Clinical Trial

Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness

Study acronym: ANOWSM
Not Yet Recruiting
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Summary
The goal of this clinical trial is to examine and compare the effect of behavioral sleep treatment: BBTI (brief behavioral treatment of insomnia) and brief mindfulness (MI), independently and combined vs control on frequency of nighttime awakenings to void (nocturia) and on nighttime urine production in older women over the age 65 years with nocturia. To study the effect of these treatments, participants will be randomly assigned to one of the following groups 1) BBTI alone, 2) MI alone, 3) BBTI+MI, or 4) control: sleep information only without any structured sleep or mindfulness therapy. The study aims to examine the effect of these therapies at end-of-treatment (week 4), as well sustained effects at 3- and 6-months. The main questions the study aims to answer are: 1. do these treatments reduce the frequency of nighttime awakenings to void 2. do these treatments reduce the volume of nighttime urine production 3. do these treatments improve sleep quality Frequency of nocturia and sleep quality will be assessed via questionnaires and nighttime urine volume using bladder-sleep diaries which is 3-day record participants will complete at home documenting every time they go to the bathroom and volume they voided. In addition, sleep and sleep interruptions will also be assessed using an FDA-cleared home sleep testing device called Zmachine®.
Trial Details
NCT Number NCT07760779
Lead Sponsor University of Pittsburgh
Collaborators: National Institute on Aging (NIA)
Conditions Nocturia, Insomnia
Enrollment 80 participants
Start Date 2026-09-15
Primary Completion 2028-10-30 (estimated)
Study Completion 2029-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-12