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Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Sponsor: University of Pittsburgh
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®.
Key Details
Gender
FEMALE
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-09-15
Completion Date
2029-04-30
Last Updated
2026-08-12
Healthy Volunteers
No
Interventions
Brief behavioral treatment of insomnia
BBTI: will entail a 45- to 60-minute individual intervention session with instructions regarding sleep education and discussion of homeostatic and circadian mechanisms of human sleep regulation. This education provides the rationale for the 4 main interventions of BBTI: 1. reduce time in bed; 2. get up at the same time every day, regardless of sleep duration; 3. do not go to bed unless sleepy; and 4. do not stay in bed unless asleep
MI
Participants in the MI group will be trained to engage in a brief mindfulness method involving body scan with acceptance language training.
Control
The control condition is intended to emulate the behavioral treatment information generally available to patients.
BBTI+MI
Participants in this arm will receive BBTI as well as MI training.
Locations (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, United States