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MINT Study: Improving Nocturia and Sleep in Older Adults

This study, called MINT, is looking for older adults aged 60 and above who experience frequent nighttime urination (nocturia) at least twice per night and have symptoms of insomnia. It aims to see how well an Integrated Behavioral Therapy Program works to improve both conditions. This program includes education, lifestyle changes, and relaxation techniques. Another group will receive a Health Education Program focusing on brain health. The main goal is to see if the Integrated Behavioral Therapy Program reduces how often you wake up to urinate at night after four months. The study is currently recruiting participants.

Study design
This is a randomized interventional study planning to enroll 192 participants.
What's involved
You would need to be able to attend weekly study visits.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06110091

Multi-center Trial to Improve Nocturia and Sleep in Older Adults

Recruiting
NAAges 60+InterventionalTreatment
Atlanta VA Medical Center
~192 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Integrated Behavioral Therapy ProgramHealth Education Program

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Nocturia Frequency
Measured over 4 months

Conditions

Nocturia
Insomnia

Explore related trials

InsomniaNocturia

Where it's being run

2 sites across 2 states
California1
Georgia1

Study leadership

  • E. Camille Vaughan, MD, MS · PRINCIPAL_INVESTIGATOR · Atlanta VAMC & Emory University

Who to contact

Taressa Sergent
[email protected]
(404) 315-4100 · ext. 373124
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Mean Nocturia Frequency4 months

    The primary outcome of nocturia frequency will be measured as the average episodes per night at baseline, 2 months, and 4 months through the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB) questionnaire. An adapted version that asks the participant to record the number of nocturia episodes if the "4+" nocturia option is selected will be used. A linear mixed effects model will be used to evaluate the group difference over time in average nocturia frequency per night.