Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness

NCT07760779 | Not Yet Recruiting

• 2 other identifiers: STUDY260400961R21AG095656-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.do these treatments reduce the frequency of nighttime awakenings to void
2. 2.do these treatments reduce the volume of nighttime urine production
3. 3.do these treatments improve sleep quality

Conditions

Nocturia; Insomnia

Outcome Measures

Primary Outcomes (1)

• Nocturia

  number of nighttime awakenings to void

  4 weeks, 3- and 6-months post-intervention

Other Outcomes (2)

• Nocturnal polyuria index (NPi)

  4 weeks, 3- and 6-months post-intervention

• Pittsburgh Sleep Quality Index (PSQI)

  4-weeks, 3- and 6-month post intervention

Study Arms (4)

Control

OTHER

Behavioral: Control

BBTI

EXPERIMENTAL

Brief behavioral treatment of insomnia

Behavioral: Brief behavioral treatment of insomnia

MI

EXPERIMENTAL

Brief mindfulness

Behavioral: MI

BBTI+MI

EXPERIMENTAL

Brief behavioral treatment of insomnia and brief mindfulness

Behavioral: BBTI+MI

Interventions

Brief behavioral treatment of insomnia BEHAVIORAL

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

BBTI

MI BEHAVIORAL

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

MI

Control BEHAVIORAL

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

Control

BBTI+MI BEHAVIORAL

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

BBTI+MI

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Nocturia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Shachi Tyagi, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Shachi Tyagi, MD, MS

  University of Pittsburgh

  STUDY CHAIR

• Becky D Clarkson, PhD

  University of Pittsburgh

  STUDY DIRECTOR

Central Study Contacts

Shachi Tyagi, MD, MS

CONTACT

14126471274; sht55@pitt.edu

Becky D Clarkson, PhD

CONTACT

4126471270; bdc29@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following publication, no end date

Locations

US (1)