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.

项目总结 夜尿症(在主要睡眠期间醒来排尿)每晚发生两次或两次以上。 近50%的老年人，由于其潜在的严重的尿路症状，是最令人烦恼的尿路症状之一 对睡眠的影响。然而，老年人的夜尿症通常仅被视为一种泌尿系统疾病，尽管 它也是一种睡眠状态，因为它涉及到“主要睡眠周期”的干扰。膀胱、前列腺和 抗利尿药物、限制液体、膀胱训练和盆底肌肉锻炼通常是 处方，但所有治疗的有效性是有限的，药物副作用包括精神错乱和 跌倒是老年人的问题。这项研究的长期目标是开发一种安全的、跨专业的 治疗将改善患有夜尿症的老年人的生活。 尽管有可用的治疗方法，但夜尿率高的一个原因是，目前的治疗方法 忽略导致夜间觉醒的非下尿路因素。例如，认知 白天午睡引起的高度觉醒和动态平衡睡眠减少可能会增加 唤醒并感觉到作废的冲动；不适应的补偿行为可能会导致时间过长 上床睡觉，从而增加感觉到空虚的冲动的机会。失眠的认知行为疗法 有效地减少夜间失眠，早期证据表明，它还可以减少夜尿症。不幸的是， 夜尿症治疗跨越专科，并以协调的方式提供泌尿和睡眠治疗 是一种治疗障碍。 拟议项目的总体目标是确定一个协调的、综合的非 药物治疗，非手术治疗，同时治疗泌尿系统和失眠 夜尿诱因对改善夜尿、睡眠和日间功能有效。结果来自 我们由NIA支持的R34多站点规划赠款证明了新的夜尿症失眠的可行性 计划-综合治疗(NIP-IT)计划，其中整合了最佳实践行为治疗策略 用于夜尿症和认知行为疗法的失眠成分，以减少觉醒和排尿 由于其他原因，夜间唤醒的频率。建议进行这项研究的理由是 解决过度觉醒、条件性反应和不适应的想法/行为，并增加 动态平衡睡眠驱动力对减少夜间尿频和夜间觉醒以及改善 与夜尿症相关的总体生活质量。我们现在提出一项随机试验(n=192)，比较NIP-IT和 健康教育控制计划为60岁以上有夜尿症和失眠症状的成年人提供 NIP-IT计划在减少夜尿症发作和睡眠方面的有效性的严格、确凿的证据 骚乱。我们还将评估对夜尿症和睡眠相关生活质量的影响。