Managing nighttime voiding in older women with sleep strategies
Official title: Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Run by University of Pittsburgh · NCT07760779 · Data updated 2026-11-12
This study tests whether brief behavioral sleep therapy and mindfulness, alone or together, reduce how often older women wake at night to urinate and how much urine they produce at night.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | October 15, 2026 |
| Main results expected | October 30, 2028 |
| Study ends | April 30, 2029 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07760779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women 65+ with nocturia of ≥2 awakenings per night and poor sleep, who are cognitively intact (MoCA > 26) and do not have certain exclusionary bladder or major medical/psychiatric conditions.
✕Probably not a fit
Participants with unstable medical conditions, significant bladder diseases, or untreated severe psychiatric conditions may not benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares four groups: brief behavioral treatment for insomnia (BBTI) alone, mindfulness intervention (MI) alone, both BBTI and MI, and a sleep-education control. Participants are women aged 65 and older with nocturia (≥2 awakenings per night) and poor sleep, and they will be followed for end-of-treatment at 4 weeks and for 3- and 6-month follow-ups. Outcomes include frequency of nocturnal voiding, nighttime urine volume, and overall sleep quality. The study builds on prior data suggesting BBTI can reduce nocturia and improve sleep, and it examines whether adding MI or combining therapies provides additional benefit.
Why it matters
Potential benefit: If successful, participants could experience fewer nighttime awakenings and better sleep quality, improving daytime function and reducing fall risk.
How similar studies have gone: Earlier pilots suggested BBTI can reduce nocturia and improve sleep; this trial tests whether mindfulness adds additional benefit.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Shachi Tyagi, MD, MS — University of Pittsburgh
- Study coordinator: Shachi Tyagi, MD, MS
- Email: sht55@pitt.edu
- Phone: 14126471274
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.