[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547835":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":67,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":26,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"SleepRes Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"4-weeks breathing on APAP","PLACEBO_COMPARATOR","Patients will breathe on APAP for 4 weeks simulating normal therapy. Usage, leak, P95\u002FP90 and AHI will be recorded and averaged over the duration.",[13],"Device: APAP",{"label":15,"type":16,"description":17,"interventionNames":18},"4-weeks breathing on KPAP","EXPERIMENTAL","Patients will breathe on TheraPAP for 4 weeks, which is the therapy under evaluation. Usage, leak, P95\u002FP90 and AHI will also be recorded and averaged over the duration.",[19],"Device: KPAP",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","KPAP","TheraPAP is a novel CPAP-based therapy in which pressure is dropped as much as 5 cmH2O starting at the beginning of inspiration and extending through the end of expiration where it rises back up to the true therapy pressure for a short period. It improves comfort by providing pressure only when it is needed and maintaining it at a low level the rest of the time. Normal CPAP\u002FAPAP therapy keeps pressure at the therapy level during the entire breath cycle, except with some alternate approaches where pressure is decreased but only during the expiratory phase.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"APAP","Standard CPAP therapy where therapy pressure is automatically adjusted to prevent respiratory events from occurring. The TheraPAP prototype device will be used to operate in the APAP mode in addition to the TheraPAP intervention mode.",[9],[32],{"name":33,"affiliation":34,"role":35},"William H Noah, MD","SleepRes, LLC., Sleep Centers of Middle Tennessee, LLC","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Philip Tallent, MD","CONTACT","615-893-4896","gtallent@sleepcenterinfo.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Bernard Hete, PhD","412-398-2846","bhete@sleepres.com",[47],{"facility":48,"status":26,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Sleep Centers of Middle Tennessee","Murfreesboro","Tennessee","37129","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-86.39027,35.84562,{"lat":58,"lon":57},[61,64,66],{"name":62,"role":39,"phone":40,"phoneExt":26,"email":63},"Craig Salazar","csalazar@sleepcenterinfo.com",{"name":43,"role":65,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":33,"role":65,"phone":26,"phoneExt":26,"email":26},{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100547835","kpap-adherence-crossover-study-100547835",false,"NCT06413134","KPAP Adherence Crossover Study","A Prospective, Randomized, Crossover Study of Therapy Adherence With Kairos Positive Airway Pressure (KPAP) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Obstructive Sleep Apnea (OSA)","Inclusion Criteria:\n\n1. AHI \\> 10 on a previous PSG or HST (hypopneas requiring 4% desaturation).\n2. Central apneas \\\u003C 25% of events\n3. PLM (Periodic Limb Movements) arousal index \\\u003C 15\n\nExclusion Criteria:\n\n1. A female of child-bearing potential that is pregnant or intends to become pregnant.\n2. Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, etc., or at the discretion of the site Principal Investigator (PI).\n3. Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, anticonvulsants, etc.\n4. The presence of any other sleep disorder (insomnia, periodic limb movement disorder, etc).\n5. Prior therapy or treatment for OSA.\n6. Chronic oxygen therapy.\n7. Excessive alcohol consumption (\\>14 drinks\u002Fweek).\n8. The use of any illegal drug(s).\n9. Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.","ALL","20 Years","80 Years",{"count":80,"type":81},30,"ESTIMATED","INTERVENTIONAL",[84],"NA","A device able to provide less positive airway pressure (PAP) for the entire duration of inspiration and roughly half the duration of expiration, designated KPAP, is being developed by SleepRes for the treatment of obstructive sleep apnea (OSA). In prior studies, the administration of higher inspiratory than expiratory PAP did not substantially increase treatment efficacy or adherence to continuous PAP (CPAP), which remains low. In our recent investigation, we demonstrated that the addition of a resistor to the CPAP circuit to reduce inspiratory PAP increased subjective comfort. In another study, we showed that KPAP improved subjective comfort during wakefulness vs. fixed CPAP, while maintaining treatment efficacy. The present study, KPAP Adherence 1, is a randomized, crossover study designed to examine whether KPAP can improve adherence over APAP as an at home treatment for OSA.",[87],"Obstructive Sleep Apnea","NOT_YET_RECRUITING","2026-05-04",{"date":91,"type":92},"2026-05-06","ACTUAL",{"date":94,"type":81},"2026-07-01",{"date":96,"type":81},"2026-12-31",{"name":5,"class":6},1]