Actively Recruiting
Multi-center Trial to Improve Nocturia and Sleep in Older Adults
Led by Atlanta VA Medical Center · Updated on 2025-09-30
192
Participants Needed
2
Research Sites
243 weeks
Total Duration
On this page
Sponsors
A
Atlanta VA Medical Center
Lead Sponsor
V
VA Greater Los Angeles Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Multi-center Trial to Improve Nocturia and Sleep in Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- At least 2 episodes of nocturia per night based on the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB)
- Insomnia Severity Index score greater than 7
- Ability to attend weekly study visits
You will not qualify if you...
- Prior cognitive behavioral therapy for insomnia
- Diagnosis of bipolar disorder
- Significant cognitive impairment with Mini-Mental State Exam score less than 20
- Sleep disturbances better explained by other sleep disorders such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders
- Untreated sleep-disordered breathing with respiratory event index 15 or higher plus Epworth Sleepiness Scale over 10, or respiratory event index over 30
- Current urinary tract infection or presence of blood in urine
- Unstable or recently changed bladder medication doses
- Use of new or recently stopped insomnia medications within the past month
- Previous or current intensive behavioral therapy for insomnia or urinary symptoms
- Unstable health conditions expected to cause death or hospitalization within 3 months
- Unstable medical conditions contributing to nocturia or insomnia, such as poorly controlled heart failure, poorly controlled diabetes with hemoglobin A1c 9.0 or higher, chronic kidney disease stage 4 or 5, or likely need for dialysis within 3 months
- Unstable psychiatric conditions, including psychosis or active substance abuse
- Unstable housing situation
- Significant urinary retention with bladder residual volume 200 mL or higher
- Active treatment for genitourinary cancer
- Pelvic or colon surgery within 6 months or onabotulinum toxin therapy for urinary symptoms within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 91343
Actively Recruiting
2
Atlanta VAHCS
Atlanta, Georgia, United States, 30033
Actively Recruiting
Research Team
T
Taressa Sergent
CONTACT
P
Patric Campbell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here