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Sleep therapy and mindfulness for night-time urination in older women with insomnia

Tests sleep therapy and mindfulness for waking to urinate in older women.

Key facts

Who runs it
University of Pittsburgh
Where
Pittsburgh, United StatesSee the site
Trial code
Registry title
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Status
Recruiting
People taking part
80 people, planned
Started
15 Oct 2026
Expected to end
30 Apr 2029
Type of study
Interventional, 4 groups
Treatments tested
  • Brief behavioral treatment of insomnia
  • MI
  • Control
  • BBTI+MI
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 65 or older who wake up at night to pass urine (nocturia) and sleep poorly. It tests sleep therapy and mindfulness.

Age
65 years or older
Sex
Women only
Disease stage
Waking at night to pass urine at least 2 times per night. Poor sleep, with an Insomnia Severity Index score of 8 or more. A memory and thinking test (MoCA, including trail making) score above 26.

Main reasons for not taking part

  • Conditions that affect the bladder, such as multiple sclerosis, Alzheimer's disease, spinal cord injury, bladder cancer, pelvic radiation or bladder surgery
  • Heart or lung disease that limits daily life
  • Unstable or sudden medical problem needing immediate treatment, or an untreated severe mental health condition
  • Urine left in the bladder after passing urine of 200ml or more
  • Untreated sleep apnea, restless legs or parasomnia, or untreated or poorly controlled fluid overload conditions like heart failure (CHF) or diabetes

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Female
  • Age > or =65 years
  • Nocturia ≥2/night
  • Poor sleep (Insomnia Severity Index ≥8)
  • MoCA (including trail making) >26

Who cannot take part

  • 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)
  • Currently diagnosed and/or untreated obstructive sleep apnea, untreated restless leg syndrome, untreated parasomnia
  • Untreated or poorly controlled fluid overload conditions like CHF, diabetes
  • Post void residual ≥ 200ml- assessed during baseline visit

Where in United States

  • University of PittsburghPittsburgh, United StatesContact: Shachi Tyagi, MD, MSTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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®.

The 4 groups in the trial

  • ControlOther group
  • BBTITreatment being tested

    Brief behavioral treatment of insomnia

    Treatment: Brief behavioral treatment of insomnia

  • MITreatment being tested

    Brief mindfulness

  • BBTI+MITreatment being tested

    Brief behavioral treatment of insomnia and brief mindfulness

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Plain-language title
Sleep therapy and mindfulness for night-time urination in older women with insomniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
6 November 2026