[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Atlanta VA Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100524542","multi-center-trial-to-improve-nocturia-and-sleep-in-older-adults-100524542",false,"NCT06110091","Multi-center Trial to Improve Nocturia and Sleep in Older Adults","Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT)","MINT","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Average of ≥ 2 episodes per night of nocturia on the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB) questionnaire\n* Insomnia Severity Index \\> 7\n* Able to attend weekly study visits\n\nExclusion Criteria:\n\n* Prior cognitive behavioral therapy for insomnia\n* Presence of bipolar disorder\n* Significant cognitive impairment as measured by a score \\\u003C 20 on the Mini-Mental State Exam\n* Sleep disturbance better explained by another sleep disorder such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders\n* 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)\n* Current urinary tract infection or hematuria\n* Unstable doses or recent changes in bladder medication\n* New or recently discontinued insomnia medication within past month\n* Previous or current intensive behavioral therapy for insomnia or urinary symptoms,\n* Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by overall study PIs or Site PI.\n* 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\n* Unstable psychiatric conditions (e.g., psychosis, active alcohol\u002Fsubstance abuse based on history and medical records)\n* Unstable housing situation\n* Evidence of significant urinary retention as measured by a residual bladder volume of ≥ 200 mL by bladder ultrasound with 15 minutes of voiding\n* Genitourinary cancer undergoing active treatment\n* Pelvic or colon surgery within 6 months of enrollment or onabotulinum toxin therapy for urinary symptoms within 6 months of enrollment","ALL","60 Years",{"count":20,"type":21},192,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28],"Nocturia","Insomnia","RECRUITING","2025-09-29",{"date":32,"type":33},"2025-09-30","ACTUAL",{"date":35,"type":33},"2023-12-05",{"date":37,"type":21},"2028-08",{"name":39,"class":40},"Atlanta VA Medical Center","FED",2,""]