Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece.
Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece.
Clin Nutr. 2021 Mar;40(3):850-859. doi: 10.1016/j.clnu.2020.08.037. Epub 2020 Sep 6.
BACKGROUND & AIMS: Although continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea (OSA), lifestyle interventions have also emerged as complementary therapeutic choices. We aimed to explore whether the addition of a weight-loss Mediterranean diet/lifestyle intervention to OSA standard care, i.e. CPAP prescription and brief written healthy lifestyle advice, has an incremental effect on improving OSA severity, over the effect of standard care alone.
We designed a parallel, randomized, controlled, superiority clinical trial. Eligible participants were adult, overweight men and women, diagnosed with moderate-to-severe OSA [apnea-hypopnea index (AHI)≥ 15 events/h] through an attended overnight polysomnography. Participants were blindly randomized to a standard care group (SCG, n = 65), a Mediterranean diet group (MDG, n = 62) or a Mediterranean lifestyle group (MLG, n = 60). All three study groups were prescribed with CPAP. The SCG additionally received written healthy lifestyle advice, while intervention arms were subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet. The MLG also received counselling on physical activity and sleep habits. Polysomnographic data and OSA symptoms were evaluated pre- and post-intervention.
A total of 187 OSA patients were recruited. Seven patients were excluded post-randomization and 53/180 (29%) were lost to follow-up. No harms from the interventions applied were reported. According to intention-to-treat analysis (n = 180), mean (95% confidence interval) AHI change was -4.2 (-7.4, -1.0) for the SCG, -24.7 (-30.4, -19.1) for the MDG and -27.3 (-33.9, -20.6) for the MLG. Post-intervention age-, sex-, baseline- and CPAP use-adjusted AHI was significantly lower in the MDG and the MLG compared to the SCG (mean difference: -18.0, and -21.2, respectively, both P < 0.001), and the differences remained significant after further adjustment for body-weight change (P = 0.004 and 0.008, respectively). Other respiratory event indices, daytime sleepiness and insomnia were also significantly lower in both intervention arms compared to the SCG (all P < 0.05). The MLG only presented higher percent rapid-eye-movement sleep and lower daytime sleepiness compared to the MDG (both P < 0.05). Results were similar in the per-protocol analysis (n = 127).
A dietary/lifestyle intervention on top of standard care leads to greater improvements in OSA severity and symptomatology compared to standard care alone. Benefits are evident regardless of CPAP use and weight loss.
Clinicaltrials.gov NCT02515357, https://clinicaltrials.gov/ct2/show/NCT02515357.
尽管持续气道正压通气（CPAP）是阻塞性睡眠呼吸暂停（OSA）的一线治疗方法，但生活方式干预也已成为补充治疗选择。我们旨在探讨在 OSA 标准治疗（即 CPAP 处方和简短的书面健康生活方式建议）的基础上，添加减肥地中海饮食/生活方式干预是否会对改善 OSA 严重程度产生额外影响，而不是仅依靠标准治疗。
我们设计了一项平行、随机、对照、优势临床试验。符合条件的参与者为成年超重男性和女性，通过 attended overnight polysomnography 诊断为中重度 OSA[呼吸暂停-低通气指数（AHI）≥ 15 次/小时]。参与者被盲法随机分配至标准治疗组（SCG，n=65）、地中海饮食组（MDG，n=62）或地中海生活方式组（MLG，n=60）。所有三组均接受 CPAP 治疗。SCG 还额外接受了书面健康生活方式建议，而干预组则接受了为期 6 个月的行为干预，旨在减轻体重并增加对地中海饮食的依从性。MLG 还接受了关于身体活动和睡眠习惯的咨询。在干预前后评估了多导睡眠图数据和 OSA 症状。
共招募了 187 名 OSA 患者。7 名患者在随机分组后被排除，53/180（29%）失访。未报告干预措施应用的任何危害。根据意向治疗分析（n=180），SCG 的平均（95%置信区间）AHI 变化为-4.2（-7.4，-1.0），MDG 为-24.7（-30.4，-19.1），MLG 为-27.3（-33.9，-20.6）。与 SCG 相比，MDG 和 MLG 干预后的年龄、性别、基线和 CPAP 使用调整后的 AHI 明显更低（平均差异：-18.0 和-21.2，均 P<0.001），并且在进一步调整体重变化后差异仍然显著（P=0.004 和 0.008，分别）。在两组干预组中，其他呼吸事件指数、日间嗜睡和失眠也明显低于 SCG（均 P<0.05）。与 MDG 相比，MLG 仅表现出更高的快速眼动睡眠百分比和更低的日间嗜睡（均 P<0.05）。在符合方案分析（n=127）中，结果相似。
与单独的标准治疗相比，在标准治疗基础上进行饮食/生活方式干预可显著改善 OSA 严重程度和症状。无论 CPAP 使用和体重减轻情况如何，均能获益。
Clinicaltrials.gov NCT02515357，https://clinicaltrials.gov/ct2/show/NCT02515357。
