinary weight loss and lifestyle intervention combined with usual-care (i.e., CPAP), as compared with usual-care alone, on OSA severity and OSA-related comorbidities among adults with moderate-to-severe OSA and overweight/obesity. To this end, the Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnea (INTERAPNEA) randomized, parallel-group, open-label trial was designed and conducted between April 2019 and October 2021. A total of 89 participants with CPAP-treated moderate-to-severe OSA and overweight/obesity were randomly assigned to a usual-care/control group (49 participants), or an eight-week weight loss and lifestyle intervention involving nutritional behavior change, aerobic exercise, sleep hygiene, and alcohol and tobacco cessation, combined with usual-care (40 participants). The primary outcome was the change in the number of apneas and hypopneas per hour of sleep (apnea-hypopnea index; AHI) at intervention endpoint and six months after intervention. Secondary outcomes comprised changes in other OSA sleep-related outcomes, body weight and composition, cardiometabolic risk, and health-related quality of life. Additional study outcomes included daily functioning and mood, physical fitness and dietary behavior. According to results, the weight loss and lifestyle intervention group had a clinically meaningful reduction in AHI of 51% at intervention endpoint; 15% of participants attaining complete remission of OSA, and 45% no longer requiring CPAP therapy. After six months, the reduction in AHI was 57%; the complete remission of OSA being attained by 29% of participants; 62% no longer requiring CPAP therapy. Similarly, the intervention group notably exhibited 7%, 19% and 26% reductions in body weight, fat mass and visceral adipose tissue at 6 months after intervention, respectively. Furthermore, these results were strengthened by the evidence of significant improvements in key cardiometabolic outcomes involved in the pathogenesis of cardiovascular diseases. Clinically significant improvements in daily functioning and mood, physical fitness and dietary behavior outcomes were also found in the intervention group as compared with the control group. In conclusion, this International Doctoral Thesis and thus, the INTERAPNEA trial, demonstrates that an interdisciplinary weight loss and lifestyle intervention involving adults with CPAP-treated moderate-to-severe OSA and overweight/obesity resulted in clinically meaningful and sustainable improvements not only in OSA severity and comorbidities but also in health-related quality of life, daily functioning and mood, physical fitness and dietary behavior. Given the high prevalence of OSA, its complex and reciprocal interaction with obesity, and the fact that both conditions are readily treatable through an integrated behavioral intervention, health-care providers and policy-makers should, at the very least, consider this approach as a central strategy to comprehensively address the staggering impact of OSA on the health and welfare of our society.