[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619829":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":51,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Florida State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High-Resistance","EXPERIMENTAL","Participants assigned to the high resistance arm will complete inspiratory muscle strength training (IMST) using a handheld respiratory training device set to 75% of their maximal inspiratory pressure (MIP). Participants will follow the IMST training regimen for the duration of the intervention period, 8-weeks, consisting of 30 breaths per day, completed in a minimum of 5 minutes.",[13],"Device: Inspiratory Muscle Strength Training High-Resistance",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group - Low-Resistance","SHAM_COMPARATOR","Participants assigned to the low-resistance arm will complete inspiratory muscle strength training (IMST) using a handheld respiratory training device set to 15% of their maximal inspiratory pressure (MIP). Participants will follow the IMST training regimen for the duration of the intervention period, 8-weeks, completing 30 inspiratory breaths per day, with each session lasting a minimum of 5 minutes.",[19],"Device: Inspiratory Muscle Strength Training Low-Resistance",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Inspiratory Muscle Strength Training High-Resistance","Investigators will use POWERbreathe® Electronic IMST devices and manually set them to 75% of an individual's IPpeak, depending on their randomization, to the high-resistance IMST group or very low-resistance IMST (sham) group. All participants will complete 30 training breaths per day at home for 8 weeks.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Inspiratory Muscle Strength Training Low-Resistance","Investigators will use POWERbreathe® Electronic IMST devices and manually set them to 15% of an individual's IPpeak, depending on their randomization, to the high-resistance IMST group or very low-resistance IMST (sham) group. All participants will complete 30 training breaths per day at home for 8 weeks.",[15],[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Tallahassee","Florida","32301","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-84.28073,30.43826,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Dr. Julia Sheffler","CONTACT","850-644-4199","julia.sheffler@med.fsu.edu",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Julia Sheffler","Assistant Professor",[56],{"name":57,"class":58},"National Institutes of Health (NIH)","NIH","100619829","imst-for-dementia-risk-reduction-100619829",false,"NCT07349706","IMST for Dementia Risk Reduction","Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training (IMST) to Reduce Dementia Risk in Older Adults","Inclusion Criteria:\n\n* Ages 60-80\n* Converted telephone MoCA total score≥18\n* Presence of at least one dementia risk factor (e.g., MCI or subjective cognitive decline, hypertension \\[SBP \\>130 mmHg or on medication\\], sedentary lifestyle \\[\\\u003C150 min\u002Fweek\\], family history of dementia or self-reported APOE ε4 carrier, or mild sleep-disordered breathing; CAIDE total score \\[\\>5\\]\n* Capable of independently completing or requiring minimal assistance with inspiratory muscle strength training (IMST)\n* Willing to adhere to the IMST protocol (approximately 5-10 minutes per day for 8 weeks)\n* Optional inclusion of inspiratory muscle weakness (MIP \\\u003C80 cmH₂O for men, \\\u003C70 cmH₂O for women) will also be assessed.\n\nExclusion Criteria:\n\n* tMoCA \\\u003C18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI)\n* Current evidence of any major psychiatric disorder including psychosis (at the discretion of principal investigator), bipolar disorder, severe major depression (PHQ-9 \\> 20)\n* Unstable cardiovascular or pulmonary disease\n* Recent respiratory therapy or major medication changes\n* Self-reported severe untreated or unstable obstructive sleep apnea (OSA)\n* Recent start (within the past month) of CPAP or BiPAP, or recent use of inspiratory muscle training\n* Lung and eardrum injuries\n* Non-English speaking\n* Participants with a pacemaker or other medical implants containing magnets or electronics will be noted and excluded from body composition analyses.","ALL","60 Years","80 Years",{"count":70,"type":71},30,"ESTIMATED","INTERVENTIONAL",[74],"NA","Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical\u002Fmotor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.",[77,78,79,80,81,82,83],"Systolic Blood Pressure","Blood Pressure","Depression - Major Depressive Disorder","Anxiety","Sleep Quality","Physical Function","Cognitive Function","2026-03-24",{"date":86,"type":87},"2026-03-27","ACTUAL",{"date":89,"type":87},"2025-11-17",{"date":91,"type":71},"2026-12",{"name":5,"class":6},1]