Recruiting

BBTI & MI

Sponsor:

University of Pittsburgh

Code:

NCT07760779

Conditions

Nocturia

Insomnia

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Brief behavioral treatment of insomnia

MI

Control

BBTI+MI

Study Details

Brief summary:

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®.

Conditions

Nocturia

Insomnia

Study ID

NCT07760779

Start date

Oct 15, 2026

Status verified date

Nov, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Brief behavioral treatment of insomnia

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

Participants in the MI group will be trained to engage in a brief mindfulness method involving body scan with acceptance language training.

Control

The control condition is intended to emulate the behavioral treatment information generally available to patients.

BBTI+MI

Participants in this arm will receive BBTI as well as MI training.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Shachi Tyagi, MD, MS

14126471274sht55@pitt.edu

Becky D Clarkson, PhD

4126471270bdc29@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Shachi Tyagi, MD, MS

412-647-1274sht55@pitt.edu

Becky D Clarkson, PhD

412.647.1270bdc29@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.