Mind over bladder: can sleep training curb nighttime urges?

NCT ID NCT07760779

Symptom relief Sponsor: University of Pittsburgh Source: ClinicalTrials.gov ↗

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether brief behavioral sleep therapy and mindfulness, alone or combined, can reduce how often older women wake up at night to urinate. Women aged 65 and older with frequent nocturia and poor sleep will be randomly assigned to one of four groups: sleep therapy, mindfulness, both, or a control with sleep information only. The study measures changes in nighttime urination frequency, urine volume, and sleep quality over several months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Brief behavioral treatment of insomnia (BBTI) and brief mindfulness intervention (MI), alone or combined
What this could lead to: If effective, these non-drug approaches could offer a safe way to reduce nighttime urination and improve sleep quality in older women.
What could go wrong: This is a small early-stage trial, and results may not apply to all women. The interventions require active participation and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

insomnia Nocturia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Nocturia

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Mind over bladder: can sleep training curb nighttime urges?

What the study statuses mean