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

Launched by ATLANTA VA MEDICAL CENTER · Oct 25, 2023

Keywords

ClinConnect Summary

The Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT) is a research study aiming to help older adults who struggle with frequent nighttime urination (nocturia) and trouble sleeping (insomnia). The trial will test a combined treatment approach to see how effectively it can improve these issues and, in turn, enhance the participants' overall quality of life. The study is currently looking for participants aged 60 and older who experience at least two episodes of nocturia each night and have moderate insomnia.

To take part in this trial, participants should be able to attend weekly study visits and meet specific health criteria. Some key eligibility points include having insomnia symptoms and not having certain other medical or psychiatric conditions that could complicate the study. Those who join can expect to receive integrated treatment and be closely monitored for any changes in their sleep and urinary habits. This trial is an important opportunity for older adults seeking relief from these common but disruptive issues.

Gender

ALL

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