[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567987":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":112,"collaborators":116,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":24,"enrollmentInfo":130,"targetDuration":24,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Apollo Neuro Device","EXPERIMENTAL",[12],"Device: Apollo Neuro Device",{"label":14,"type":15,"description":16,"interventionNames":17},"Sham Device","SHAM_COMPARATOR","Study participants will be randomized 1:1 (Apollo Neuro device : Sham device) Devices are identical; however, the sham device will be set to a frequency that has no therapeutic benefits.",[18],"Device: Sham device",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","The Apollo Neuro wearable device is an Apple Watch-sized wearable device that delivers vibration at set frequencies , termed transcutaneous vibratory stimulation, or TVS. These low volume sound waves feel like a soothing touch to the skin (TVS) and activate touch receptors. Apollo is controlled via smartphone and worn on the wrist or ankle. The Apollo is fitted with an adjustable band, made of a durable neoprene material with polyester overlays. Participants are asked to wear it daily for a minimum time period for 6 weeks. Users can choose from different modes of vibration, with some being energizing, others relaxing.",[9],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Sham device","The Apollo Neuro is an Apple Watch-sized wearable device that delivers vibration, termed transcutaneous vibratory stimulation, or TVS. The sham device is identical in appearance to the active intervention, but provides a lower frequency vibration that has no known therapeutic benefit.",[14],[30],{"name":31,"affiliation":5,"role":32},"Robyn T Domsic, MD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Maureen M Laffoon, BS","CONTACT","412-648-7871","laffoonm@pitt.edu",{"name":31,"role":36,"phone":40,"phoneExt":24,"email":41},"412-647-6700","rtd4@pitt.edu",[43,63,79,96],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"DelRicht Research Center","RECRUITING","New Orleans","Louisiana","70115","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-90.07507,29.95465,{"lat":55,"lon":54},[58,61],{"name":59,"role":36,"phone":24,"phoneExt":24,"email":60},"Emily Krambeck","ekrambeck@delricht.com",{"name":62,"role":32,"phone":24,"phoneExt":24,"email":24},"Lesley Saketkoo, MD MPH",{"facility":64,"status":45,"city":65,"state":66,"zip":67,"country":49,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"University of Michigan","Ann Arbor","Michigan","48109",{"type":52,"coordinates":69},[70,71],-83.74088,42.27756,{"lat":71,"lon":70},[74,77],{"name":75,"role":36,"phone":24,"phoneExt":24,"email":76},"Muhammad Hussain","muhammhu@med.umich.edu",{"name":78,"role":32,"phone":24,"phoneExt":24,"email":24},"Dinesh Khanna, MD",{"facility":80,"status":45,"city":81,"state":82,"zip":83,"country":49,"countryCode":50,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"University of Pittsburgh and UPMC Scleroderma Center","Pittsburgh","Pennsylvania","15213",{"type":52,"coordinates":85},[86,87],-79.99589,40.44062,{"lat":87,"lon":86},[90,92,95],{"name":91,"role":36,"phone":37,"phoneExt":24,"email":38},"Maureen Laffoon, BS",{"name":93,"role":36,"phone":40,"phoneExt":24,"email":94},"Bailey Gibson, MPH","BIG36@pitt.edu",{"name":31,"role":32,"phone":24,"phoneExt":24,"email":24},{"facility":97,"status":45,"city":98,"state":99,"zip":100,"country":49,"countryCode":50,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":52,"coordinates":102},[103,104],-86.78444,36.16589,{"lat":104,"lon":103},[107,110],{"name":108,"role":36,"phone":24,"phoneExt":24,"email":109},"Sarah Gleason","sarah.wood@vumc.edu",{"name":111,"role":32,"phone":24,"phoneExt":24,"email":24},"Tracy Frech, MD MS",{"type":113,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Robyn T. Domsic, MD, MPH","Associate Professor of Medicine",[117],{"name":118,"class":119},"United States Department of Defense","FED","100567987","the-apollo-device-in-systemic-sclerosis-for-the-management-of-fatigue-raynaud-phenomenon-and-quality-of-life-100567987",false,"NCT06675344","The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life","A Randomized, Double-blind, Clinical Trial of the Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life (ASScERT-QoL)","ASScERT-QoL","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ability to provide written informed consent,\n3. Diagnosis of SSc, as defined by the 2013 ACR\u002FEULAR classification of SSc64 with a positive ANA\n4. Baseline score ≥55 on the FACIT-Fatigue scale,\n5. Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,\n6. Steady daily doses and any immunosuppressive medication, vasodilators or other medications used to treat pulmonary hypertension, antidepressants and anxiolytic use for 4 weeks prior to baseline\n7. Currently owns and operates an iOS or Android smart phone regularly\n8. Ability to comply with the clinical visits schedule and the study-related procedures.\n\nExclusion Criteria:\n\n1. History of sympathectomy or stellate ganglion block\n2. History of Botox injections to the digits within the last 3 months\n3. Diabetes mellitus\n4. Major surgery within 8 weeks\n5. Hospitalization for any reason within four weeks of the study baseline visit\n6. Active malignancy\n7. Pregnant or breastfeeding women,\n8. End-stage renal disease (estimated glomerular filtration rate \\\u003C 15 mL\u002Fmin\u002F1.73m2) or on dialysis,\n9. Hepatic insufficiency as defined by function worse than Child-Pugh Class B\n10. Medication exclusions:\n\n    1. actively prescribed standing doses of beta-blockers,\n    2. actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.","ALL","18 Years",{"count":131,"type":132},160,"ESTIMATED","INTERVENTIONAL",[135],"NA","The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.",[138],"Systemic Sclerosis (SSc)",[140,141,142],"Scleroderma","Raynaud Phenomenon","fatigue","2026-01-07",{"date":145,"type":146},"2026-01-08","ACTUAL",{"date":148,"type":146},"2025-01-06",{"date":150,"type":132},"2028-09",{"name":114,"class":6},4]