NCT06110091 Multi-center Trial to Improve Nocturia and Sleep in Older Adults
| NCT ID | NCT06110091 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Atlanta VA Medical Center |
| Condition | Nocturia |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2023-12-05 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2023-12-05 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
E. Camille Vaughan, MD, MS
PRINCIPAL INVESTIGATOR
Atlanta VAMC & Emory University
Frequently Asked Questions
Who can join the NCT06110091 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Nocturia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06110091 currently recruiting?
Yes, NCT06110091 is actively recruiting participants. Contact the research team at Taressa.Sergent@va.gov for enrollment information.
Where is the NCT06110091 trial being conducted?
This trial is being conducted at Los Angeles, United States, Atlanta, United States.
Who is sponsoring the NCT06110091 clinical trial?
NCT06110091 is sponsored by Atlanta VA Medical Center. The principal investigator is E. Camille Vaughan, MD, MS at Atlanta VAMC & Emory University. The trial plans to enroll 192 participants.