Thornton Christina S, Povitz Marcus, Tsai Willis H, Loewen Andrea H, Ip-Buting Ada, Kendzerska Tetyana, Flemons W Ward, Fraser Kristin L, Hanly Patrick J, Pendharkar Sachin R
Dept of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Sleep Centre, Foothills Medical Centre, University of Calgary, Calgary, Canada.
ERJ Open Res. 2022 Jun 20;8(2). doi: 10.1183/23120541.00068-2022. eCollection 2022 Apr.
Obstructive sleep apnoea (OSA) is a common chronic condition that is associated with significant morbidity and economic cost. Prolonged wait times are increasingly being recognised as a barrier to diagnosis and treatment of many chronic diseases; however, no study to date has prospectively evaluated the impact of wait times on health outcomes in OSA.
The purpose of this study is to determine whether treatment outcomes for individuals with OSA differ between patients managed using an expedited standard pathway.
A pragmatic randomised controlled trial design will be used with a target sample size of 200 adults. Participants with clinically significant uncomplicated OSA will be recruited through referrals to a large tertiary care sleep centre (Calgary, AB, Canada) and randomised to either early management (within 1 month) or usual care (∼6 months) with a 1:1 allocation using a concealed computer-generated randomisation sequence. The primary outcome will be adherence to positive airway pressure (PAP) therapy at 3 months after treatment initiation. Secondary outcomes will include change in sleepiness, quality of life, patient satisfaction, and patient engagement with therapy from baseline to 3 months after PAP initiation, measured using validated questionnaires and qualitative methods.
This study will determine whether expedited care for OSA leads to differences in PAP adherence and/or patient-reported outcomes. More broadly, the findings of this study may improve the understanding of how wait time reductions impact health outcomes for other chronic diseases.
阻塞性睡眠呼吸暂停（OSA）是一种常见的慢性病，与严重的发病率和经济成本相关。等待时间过长日益被视为许多慢性病诊断和治疗的障碍；然而，迄今为止尚无研究前瞻性评估等待时间对OSA健康结局的影响。
本研究旨在确定阻塞性睡眠呼吸暂停患者的治疗结局在采用快速标准治疗途径管理的患者之间是否存在差异。
将采用实用随机对照试验设计，目标样本量为200名成年人。具有临床显著意义的非复杂性OSA参与者将通过转介至一家大型三级护理睡眠中心（加拿大艾伯塔省卡尔加里）进行招募，并使用计算机生成的隐蔽随机序列以1:1的比例随机分配至早期治疗组（1个月内）或常规治疗组（约6个月）。主要结局将是治疗开始后3个月时对持续气道正压通气（PAP）治疗的依从性。次要结局将包括从基线到PAP治疗开始后3个月的嗜睡程度变化、生活质量、患者满意度以及患者对治疗的参与度，使用经过验证的问卷和定性方法进行测量。
本研究将确定OSA的快速治疗是否会导致PAP依从性和/或患者报告结局的差异。更广泛地说，本研究的结果可能会增进对缩短等待时间如何影响其他慢性病健康结局的理解。
