Fung Constance H, Huang Alison J, Markland Alayne D, Schembri Michael, Martin Jennifer L, Bliwise Donald L, Cheng Jing, Alessi Cathy A, Johnson Theodore M, Burgio Kathryn L, Muirhead Lisa, Neymark Alison, Der-Mcleod Erin, Sergent Taressa, Chang Ann, Bauer Scott R, Spencer Colette, Guzman Andrew, Vaughan Camille P
Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California, USA.
Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
J Am Geriatr Soc. 2025 Feb;73(2):558-565. doi: 10.1111/jgs.19214. Epub 2024 Oct 10.
Nocturia (waking from sleep at night to void) and chronic insomnia frequently co-exist in older adults, contributing synergistically to sleep disturbance. Treatments typically target either nocturia or insomnia rather than simultaneously addressing shared mechanisms for these disorders.
We conducted a multisite feasibility study to: (1) test and refine a protocol for recruitment, randomization, and assessment of older adults with co-existing nocturia and insomnia; and (2) examine preliminary changes in outcome measures to inform a future larger, multisite clinical trial. Participants were men and women aged 60 years and older recruited from outpatient clinics, reporting an average of two or more nocturia episodes per night over the past 4 weeks and meeting diagnostic criteria for chronic insomnia disorder. Participants were randomized to receive either integrated cognitive-behavioral therapy for insomnia and nocturia or a health education control program involving five weekly visits with a trained nurse practitioner interventionist. Outcomes (e.g., nocturia episodes) were measured 1-week post-treatment and 4-month post-randomization. Descriptive statistics examined the feasibility of outcomes to guide preparations for a future efficacy trial.
Of 245 adults screened, 55% were ineligible and 25% declined to participate. Sixty-one percent of 49 participants who provided informed consent were randomized. Of the 30 participants randomized (mean age = 70.6 years, 60% White), 14 were assigned to integrated cognitive-behavioral treatment and 16 to the control group. All randomized participants provided 4-month follow-up data. At 4 months, mean nightly nocturia episodes decreased by 0.9 (SD 1.0) in the integrated treatment group and by 0.2 (SD 1.2) in the control group compared with baseline.
Findings demonstrate the feasibility of recruiting, randomizing, and collecting outcome data from older adults (predominantly male) assigned to an integrated cognitive-behavioral therapy for coexisting insomnia and nocturia or a health education control program.
夜尿症（夜间睡眠中醒来排尿）和慢性失眠在老年人中经常同时存在，协同导致睡眠障碍。治疗通常针对夜尿症或失眠，而不是同时解决这些疾病的共同机制。
我们进行了一项多中心可行性研究，目的是：（1）测试并完善一项针对同时患有夜尿症和失眠的老年人的招募、随机分组和评估方案；（2）检查结局指标的初步变化，为未来更大规模的多中心临床试验提供依据。参与者为年龄在60岁及以上的男性和女性，从门诊招募而来，报告在过去4周内平均每晚有两次或更多次夜尿发作，且符合慢性失眠障碍的诊断标准。参与者被随机分配接受针对失眠和夜尿症的综合认知行为疗法，或接受健康教育对照项目，该项目包括每周与一名经过培训的执业护士干预者进行五次访视。在治疗后1周和随机分组后4个月测量结局指标（如夜尿发作次数）。描述性统计分析检查了结局指标的可行性，以指导未来疗效试验的准备工作。
在245名筛查的成年人中，55%不符合条件，25%拒绝参与。在49名提供知情同意的参与者中，61%被随机分组。在30名被随机分组的参与者中（平均年龄 = 70.6岁，60%为白人），14人被分配到综合认知行为治疗组，16人被分配到对照组。所有随机分组的参与者均提供了4个月的随访数据。在4个月时，与基线相比，综合治疗组平均每晚夜尿发作次数减少了0.9（标准差1.0），对照组减少了0.2（标准差1.2）。
研究结果表明，从被分配接受针对同时存在的失眠和夜尿症的综合认知行为疗法或健康教育对照项目的老年人（主要为男性）中进行招募、随机分组并收集结局数据是可行的。
