[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607297":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":40,"locations":47,"responsibleParty":64,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":45,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":45,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":49,"whyStopped":45,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Kentucky","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Panthera DSAD mandibular advancement device users","EXPERIMENTAL","Participants of the study that have been referred to the Orofacial Pain Clinic by their sleep physician for the management of their obstructive sleep apnea with a mandibular advancement device.",[13,14,15],"Device: Under-mattress monitor","Device: level 3 Home Sleep Apnea Test","Device: Mandibular Advancement Device (MAD)",[17,24,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","Under-mattress monitor","the under-mattress monitor will be used in conjunction with the Alice NightOne at the beginning and end of the study, in addition, the under-mattress monitor will be used daily during sleep with the intraoral device in situ",[9],[23],"Sleeptracker-AI",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"level 3 Home Sleep Apnea Test","Home sleep apnea test with Alice NightOne will be used for one day during sleep at the beginning and end of the study in conjunction with the Sleeptracker AI and the intraoral device.",[9],[29],"Alice NightOne",{"type":18,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Mandibular Advancement Device (MAD)","CAD-CAM, US Food and Drug Administration (FDA)-approved MAD, duo-bloc, customized, titratable sleep appliance. Participants will return every 2 weeks to the Orofacial Pain (OFP) clinic to progressively titrate the MAD advancement as needed until the under-mattress monitor scores an AHI \\\u003C 5",[9],[35],"D-SADTM Panthera Dental",[37],{"name":38,"affiliation":5,"role":39},"Isabel Moreno Hay, DDS, PhD","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Sumia Alyousef, BDS","CONTACT","(859) 323-3440",null,"Sumia.Alyousef@uky.edu",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Lexington","Kentucky","40506","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-84.47772,37.98869,{"lat":59,"lon":58},[62],{"name":42,"role":43,"phone":63,"phoneExt":45,"email":46},"8593235500",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"SPONSOR_INVESTIGATOR","Isabel Moreno Hay","Associate Professor",[69],{"name":70,"class":71},"American Academy of Dental Sleep Medicine","UNKNOWN","100607297","home-based-under-mattress-monitor-for-osa-100607297",false,"NCT07186725","Home-based Under Mattress Monitor for OSA","Home-Based Under-Mattress Monitoring Device to Estimate Mandibular Advancement in Oral Appliance Therapy for Obstructive Sleep Apnea","Inclusion Criteria:\n\n* Diagnosis of Obstructive Sleep Apnea demonstrated with a sleep study polysomnography or home sleep study (PSG or HSAT), manually scored by a sleep physician according to the 2017 American Academy of Sleep medicine scoring guidelines.\n* Willingness to commute to the OFP clinic every 2 weeks during MAD titration period.\n* Consent to partake in the study.\n\nExclusion Criteria:\n\n* Diagnosis of central or mixed sleep apnea.\n* Neurocognitive disease.\n* Concomitant therapy with PAP therapy.\n* Allergic to the appliance material (Polyamide 12).\n* Presence of active dental decay, ill-fitting dental restorations, or crown to root ratio unfavorable.\n* Inadequate English language comprehension.\n* Lack of coordination or dexterity to insert\u002Fremove the MAD intraorally.\n* Inability to tolerate digital dental impressions.\n* Patients with concomitant diagnosed sleep disorders, including narcolepsy, restless leg syndrome, rapid eye movement sleep behavior disorder).","ALL","18 Years","80 Years",{"count":83,"type":84},70,"ESTIMATED","INTERVENTIONAL",[87],"NA","The aim of the study is to evaluate the effectiveness of the under-mattress monitoring device to aid in the titration process of a mandibular advancement device (MAD) for the management of obstructive sleep apnea (OSA). A secondary aim is to evaluate changes in subjective OSA symptoms and patient's satisfaction with MAD. A third aim is to analyze if there are differences between the sleep parameters recorded by the under-mattress monitor between responders and non-responders to MAD therapy.",[90,91],"Obstructive Sleep Apnea (OSAS)","Obstructive Sleep Apnea (SAOS)",[93,94,95,96,97,98],"Mandibular Advancement","Sleep Apnea","Oral Appliance","Home-based","Obstructive Sleep Apnea","Home-based device","2026-02-02",{"date":101,"type":102},"2026-02-03","ACTUAL",{"date":104,"type":102},"2026-01-07",{"date":106,"type":84},"2027-03",{"name":66,"class":6},1]