Effect of an Interdisciplinary Weight Loss and Lifestyle Intervention on Obstructive Sleep Apnea Severity: The INTERAPNEA Randomized Clinical Trial Carneiro Barrera, Almudena Amaro Gahete, Francisco José Guillén Riquelme, Alejandro Jurado Fasoli, Lucas Sáez Roca, Germán Martín Carrasco, Carlos Buela Casal, Gualberto Ruiz Ruiz, Jonatan This study was supported by grants FPU16/01093 (Dr Carneiro-Barrera), FPU14/04172 (Dr Amaro-Gahete), and FPU19/01609 (Mr Jurado-Fasoli) from the Spanish Ministry of Education and Vocational Training; grant SOMM17/6107/UGR (via European Regional Development Funds) from the Junta de Andalucia, Consejeria de Conocimiento, Investigacion y Universidades (Dr Ruiz); and funding from the University of GranadaLoMonaco S.L. Sleep Research Cathedra and the University of Granada Plan Propio de Investigacion 2016Excellence Actions: Unit of Excellence on Exercise and Health. IMPORTANCE Obesity is the leading cause of obstructive sleep apnea (OSA); however, the effects of weight loss and lifestyle interventions on OSA and comorbidities remain uncertain. OBJECTIVE To evaluate the effect of an interdisciplinary weight loss and lifestyle intervention on OSA and comorbidities among adults with moderate to severe OSA and overweight or obesity. DESIGN, SETTING, AND PARTICIPANTS The InterdisciplinaryWeight Loss and Lifestyle Intervention for OSA (INTERAPNEA) study was a parallel-group open-label randomized clinical trial conducted at a hospital-based referral center in Granada, Spain, from April 1, 2019, to October 23, 2020. The study enrolled 89 Spanish men aged 18 to 65 years with moderate to severe OSA and a body mass index (calculated as weight in kilograms divided by height in meters squared) of 25 or greater who were receiving continuous positive airway pressure (CPAP) therapy. The sole inclusion of men was based on the higher incidence and prevalence of OSA in this population, the differences in OSA phenotypes between men and women, and the known effectiveness of weight loss interventions among men vs women. INTERVENTIONS Participants were randomized to receive usual care (CPAP therapy) or an 8-week weight loss and lifestyle intervention involving nutritional behavior change, aerobic exercise, sleep hygiene, and alcohol and tobacco cessation combined with usual care. MAIN OUTCOMES AND MEASURES The primary end point was the change in the apnea-hypopnea index (AHI) from baseline to the intervention end point (8 weeks) and 6 months after intervention. Secondary end points comprised changes in other OSA sleep-related outcomes, body weight and composition, cardiometabolic risk, and health-related quality of life. RESULTS Among 89 men (mean [SD] age, 54.1 [8.0] years; all of Spanish ethnicity; mean [SD] AHI, 41.3 [22.2] events/h), 49 were randomized to the control group and 40 were randomized to the intervention group. The intervention group had a greater decrease in AHI (51% reduction; change, –21.2 events/h; 95%CI, –25.4 to –16.9 events/h) than the control group (change, 2.5 events/h; 95% CI, –2.0 to 6.9 events/h) at the intervention end point, with a mean between-group difference of –23.6 events/h (95%CI, –28.7 to –18.5 events/h). At 6 months after intervention, the reduction in AHI was 57%in the intervention group, with a mean between-group difference of –23.8 events/h (95% CI, –28.3 to –19.3 events/h). In the intervention group, 18 of 40 participants (45.0%) no longer required CPAP therapy at the intervention end point, and 6 of 40 participants (15.0%) attained complete OSA remission. At 6 months after intervention, 21 of 34 participants (61.8%) no longer required CPAP therapy, and complete remission of OSA was attained by 10 of 34 participants (29.4%). In the intervention vs control group, greater improvements in body weight (change, –7.1 kg [95%CI, −8.6 to −5.5 kg] vs −0.3 kg [95%CI, −1.9 to 1.4 kg]) and composition (eg, change in fat mass, −2.9 kg [95%CI, −4.5 to −1.3 kg] vs 1.4 kg [95%CI, −0.3 to 3.1 kg]), cardiometabolic risk (eg, change in blood pressure, −6.5mmHg [95%CI, −10.3 to −2.6mmHg] vs 2.2mmHg [95%CI, −2.1 to 6.6mm Hg]), and health-related quality of life (eg, change in Sleep Apnea Quality of Life Index, 0.8 points [95%CI, 0.5-1.1 points] vs 0.1 points [95%CI, −0.3 to 0.4 points]) were also found at the intervention end point. CONCLUSIONS AND RELEVANCE In this study, an interdisciplinary weight loss and lifestyle intervention involving Spanish men with moderate to severe OSA and had overweight or obesity and were receiving CPAP therapy resulted in clinically meaningful and sustainable improvements in OSA severity and comorbidities as well as health-related quality of life. This approach may therefore be considered as a central strategy to address the substantial impact of this increasingly common sleepdisordered breathing condition. 2022-05-09T09:50:25Z 2022-05-09T09:50:25Z 2022-04-22 info:eu-repo/semantics/article Carneiro-Barrera A... [et al.]. Effect of an Interdisciplinary Weight Loss and Lifestyle Intervention on Obstructive Sleep Apnea Severity: The INTERAPNEA Randomized Clinical Trial. JAMA Netw Open. 2022;5(4):e228212. doi:[10.1001/jamanetworkopen.2022.8212] http://hdl.handle.net/10481/74750 10.1001/jamanetworkopen.2022.8212 eng http://creativecommons.org/licenses/by/3.0/es/ info:eu-repo/semantics/openAccess Atribución 3.0 España American Medical Association