A multi-center trial to improve nocturia and sleep in older adults

一项改善老年人夜尿和睡眠的多中心试验

• 批准号: 10718768
• 负责人: Constance Fung
• 金额: $ 58.98万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10718768
• 关键词: Address; Adult; Affect; Aftercare; Beds; Behavior; Behavior Therapy; Behavioral; Bladder; Clinical Trials; Cognitive; Cognitive Therapy; Collaborations; Conditioned Reflex; Consent; Delirium; Education; Effectiveness; Elderly; Exercise; Frequencies; Goals; Grant; Habits; Health Services Research; Health education; Increased frequency of micturition; Life Style; Liquid substance; Multicenter Trials; Napping; Nocturia; Participant; Patient Self-Report; Pelvic Floor Muscle; Personal Satisfaction; Pharmaceutical Preparations; Pharmacological Treatment; Pittsburgh Sleep Quality Index; Positioning Attribute; Procedures; Prostate; Quality of life; Randomized; Relaxation; Reporting; Research; Research Personnel; Risk; Safety; Severities; Site; Sleep; Sleep disturbances; Sleeplessness; Symptoms; Thinking; Time; Training; Treatment Protocols; Urine; Wakefulness; aged; antidiuretic; comparison control; conditioning; efficacy evaluation; falls; follow-up; functional improvement; improved; indexing; medical specialties; novel; programs; randomized trial; side effect; sleep onset; sleep quality; treatment program; treatment strategy; urinary; urologic

PROJECT SUMMARY Nocturia (waking to pass urine during the main sleep period) occurs two or more times per night in nearly 50% of older adults and is among the most bothersome urinary symptoms, due to its potentially severe impact on sleep. However, nocturia in older adults is often viewed solely as a urological condition even though it is also a sleep condition since it involves disturbances of the “main sleep period.” Bladder, prostate, and antidiuretic medications, fluid restriction, bladder training, and pelvic floor muscle exercises are often prescribed, but the effectiveness of all treatments is limited and medication side effects including delirium and falls are concerning in older adults. The long-term goal of this research is to develop a safe, cross-specialty treatment that will improve the lives of older adults with nocturia. One explanation for the high rates of nocturia despite available treatments is that current approaches overlook non-lower urinary tract factors that contribute to nighttime awakenings. For example, cognitive hyperarousal and decreased homeostatic sleep drive from daytime napping may increase the tendency to arouse and sense the urge to void; and maladaptive compensatory behaviors may lead to excessive time in bed, thereby increasing opportunity to sense the urge to void. Cognitive behavioral therapy for insomnia effectively reduces nighttime wakefulness and early evidence suggests it also reduces nocturia. Unfortunately, nocturia treatment crosses specialties, and delivering urological and sleep therapies in a coordinated manner is a treatment barrier. The overall objective of the proposed project is to determine whether a coordinated, integrated non- pharmacological, non-surgical treatment that simultaneously addresses both the urological and insomnia factors contributing to nocturia is efficacious for improving nocturia, sleep, and daytime function. Results from our NIA-supported R34 multisite planning grant demonstrate the feasibility of the novel Nocturia Insomnia Program-Integrated Treatment (NIP-IT) program, which integrates best practice behavioral treatment strategies for nocturia and cognitive behavioral therapy for insomnia components to reduce awakenings and urinary frequency during nighttime awakenings due to other reasons. The rationale for the proposed research is that addressing hyperarousal, conditioned responses, and maladaptive thoughts/behaviors and increasing homeostatic sleep drive are critical to reducing nocturia frequency and nighttime wakefulness and improving overall nocturia-related quality of life. We now propose a randomized trial (n=192) comparing NIP-IT to a health education control program in adults aged > 60 with nocturia and insomnia symptoms to provide rigorous, definitive evidence of the efficacy of the NIP-IT program to reduce both nocturia episodes and sleep disturbance. We will also assess impact on nocturia and sleep-related quality of life.

项目摘要 夜尿（在主要睡眠期间醒来尿液）每晚发生两次或更多次 近50％的老年人是最严重的泌尿症状之一 对睡眠的影响。但是，尽管 这也是睡眠状况，因为它涉及“主要睡眠期”的灾难。膀胱，前列腺和 抗利尿药，液体限制，膀胱训练和骨盆底肌肉运动通常是 规定，但所有治疗的有效性都是有限的，药物副作用，包括ir妄和 瀑布对老年人关注。这项研究的长期目标是开发安全，跨性别 可以改善夜尿老年人生活的治疗。 关于Nocturia目的地可用治疗率高的高率的一种解释是当前的方法 忽略有助于夜间觉醒的非低尿路因子。例如，认知 从白天小睡开始的高阳光和改善的稳态睡眠驱动器可能会增加 唤起并感知失效的冲动；和适应不良的补偿行为可能导致时间过多 床，越来越有机会感知失效的冲动。失眠的认知行为疗法 有效地降低了夜间的清醒，早期证据表明它也减少了夜尿。很遗憾， Nocturia治疗横穿专业，并以协调的方式提供泌尿外科和睡眠疗法 是治疗障碍。 拟议项目的总体目的是确定是否协调的，综合的非 - 药理，非手术治疗，仅解决泌尿外科和失眠症 导致夜尿的因素有效地改善了夜尿，睡眠和白天功能。结果 我们的NIA支持的R34多站点计划赠款证明了新颖的夜尿失眠的可行性 计划集成治疗（NIP-IT）计划，该计划整合了最佳实践行为治疗策略 用于夜尿和认知行为疗法，用于减少觉醒和尿液 由于其他原因，夜间觉醒的频率。拟议研究的理由是 解决高音，条件的反应和不良适应性思想/行为并增加 体内稳态睡眠驱动器对于降低夜尿频率和夜间清醒至关重要 总体而言，与夜尿相关的生活质量。现在，我们提出了一个随机试验（n = 192），将NIP-IT与A进行比较 成人的健康教育控制计划> 60岁，患有夜尿和失眠症状 严格的，确定的证据表明NIP-IT计划的效率减少了夜尿发作和睡眠 干扰。我们还将评估对夜尿和与睡眠有关的生活质量的影响。