Recruiting

Observational Study

Sponsor:

Atlanta VA Medical Center

Code:

NCT06110091

Conditions

Nocturia

Insomnia

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Integrated Behavioral Therapy Program

Health Education Program

Study Details

Brief summary:

The Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT) study is a randomized trial to determine and assess the efficacy of integrated treatment of coexisting nocturia and insomnia, as well as explore the effects of this treatment on quality of life.

Conditions

Nocturia

Insomnia

Study ID

NCT06110091

Start date

Dec 5, 2023

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 60 years
  • Average of ≥ 2 episodes per night of nocturia on the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB) questionnaire
  • Insomnia Severity Index > 7
  • Able to attend weekly study visits

Exclusion Criteria:

  • Prior cognitive behavioral therapy for insomnia
  • Presence of bipolar disorder
  • Significant cognitive impairment as measured by a score < 20 on the Mini-Mental State Exam
  • Sleep disturbance better explained by another sleep disorder such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders
  • Untreated sleep-disordered breathing (respiratory event index ≥ 15 plus • Epworth Sleepiness Scale > 10 or respiratory event index > 30. Note that participants with treated sleep-disordered breathing will not be excluded)
  • Current urinary tract infection or hematuria
  • Unstable doses or recent changes in bladder medication
  • New or recently discontinued insomnia medication within past month
  • Previous or current intensive behavioral therapy for insomnia or urinary symptoms,
  • Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by overall study PIs or Site PI.
  • Unstable medical conditions that could contribute to nocturia or insomnia such as poorly controlled heart failure as evidenced on physical examination, poorly controlled diabetes mellitus with either hemoglobin A1c of ≥ 9.0, or chronic kidney disease (stage 4 or 5) or a potential to initiate dialysis in 3 months
  • Unstable psychiatric conditions (e.g., psychosis, active alcohol/substance abuse based on history and medical records)
  • Unstable housing situation
  • Evidence of significant urinary retention as measured by a residual bladder volume of ≥ 200 mL by bladder ultrasound with 15 minutes of voiding
  • Genitourinary cancer undergoing active treatment
  • Pelvic or colon surgery within 6 months of enrollment or onabotulinum toxin therapy for urinary symptoms within 6 months of enrollment

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Integrated Behavioral Therapy Program

Integrated Behavioral Therapy consists of 5 weekly one-hour sessions (face-to-face either through video or in-person) + 2 telephone check-in with an interventionist. This program integrates cognitive-behavioral treatment for nocturia and insomnia. Brief telephone check-ins will be comprised of review of topics discussed during the sessions.

placebo comparator: Health Education Program

The Health Education Program consists of 5 weekly one-hour sessions (face-to-face either through video or in-person) + 2 telephone check-in with an interventionist. The program modules focus on brain health and includes topics such physical activity, social engagement, sleep topics (e.g., changes in sleep that occur with aging, effects of poor sleep on health), medications/medical conditions, vision and hearing impairment. Brief telephone check-ins will be comprised of review of health topics discussed during the sessions.

Interventions

Integrated Behavioral Therapy Program

Integrated Behavioral Therapy is a behavioral program that includes education, lifestyle habits management, cognitive, relaxation, and behavioral conditioning for nocturia and insomnia

Health Education Program

Health Education Program modules focus on brain health and includes topics such physical activity, social engagement, sleep topics (e.g., changes in sleep that occur with aging, effects of poor sleep on health), medications/medical conditions, vision and hearing impairment.

Primary outcome measure

  • Mean Nocturia Frequency [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Taressa Sergent

(404) 315-4100Taressa.Sergent@va.gov

Patric Campbell

(404) 315-4100Patric.Campbell@va.gov

Locations

VA Greater Los Angeles Healthcare System

Recruiting

Los Angeles, California, United States, 91343

Contacts

Erin E Der-Mcleod

818-891-7711Erin.Der-mcleod@va.gov

Principal Investigator:

Constance H Fung, MD, MSHS

Atlanta VAHCS

Recruiting

Atlanta, Georgia, United States, 30033

Contacts

E Camille Vaughan, MD, MS

404 315 4100elizabeth.vaughan2@va.gov

Taressa Sergent

404 315 4100Taressa.Sergent@va.gov

More Information

Sponsor

Atlanta VA Medical Center

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Atlanta VA Medical Center on 2026-08-13.