Status:
RECRUITING
Multi-center Trial to Improve Nocturia and Sleep in Older Adults
Lead Sponsor:
Atlanta VA Medical Center
Collaborating Sponsors:
VA Greater Los Angeles Healthcare System
Emory University
Conditions:
Nocturia
Insomnia
Eligibility:
All Genders
60+ years
Phase:
NA
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...
Detailed Description
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...
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
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06110091
Start Date
December 5 2023
End Date
August 1 2028
Last Update
September 30 2025
Active Locations (2)
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1
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 91343
2
Atlanta VAHCS
Atlanta, Georgia, United States, 30033