Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Who can join
Ages 65 and older · Women
Full eligibility criteria
Inclusion Criteria: * Female * Age \> or =65 years * Nocturia ≥2/night * Poor sleep (Insomnia Severity Index ≥8) * MoCA (including trail making) \>26 Exclusion Criteria: * Conditions that affect bladder function: Multiple sclerosis, Alzheimer's disease, spinal cord injury, urethral obstruction, urinary retention, interstitial cystitis, bladder cancer, radiation to the pelvic area, bladder surgery, current or uncontrolled chronic or recurrent bowel issues, bacterial endocarditis * cardiac or respiratory disease that limits daily function * Unstable or acute medical condition: \- Any acute medical condition that requires immediate treatment such that it would interfere with the study protocol; Each instance will be assessed on a case-by-case basis by our study physician who may postpone a participant's enrollment; stably managed chronic conditions are exempt from this exclusion. * Untreated, current, severe psychiatric condition (assessed during Visit 1a- medical history) * Post void residual ≥ 200ml- assessed during baseline visit * Currently diagnosed and/or untreated obstructive sleep apnea, untreated restless leg syndrome, untreated parasomnia * Untreated or poorly controlled fluid overload conditions like CHF, diabetes
About the study
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®.
What is being tested
- Brief behavioral treatment of insomnia (behavioral)
- MI (behavioral)
- Control (behavioral)
- BBTI+MI (behavioral)
Sponsor: University of Pittsburgh · Participants: 80 · Started: Oct 15, 2026
Contact the study team
- Shachi Tyagi, MD, MS · Phone: 14126471274
- Becky D Clarkson, PhD · Phone: 4126471270
Official record on ClinicalTrials.gov — NCT07760779
Locations in the U.S.
| Pennsylvania | University of Pittsburgh, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.