Improving sleep and reducing nighttime urination in older adults
Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT)
This study is testing a new combined treatment to see if it can help older adults sleep better and reduce nighttime trips to the bathroom.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Atlanta VA Medical Center Federal |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06110091 on ClinicalTrials.gov |
What this trial studies
The Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT) is a randomized trial designed to evaluate the effectiveness of an integrated treatment approach for older adults suffering from both nocturia and insomnia. This study aims to assess how this combined treatment impacts participants' quality of life. Participants will be recruited from various sources, including veterans' databases and sleep clinics, and will undergo weekly visits to monitor their progress. The trial seeks to provide evidence for a shift in treatment strategies for nocturia in older adults.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 60 years or older who experience nocturia at least twice nightly and have insomnia symptoms.
Not a fit: Patients with significant cognitive impairment, untreated sleep-disordered breathing, or other specific sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and reduced nighttime urination for older adults, enhancing their overall quality of life.
How similar studies have performed: Previous studies have indicated the potential benefits of multicomponent behavioral treatments for sleep disorders, suggesting that this approach may yield positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 1 other locations
- VA Greater Los Angeles Healthcare System — Los Angeles, California, United States (Recruiting)
- Atlanta VAHCS — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: E. Camille Vaughan, MD, MS — Atlanta VAMC & Emory University
- Study coordinator: Taressa Sergent
- Email: Taressa.Sergent@va.gov
- Phone: (404) 315-4100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.