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 夜尿症（在主要睡眠期间醒来排尿）每晚发生两次或更多次， 近50%的老年人，是最麻烦的泌尿系统症状之一，由于其潜在的严重性， 对睡眠的影响然而，老年人的尿失禁通常被视为仅仅是一种泌尿系统疾病， 它也是一种睡眠状况，因为它涉及“主睡眠期”的干扰。膀胱前列腺还有 抗利尿药物、液体限制、膀胱训练和骨盆底肌肉锻炼通常 处方，但所有治疗的有效性是有限的，药物副作用，包括谵妄和 福尔斯在老年人中很受关注。本研究的长期目标是开发一种安全、跨专业的 改善老年痴呆症患者生活的治疗方法。 尽管有可用的治疗方法，但对高发病率的一种解释是，目前的方法 忽视非下尿路因素，有助于夜间觉醒。例如认知 白天小睡引起的过度觉醒和稳态睡眠驱动力下降可能会增加 唤起和感觉到排泄的冲动;适应不良的补偿行为可能导致过多的时间， 床，从而增加机会，感觉到冲动，以空。失眠症的认知行为疗法 有效地减少了夜间失眠，早期的证据表明它也减少了失眠。不幸的是， 泌尿系疾病治疗跨越专业，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、综合的非政府组织是否能够在其活动中发挥作用， 药理学，非手术治疗，同时解决泌尿和失眠 导致失眠的因素对改善失眠、睡眠和日间功能有效。结果 我们的NIA支持的R34多站点规划拨款证明了新型夜尿抑制剂的可行性 计划-综合治疗（NIP-IT）计划，整合了最佳实践行为治疗策略 用于失眠和认知行为疗法的失眠成分，以减少觉醒和尿 由于其他原因，夜间醒来的频率。拟议研究的理由是， 解决过度觉醒、条件反射和适应不良的想法/行为， 自我平衡睡眠驱动对于减少失眠频率和夜间觉醒以及改善 与生活质量相关的整体生活质量。我们现在提出了一项随机试验（n=192），比较NIP-IT和 对60岁以上老年人失眠症患者实施健康教育控制方案 NIP-IT计划减少夜尿发作和睡眠的功效的严格、明确的证据 扰动我们还将评估对睡眠和睡眠相关生活质量的影响。