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

Exclusion Criteria16

• 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