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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07760779
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brief behavioral treatment of insomnia — BEHAVIORAL
    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 — BEHAVIORAL
    Participants in the MI group will be trained to engage in a brief mindfulness method involving body scan with acceptance language training.
  • Control — BEHAVIORAL
    The control condition is intended to emulate the behavioral treatment information generally available to patients.
  • BBTI+MI — BEHAVIORAL
    Participants in this arm will receive BBTI as well as MI training.

Study Details

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 Dates

First listed
Aug 12, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Oct 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Control
  • Experimental: BBTI
    Brief behavioral treatment of insomnia
  • Experimental: MI
    Brief mindfulness
  • Experimental: BBTI+MI
    Brief behavioral treatment of insomnia and brief mindfulness

Primary Outcome Measure

Nocturia [ Time Frame: 4 weeks, 3- and 6-months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Shachi Tyagi, MD, MS
[email protected]
412-647-1274
Becky D Clarkson, PhD
[email protected]
412.647.1270

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By specialty
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By research site
University of Pittsburgh· Pittsburgh, PA

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