Coexisting nocturia and insomnia in older adults: Planning a trial of integrated therapy

老年人共存夜尿和失眠：计划综合治疗试验

• 批准号: 10205964
• 负责人: Constance Fung
• 金额: $ 10.99万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-15 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10205964
• 关键词: Address; Adult; Beds; Behavior Therapy; Behavioral; Chronic Insomnia; Clinical Practice Guideline; Clinical Trials; Cognitive; Cognitive Therapy; Data Collection; Education; Elderly; Enrollment; Exercise; Foundations; Frequencies; Future; Habits; Health; Health Services Research; Individual; Intervention; Intervention Trial; Life Style; Manuals; Measures; Methods; Multi-Institutional Clinical Trial; Nocturia; Nurse Practitioners; Outcome; Participant; Pelvic Floor Muscle; Personal Satisfaction; Pharmacological Treatment; Pharmacotherapy; Pilot Projects; Population; Positioning Attribute; Procedures; Protocols documentation; Provider; Randomized; Randomized Controlled Trials; Relaxation; Research; Research Personnel; Risk; Risk Factors; Severities; Site; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Standardization; Symptoms; Syndrome; Target Populations; Techniques; Testing; Therapeutic; Time; Training; Treatment Protocols; Visit; Wakefulness; base; comparative effectiveness trial; conditioning; coping; effectiveness evaluation; efficacy evaluation; group intervention; improved; multi-site trial; novel; older men; older women; programs; recruit; sleep health; sleep quality; success; synergism; urinary

Nocturia occurs in nearly 50% of older adults and chronic insomnia disorder occurs in up to one-third of older adults. These two conditions frequently coexist in the same individual and contribute to sleep disturbance. As a geriatric syndrome, the causes of sleep disturbance are multifactorial and some risk factors and health conditions act synergistically to increase the risk within a single individual. Yet treatments for either nocturia or insomnia typically focus on an individual condition (e.g., nocturia) without addressing the other condition (e.g., insomnia). Given the synergism of these two conditions, an integrated treatment that addresses both nocturia and insomnia simultaneously has the potential to yield significant improvements in each condition and overall sleep. Recent evidence supports a future trial of integrated treatment for nocturia and insomnia disorder, particularly one that employs non-pharmacologic, non-surgical strategies. Studies find that behavioral treatment for nocturia improves insomnia symptoms and sleep quality. Similarly, behavioral treatments for insomnia reduce nocturia frequency and bother. In our recently piloted multicomponent behavioral intervention, which incorporated both sleep-related (i.e., sleep hygiene) and nocturia (e.g., pelvic floor muscle exercise- based urge suppression at night) treatments, the intervention reduced nocturia frequency equal to or better than drug therapy. The proposed integrated treatment addresses the bidirectional relationship between nocturia and insomnia. Wakefulness at night increases the opportunity for individuals to sense the urge to void. Nocturia also contributes to awakenings, difficulty returning to sleep, and excessive time in bed, which worsens insomnia and increases the opportunity to sense the urge to void. Our pilot study results suggest that a full- scale, comparative-effectiveness trial is needed to test this promising treatment. The objective of this R34 application is to plan for a future multi-site clinical trial that will test a novel, integrated non-pharmacologic (behavioral, cognitive, and lifestyle) treatment for coexisting nocturia and insomnia in an older adult population. The core components of this 5-week treatment (delivered by advanced practice providers such as nurse practitioners) will include education about the two conditions and their interactions, behavioral conditioning exercises for both conditions, relaxation exercises for both conditions, sleep restriction (a core component of cognitive behavioral therapy for insomnia), pelvic floor muscle training, lifestyle habits management, cognitive restructuring, and coping techniques. A full-scale, multisite trial is needed to determine the efficacy of the integrated program in improving sleep and nocturia outcomes with adequate power and with generalizability across multiple sites. In this application we propose the planning activities (developing, refining, and testing) of the protocol and procedures for a future full-scale trial conducted at multiple sites. The research team, which includes established investigators with expertise in urinary symptoms, sleep disorders, clinical trials, and health services research, has been collaborating to advance the field of nocturia-insomnia research.

近 50% 的老年人患有夜尿症，多达三分之一的老年人患有慢性失眠症 老年人。这两种情况经常同时存在于同一个人身上并影响睡眠 干扰。作为一种老年综合症，睡眠障碍的原因是多因素的，其中一些危险因素 和健康状况协同作用，增加单个个体的风险。然而治疗方法 夜尿症或失眠症通常只关注某一种情况（例如夜尿症），而不关注其他情况 状况（例如失眠）。鉴于这两种情况的协同作用，需要采取综合治疗来解决 夜尿症和失眠症同时存在，有可能显着改善每种情况 和整体睡眠。 最近的证据支持未来对夜尿症和失眠症进行综合治疗的试验， 特别是采用非药物、非手术策略的一种。研究发现，行为 夜尿症治疗可改善失眠症状和睡眠质量。同样，行为治疗 失眠减少夜尿频率和烦恼。在我们最近试点的多成分行为干预中， 其中包括与睡眠相关的（即睡眠卫生）和夜尿（例如盆底肌肉锻炼） 基于夜间冲动抑制）治疗，干预措施将夜尿频率降低等于或更好 比药物治疗。所提出的综合治疗解决了之间的双向关系 夜尿和失眠。夜间清醒会增加人们感受到排尿冲动的机会。 夜尿还会导致觉醒、入睡困难以及卧床时间过长，从而导致病情恶化 失眠并增加感觉到排尿冲动的机会。我们的试点研究结果表明，全面 需要进行大规模的比较有效性试验来测试这种有希望的治疗方法。 该 R34 申请的目标是规划未来的多中心临床试验，该试验将测试一种新颖的、 针对共存的夜尿症和夜尿症的综合非药物（行为、认知和生活方式）治疗 老年人群的失眠。这个为期 5 周的治疗的核心组成部分（由先进的 实践提供者（例如执业护士）将包括有关这两种情况及其影响的教育 互动、针对两种情况的行为调节练习、针对两种情况的放松练习 状况、睡眠限制（失眠认知行为疗法的核心组成部分）、盆底 肌肉训练、生活习惯管理、认知重建和应对技巧。一个全面的、 需要进行多中心试验来确定综合方案在改善睡眠和夜尿方面的功效 结果具有足够的力量和跨多个站点的普遍性。在此应用中，我们建议 未来全面的协议和程序的规划活动（开发、完善和测试） 在多个地点进行了试验。研究团队包括具有以下专业知识的资深研究人员 泌尿系统症状、睡眠障碍、临床试验和健康服务研究，一直在合作 推进夜尿失眠研究领域。