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

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®.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Nocturia
• Intervention / Treatment: Behavioral: Control; Behavioral: Brief behavioral treatment of insomnia; Behavioral: MI; Behavioral: BBTI+MI

Detailed Description

Nocturia, or waking at night to void, and poor sleep are prevalent and comorbid conditions in the elderly. Nocturia affects up to 70% of those over age 60, and over 75% of the older adults with poor sleep report nocturia as the main reason. Nocturia increases risk for falls, fractures, depression, institutionalization, and death. Poor sleep and nocturia have a bidirectional relationship and are mutually exacerbating. Nocturnal polyuria (NP) or excess urine production during sleep is the major contributor to nocturia in the elderly and poor sleep is known to cause NP. Vasopressin and aldosterone peak during sleep, causing sodium and water reabsorption in renal tubuli, which leads to decrease in nighttime urine production. Sleep loss leads to attenuation of the sleep time release of these hormones, resulting in natriuresis and diuresis causing NP.

Brief behavioral treatment of insomnia (BBTI- a brief 4-week, efficacious behavioral treatment for insomnia) is effective in addressing sleep and nocturia. Investigators found in their recently concluded pilot trial among older adults with comorbid nocturia (≥2/night) and poor sleep, that BBTI improved nocturia more than control (-0.9 vs -0.3, p=.016). Compared to control, BBTI improved subjective insomnia severity index (-5.9 vs -2.5, p=.02). Additionally, BBTI also improved NP: % of 24h urine volume excreted at night decreased in BBTI vs control (-7.1±13%, p=.001 vs -4±11, p=.08). Although BBTI is brief and effective for nocturia, adherence to behavioral sleep treatments among patients with chronic conditions (poor sleep, nocturia) is disappointingly low compared to patients with acute conditions, particularly several months after therapy. Moreover, the time and personnel needed to train professionals and to administer the intervention has limited the scalability of this otherwise promising treatment. Alternatives to boost treatment adherence and maintain benefit need to be investigated.

Recently the investigators trialed brief mindfulness (MI) training alone or paired with transcranial direct current stimulation (tDCS) in older women with urinary incontinence to enhance cognitive control over bladder symptoms. Of these women, those who had nocturia (≥1/night) and received MI training alone experienced improvement in nocturia (-0.5±0.6, p=0.005) with a concurrent increase in FUSP (39.8±70.2 minutes, p=0.02). Interestingly, effect of MI on nocturia and FUSP were similar to that seen with BBTI. MI requires only brief training followed by convenient at-home use. It was well liked in our study with an acceptability of 85.6 and compliance of 94.4 on a 1-100 Likert scale indicating MI may be a simpler and scalable modality either alone or to augment BBTI for reducing nocturia in older women.

This study a randomized pilot trial in older women with interrupted sleep due to nocturia to examine the effect of BBTI and MI on nocturia, nighttime urine production, and sleep quality at 4-week (post-intervention) and 3- and 6-months later. The investigators postulate that both interventions, individually and in combination, will be beneficial, and the combined treatment will lead to sustained treatment effects at 3- and 6-months.

The study will include older women with nocturia. Sleep will be assessed subjectively with the Pittsburgh Sleep Quality Index (PSQI) and objectively using Zmachine®, an FDA cleared in-home single channel EEG device, and a 3-day bladder-sleep diary that concurrently assesses sleep and voiding pattern including frequency and volume during day and night. Participants will be randomized to one of the 4 groups in a 2x2 factorial design: i) BBTI, ii) MI, iii) BBTI+MI or iv) control. Participants will repeat the study measures at 4 weeks, and 3- and 6-months.

The study aims to explore the effects of MI and BBTI. Hypothesis: Compared to control, BBTI and/or MI groups will result in greater improvement in 1) nocturia, 2) volume of nighttime urine volume, and 3) sleep quality at 4 weeks with the combined BBTI+MI intervention conferring greater benefits and sustained treatment effects at 3- and 6-months.

This study will be the first RCT to evaluate the effect of BBTI and MI, individually and combined on nocturia and sleep, and to assess durability of benefit. The results will provide novel information regarding the promise of efficient cost-effective, and easy to disseminate means of treating nocturia in older women and facilitate confirmatory trial to provide definitive evidence and develop clinically acceptable treatment protocols.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shachi Tyagi, MD, MS; Phone Number: 14126471274; Email: sht55@pitt.edu
• Study Contact Backup: Name: Becky D Clarkson, PhD; Phone Number: 4126471270; Email: bdc29@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
      • Contact: Shachi Tyagi, MD, MS; Phone Number: 412-647-1274; Email: sht55@pitt.edu
      • Contact: Becky D Clarkson, PhD; Phone Number: 412.647.1270; Email: bdc29@pitt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control	Behavioral: Control; The control condition is intended to emulate the behavioral treatment information generally available to patients.
Experimental: BBTI; Brief behavioral treatment of insomnia	Behavioral: 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: reduce time in bed;; get up at the same time every day, regardless of sleep duration;; do not go to bed unless sleepy; and; do not stay in bed unless asleep
Experimental: MI; Brief mindfulness	Behavioral: MI; Participants in the MI group will be trained to engage in a brief mindfulness method involving body scan with acceptance language training.
Experimental: BBTI+MI; Brief behavioral treatment of insomnia and brief mindfulness	Behavioral: BBTI+MI; Participants in this arm will receive BBTI as well as MI training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturia	number of nighttime awakenings to void	4 weeks, 3- and 6-months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal polyuria index (NPi)	percentage of 24-hour urine volume excreted at night	4 weeks, 3- and 6-months post-intervention
Pittsburgh Sleep Quality Index (PSQI)	Self-reported sleep quality questionnaire scored by grouping 19 self-rated questions into seven component scores, summing them into a global score (0 to 21)> PSQI score >5 Indicates significant, poor sleep quality and clinical sleep disturbance.	4-weeks, 3- and 6-month post intervention

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Shachi Tyagi, MD, MS, University of Pittsburgh; Study Chair: Shachi Tyagi, MD, MS, University of Pittsburgh; Study Director: Becky D Clarkson, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: August 7, 2026
• First Submitted That Met QC Criteria: August 7, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Nocturia
• Other Study ID Numbers: STUDY26040096; 1R21AG095656-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification may be shared with other researchers.
• IPD Sharing Time Frame: Following publication, no end date
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No