Rationale and study protocol for We-PAP: a randomized pilot/feasibility trial of a couples-based intervention to promote PAP adherence and sleep health compared to an educational control.
Rationale and study protocol for We-PAP: a randomized pilot/feasibility trial of a couples-based intervention to promote PAP adherence and sleep health compared to an educational control.
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DOI：
10.1186/s40814-022-01089-x
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发表时间：
2022-08-06
影响因子：
1.7
通讯作者：
Troxel, Wendy
中科院分区：
文献类型：
--
作者：
Baron, Kelly Glazer;Gilles, Allyson;Sundar, Krishna M.;Baucom, Brian R. W.;Duff, Kevin;Troxel, Wendy
关键词：
阻塞性睡眠呼吸暂停（OSA）是一种严重的健康状况，影响约30-50%的老年人，并导致心脏代谢紊乱和痴呆症的风险。尽管伴侣在寻求治疗和坚持气道正压通气（PAP）方面的作用得到了很好的证明，但OSA的治疗几乎完全集中在患者身上，目前的OSA治疗并没有解决共存的睡眠问题，如在OSA患者及其伴侣中普遍存在的失眠。因此，本研究的目的是开发和测试一种新的基于夫妇的睡眠健康干预，以促进对PAP的坚持，改善夫妇的睡眠健康。我们正在进行一项双臂，平行组，单盲，随机对照的试点/可行性试验，以比较我们的新夫妇为基础的睡眠健康干预（We-PAP）的信息控制组（IC）。We-PAP基于一个transdiagnosis模型，并使用一种二元方法，包括增加有效的合作伙伴支持，沟通技巧和夫妇层面的目标设定。We-PAP包括3个疗程，并通过每周一次的远程保健提供。IC包括标准化的患者教育材料。两组都接受了医疗团队的常规随访。该研究包括治疗前、干预后（开始PAP并完成We-PAP疗程或IC后约1个月）和开始PAP后3个月的评估。我们的主要成果是可行性和可接受性评级。次要结局包括比较We-PAP与IC的PAP依从性、睡眠质量（自我报告和客观）和认知测量。We-PAP是第一个针对OSA患者及其伴侣的基于夫妇的跨诊断睡眠健康干预。本研究的结果将用于为后续完全把握度临床试验的设计提供信息。如果成功，这种干预可以显着推进目前的临床实践，更全面地治疗老年人的OSA和睡眠健康。此外，这种干预可能有助于改善其他患有多种睡眠和其他健康问题的老龄化人群的睡眠，包括慢性疾病患者或有阿尔茨海默病风险的患者及其护理人员。NCT 04759157。报名时间：2021年2月8日。试验登记记录的URL。
Obstructive sleep apnea (OSA) is a serious health condition that affects approximately 30-50% of older adults and contributes to risk for cardiometabolic disorders and dementia. Despite the well-documented role of partners in treatment seeking and adherence to positive airway pressure (PAP), treatments for OSA have nearly exclusively focused on the patient and current treatments for OSA do not address co-existing sleep problems such as insomnia that are prevalent in both patients with OSA and their partners. Therefore, the goal of this study is to develop and test a novel couples-based sleep health intervention to promote adherence to PAP and improve sleep health of the couple. We are conducting a two-arm, parallel group, single blind, randomized controlled pilot/feasibility trial to compare our novel couples-based sleep health intervention (We-PAP) to an information control group (IC). We-PAP is based on a transdiagnostic model and uses a dyadic approach including increasing effective partner support, communication skills, and couple-level goal-setting. We-PAP involves 3 sessions and delivered via telehealth in weekly sessions. The IC includes standardized patient educational materials. Both groups receive the usual follow-up with their medical team. The study involves assessments at pre-treatment, post-intervention (approximately 1 month after starting PAP and completing We-PAP sessions or IC) and 3 months after starting PAP. Our main outcomes are feasibility and acceptability ratings. Secondary outcomes include comparing We-PAP to IC for PAP adherence, sleep quality (self-report and objective) and cognitive measures. We-PAP is the first couples-based transdiagnostic sleep health intervention for patients with OSA and their partners. Results of this study will be used to inform the design of a subsequent fully powered clinical trial. If successful, this intervention could significantly advance current clinical practice in the treatment of OSA and sleep health more comprehensively in older adults. Moreover, this intervention may be useful for improving sleep in other aging populations with multiple sleep and other health problems, including patients with chronic illnesses or those at risk for Alzheimer’s disease and their caregivers. NCT04759157. Date of registration: February 8, 2021. URL of trial registry record.