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.

夜尿症发生在近50%的老年人和慢性失眠症发生在多达三分之一的老年人。 老年人这两种情况经常共存于同一个人，并有助于睡眠 扰动作为一种老年综合症，睡眠障碍的原因是多因素的，并且存在一些危险因素 和健康状况协同作用，增加了单个个体的风险。然而， 失眠症或失眠症通常集中于个体状况（例如，不解决其他问题 条件（例如，失眠）。鉴于这两种情况的协同作用， 失眠症和失眠症都有可能在每种情况下产生显着的改善 整体睡眠。 最近的证据支持未来对失眠症和失眠症进行综合治疗的试验， 特别是采用非药物、非手术策略的方法。研究发现， 对失眠症的治疗改善了失眠症状和睡眠质量。同样，行为治疗 失眠减少失眠频率和烦恼。在我们最近试点的多成分行为干预中， 其结合了睡眠相关的（即，睡眠卫生）和睡眠障碍（例如，骨盆底肌肉锻炼- 基于夜间冲动抑制）治疗，干预降低了排尿频率等于或优于 而不是药物治疗建议的综合治疗解决了以下两个方面的双向关系： 失眠症和失眠症。夜间失眠增加了个体感觉到空虚冲动的机会。 夜尿症也会导致觉醒，难以恢复睡眠，以及在床上呆的时间过长， 失眠和增加的机会，感觉到的冲动，以无效。我们的初步研究结果表明，一个完整的- 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申请的目的是计划未来的多中心临床试验，该试验将测试一种新的， 综合非药物（行为、认知和生活方式）治疗共存的精神分裂症， 老年人的失眠症这个为期5周的治疗的核心组成部分（由先进的 实践提供者，如护士执业）将包括有关这两种情况的教育， 互动，两种情况下的行为调节练习，两种情况下的放松练习 条件，睡眠限制（失眠认知行为疗法的核心组成部分），骨盆底 肌肉训练、生活习惯管理、认知重建和应对技巧。一个完整的， 需要多点试验来确定综合方案在改善睡眠和失眠方面的疗效。 结果具有足够的把握度和多个研究中心的可推广性。在本申请中，我们提出 规划活动（开发，完善和测试）的协议和程序，为未来的全面 在多个研究中心进行的试验。该研究小组，其中包括建立调查与专业知识， 泌尿系统症状，睡眠障碍，临床试验和卫生服务研究，一直在合作， 推进失眠症研究领域。