Impact of a multidisciplinary sleep apnea management group clinic on positive airway pressure adherence and patient-reported outcomes: a randomized controlled trial.

IF 2 4区 医学 Q3 CLINICAL NEUROLOGY
Sepideh Khazaie, Reena Mehra, Raman Bhambra, Douglas E Moul, Nancy Foldvary-Schaefer, Robon Vanek, James Bena, Shannon Morrison, Harneet K Walia
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Abstract

Introduction: Positive airway pressure (PAP) is the mainstay of treatment for obstructive sleep apnea (OSA). However, suboptimal adherence significantly limits its effectiveness. This study examined the impact of a Sleep Apnea Management (SAM) clinic-an innovative, interactive group intervention providing interpersonal support, education, and resources-on PAP adherence and patient-reported outcomes (PROs) compared to usual care.

Methods: Participants with OSA who were newly prescribed PAP therapy and demonstrated suboptimal adherence (defined using CMS criteria during the first two weeks) were randomized to the SAM clinic (n = 26) or usual care (n = 30) from April 2019 to November 2022 (NCT-03835702). The primary outcome was the change in average daily PAP usage. Secondary outcomes included changes in the Epworth Sleepiness Scale (ESS), Patient Health Questionnaire-9 (PHQ-9), and PROMIS scales from baseline to 1 and 3 months. Baseline-adjusted mixed-effects linear and logistic models estimated differences between and within groups.

Results: Fifty-six participants were enrolled with a mean age of 55 years, 57% female, 63% Caucasian, median AHI of 22.8 (IQR: 9.3,39.6), and median baseline PAP usage of 172 min. After 3 months, the mean (95% CI) SAM clinic daily PAP use was 193 (139, 247) minutes vs usual care at 148 (110, 185) minutes with a mean difference of 46(-8, 99) minutes per day (p = 0.093). Within each group, a mean daily difference of 11(-36,57) minutes (p = 0.65) in SAM clinic and -32(-75,12) (p = 0.15) in the usual care was observed. No significant differences were observed in PROs between SAM and usual care. Within each group, ESS change was -0.7(-2.5,1.2) (p = 0.48) in SAM clinic and -2.5(-4.2, -0.83) (p = .004) in usual care. Significant decrease was noted in PHQ-9 within both SAM clinic at-2.2(-3.9, -0.4) (p = 0.019) and in usual care at -2.3(-4.0, -0.7) (p = 0.006). Improvement in PROMIS sleep-related impairment was noted within both groups: SAM clinic at -3.0(-6.2,0.1) (p = 0.059) and usual care group at -3.5(-6.4, -0.60) (p = 0.019). Similar changes in PAP adherence and PROS were seen at the 1-month follow-up.

Conclusion: The SAM clinic demonstrated trends toward improved PAP adherence and PROs compared to usual care, though differences were not statistically significant, likely reflecting the study's small sample size and other methodological constraints, larger, adequately powered studies are needed to confirm these findings and further explore the impact of SAM clinics on PAP adherence and patient outcomes.

Abstract Image

多学科睡眠呼吸暂停管理组临床对气道正压依从性和患者报告结果的影响:一项随机对照试验。
导语:气道正压通气(PAP)是治疗阻塞性睡眠呼吸暂停(OSA)的主要方法。然而,次优依从性显著限制了其有效性。本研究考察了睡眠呼吸暂停管理(SAM)诊所——一种提供人际支持、教育和资源的创新、互动式小组干预——与常规护理相比,对PAP依从性和患者报告的结果(PROs)的影响。方法:2019年4月至2022年11月(NCT-03835702),新开PAP治疗并表现出次优依从性(在前两周使用CMS标准定义)的OSA患者随机分配到SAM诊所(n = 26)或常规护理(n = 30)。主要结果是平均每日PAP使用量的变化。次要结局包括Epworth嗜睡量表(ESS)、患者健康问卷-9 (PHQ-9)和PROMIS量表从基线到1个月和3个月的变化。基线调整后的混合效应线性和逻辑模型估计了组间和组内的差异。结果:56名参与者入组,平均年龄为55岁,57%为女性,63%为高加索人,中位AHI为22.8 (IQR: 9.3,39.6),中位基线PAP使用时间为172分钟。3个月后,SAM临床每日PAP使用平均(95% CI)为193(139,247)分钟,而常规护理为148(11,185)分钟,平均差异为46(- 8,99)分钟/天(p = 0.093)。在每组中,SAM诊所的平均日差为11(-36,57)分钟(p = 0.65),常规护理的平均日差为-32(-75,12)分钟(p = 0.15)。SAM与常规护理在PROs方面无显著差异。各组内,SAM临床ESS变化为-0.7(-2.5,1.2)(p = 0.48),常规护理ESS变化为-2.5(-4.2,-0.83)(p = 0.004)。在SAM诊所,PHQ-9显著下降-2.2(-3.9,-0.4)(p = 0.019),在常规护理中,PHQ-9下降-2.3(-4.0,-0.7)(p = 0.006)。两组的PROMIS睡眠相关障碍均有改善:SAM临床评分-3.0(-6.2,0.1)(p = 0.059),常规护理组评分-3.5(-6.4,-0.60)(p = 0.019)。在1个月的随访中,PAP依从性和PROS也出现了类似的变化。结论:与常规护理相比,SAM诊所显示出改善PAP依从性和PROs的趋势,尽管差异在统计上不显着,可能反映了研究的小样本量和其他方法学限制,需要更大,足够有力的研究来证实这些发现,并进一步探索SAM诊所对PAP依从性和患者预后的影响。
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来源期刊
Sleep and Breathing
Sleep and Breathing 医学-呼吸系统
CiteScore
5.20
自引率
4.00%
发文量
222
审稿时长
3-8 weeks
期刊介绍: The journal Sleep and Breathing aims to reflect the state of the art in the international science and practice of sleep medicine. The journal is based on the recognition that management of sleep disorders requires a multi-disciplinary approach and diverse perspectives. The initial focus of Sleep and Breathing is on timely and original studies that collect, intervene, or otherwise inform all clinicians and scientists in medicine, dentistry and oral surgery, otolaryngology, and epidemiology on the management of the upper airway during sleep. Furthermore, Sleep and Breathing endeavors to bring readers cutting edge information about all evolving aspects of common sleep disorders or disruptions, such as insomnia and shift work. The journal includes not only patient studies, but also studies that emphasize the principles of physiology and pathophysiology or illustrate potentially novel approaches to diagnosis and treatment. In addition, the journal features articles that describe patient-oriented and cost-benefit health outcomes research. Thus, with peer review by an international Editorial Board and prompt English-language publication, Sleep and Breathing provides rapid dissemination of clinical and clinically related scientific information. But it also does more: it is dedicated to making the most important developments in sleep disordered breathing easily accessible to clinicians who are treating sleep apnea by presenting well-chosen, well-written, and highly organized information that is useful for patient care.
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