[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524542":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":45,"responsibleParty":85,"collaborators":88,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":25,"enrollmentInfo":109,"targetDuration":25,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":25,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Atlanta VA Medical Center","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Integrated Behavioral Therapy Program","EXPERIMENTAL","Integrated Behavioral Therapy consists of 5 weekly one-hour sessions (face-to-face either through video or in-person) + 2 telephone check-in with an interventionist. This program integrates cognitive-behavioral treatment for nocturia and insomnia. Brief telephone check-ins will be comprised of review of topics discussed during the sessions.",[13],"Behavioral: Integrated Behavioral Therapy Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Health Education Program","PLACEBO_COMPARATOR","The Health Education Program consists of 5 weekly one-hour sessions (face-to-face either through video or in-person) + 2 telephone check-in with an interventionist. The program modules focus on brain health and includes topics such physical activity, social engagement, sleep topics (e.g., changes in sleep that occur with aging, effects of poor sleep on health), medications\u002Fmedical conditions, vision and hearing impairment. Brief telephone check-ins will be comprised of review of health topics discussed during the sessions.",[19],"Behavioral: Health Education Program",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Integrated Behavioral Therapy is a behavioral program that includes education, lifestyle habits management, cognitive, relaxation, and behavioral conditioning for nocturia and insomnia",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Health Education Program modules focus on brain health and includes topics such physical activity, social engagement, sleep topics (e.g., changes in sleep that occur with aging, effects of poor sleep on health), medications\u002Fmedical conditions, vision and hearing impairment.",[15],[30],{"name":31,"affiliation":32,"role":33},"E. Camille Vaughan, MD, MS","Atlanta VAMC & Emory University","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Taressa Sergent","CONTACT","(404) 315-4100","373124","Taressa.Sergent@va.gov",{"name":42,"role":37,"phone":38,"phoneExt":43,"email":44},"Patric Campbell","373116","Patric.Campbell@va.gov",[46,68],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"VA Greater Los Angeles Healthcare System","RECRUITING","Los Angeles","California","91343","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-118.24368,34.05223,{"lat":58,"lon":57},[61,66],{"name":62,"role":37,"phone":63,"phoneExt":64,"email":65},"Erin E Der-Mcleod","818-891-7711","36067","Erin.Der-mcleod@va.gov",{"name":67,"role":33,"phone":25,"phoneExt":25,"email":25},"Constance H Fung, MD, MSHS",{"facility":69,"status":48,"city":70,"state":71,"zip":72,"country":52,"countryCode":53,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Atlanta VAHCS","Atlanta","Georgia","30033",{"type":55,"coordinates":74},[75,76],-84.38798,33.749,{"lat":76,"lon":75},[79,84],{"name":80,"role":37,"phone":81,"phoneExt":82,"email":83},"E Camille Vaughan, MD, MS","404 315 4100","373100","elizabeth.vaughan2@va.gov",{"name":36,"role":37,"phone":81,"phoneExt":39,"email":40},{"type":33,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Elizabeth Camille Vaughan","Principal Investigator",[89,90,93,95,97],{"name":47,"class":6},{"name":91,"class":92},"Emory University","OTHER",{"name":94,"class":92},"University of California, Los Angeles",{"name":96,"class":92},"University of California, San Francisco",{"name":98,"class":92},"University of Alabama at Birmingham","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":110,"type":111},192,"ESTIMATED","INTERVENTIONAL",[114],"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.",[117,118],"Nocturia","Insomnia","2025-09-29",{"date":121,"type":122},"2025-09-30","ACTUAL",{"date":124,"type":122},"2023-12-05",{"date":126,"type":111},"2028-08",{"name":5,"class":6},2]