[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503579":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":130,"collaborators":31,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":31,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":31,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":31,"overallStatus":58,"whyStopped":31,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Soduim Oxybate for Idiopathic Hypersomnia","EXPERIMENTAL","Subjects prescribed with low sodium oxybate for idopathic hypersomnia will have a 24-hour polysomnography, wear an Axivity wristband and Nextsense EEG earbuds to evaluate total sleep time.",[13,14,15,16],"Drug: Low Sodium Oxybate","Diagnostic Test: 24-hour polysomnography","Device: Nextsense EEG earbuds","Device: Axivity device",[18,26,32,37],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Low Sodium Oxybate","Titrated according to standard of care and continued on stable dose for 3 months",[9],[24,25],"Xywav","Calcium, Magnesium, Potassium, and Sodium Oxybates",{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIAGNOSTIC_TEST","24-hour polysomnography","Performed in a sleep study lab, recording of body functions including brain activity, eye movements, muscle activity, heart rhythm and blood oxygen levels while asleep and awake for a 24-hour period",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DEVICE","Nextsense EEG earbuds","Ear buds used to record sleep staging worn for a 24-hours period",[9],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Axivity device","Wristband that records activity level worn for approximately one month to track sleep and steps\u002Factivity.",[9],[42],{"name":43,"affiliation":5,"role":44},"Chad Ruoff, MD","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Gabbi Montefiore","CONTACT","(480)574-1288","montefiore.gabrielle@mayo.edu",{"name":52,"role":48,"phone":53,"phoneExt":31,"email":54},"Arleth Valencia","(480)342-6487","Valencia.Arleth@mayo.edu",[56,76,96,113],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Mayo Clinic Arizona","RECRUITING","Phoenix","Arizona","85054","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-112.07404,33.44838,{"lat":68,"lon":67},[71,75],{"name":72,"role":48,"phone":73,"phoneExt":31,"email":74},"Lupe (Ray) Canez","(480) 574-2753","Canez.Lupe@mayo.edu",{"name":43,"role":44,"phone":31,"phoneExt":31,"email":31},{"facility":77,"status":58,"city":78,"state":79,"zip":80,"country":62,"countryCode":63,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Stanford University","Redwood City","California","94063",{"type":65,"coordinates":82},[83,84],-122.23635,37.48522,{"lat":84,"lon":83},[87,91,93],{"name":88,"role":48,"phone":89,"phoneExt":31,"email":90},"Miran Cho","(650)503-3489","mirancho@stanford.edu",{"name":92,"role":44,"phone":31,"phoneExt":31,"email":31},"Emmanuel Mignot, MD",{"name":94,"role":95,"phone":31,"phoneExt":31,"email":31},"Oliver Sum-Ping, MD","SUB_INVESTIGATOR",{"facility":97,"status":58,"city":98,"state":99,"zip":100,"country":62,"countryCode":63,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Mayo Clinic Florida","Jacksonville","Florida","32224",{"type":65,"coordinates":102},[103,104],-81.65565,30.33218,{"lat":104,"lon":103},[107,111],{"name":108,"role":48,"phone":109,"phoneExt":31,"email":110},"Wesley Dillinger","(904)953-3626","dillinger.wesley@mayo.edu",{"name":112,"role":44,"phone":31,"phoneExt":31,"email":31},"Joseph Cheung, MD",{"facility":114,"status":58,"city":115,"state":116,"zip":117,"country":62,"countryCode":63,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"type":65,"coordinates":119},[120,121],-71.05977,42.35843,{"lat":121,"lon":120},[124,128],{"name":125,"role":48,"phone":126,"phoneExt":31,"email":127},"Phoebe Aney","(617) 975-7568","paney@bidmc.harvard.edu",{"name":129,"role":44,"phone":31,"phoneExt":31,"email":31},"Robert Thomas, MD",{"type":44,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Chad M. Ruoff","Principal Investigator","100503579","phase-4-low-sodium-oxybate-in-patients-with-idiopathic-hypersomnia-100503579",false,"NCT05837091","Low Sodium Oxybate in Patients With Idiopathic Hypersomnia","Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia","Inclusion Criteria:\n\n1. Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT)\n2. Subjects aged 18 - 65 years\n3. BMI between 18 and 35 kg\u002Fm2\n4. Self-reported sleep duration ≥ 9 hours most days including daytime naps\u002Fsleep based upon at least 10\u002F14 days of completed sleep diary entries\n5. Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only)\n6. Recommended LSO by a clinical sleep specialist as part of routine medical care. The clinical sleep specialist will be responsible for titrating LSO according to standard of care.\n7. Subject must be willing to postpone LSO therapy until all baseline assessments completed\n8. If treated with wake promoting agents, traditional stimulants and\u002For antidepressant(s), a stable dose and regimen will be required for at least 2 months before study entry and throughout the main study\n9. Have used a medically acceptable method of contraception for at least 2 full menstrual cycles before participating in this study and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 30 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Succinic semialdehyde dehydrogenase deficiency, porphyria\n2. Other central nervous system diseases: neurodegenerative diseases, , seizure disorders or history of head trauma associated with loss of consciousness\n3. Lifetime history of suicide attempt or suicidal ideation in the past six months, including answer to question #9 on PHQ-9 ≥1; PHQ-9 total score \\> 10; prior history of psychotic episodes; active major depressive disorder\n4. Change to psychiatric medication(s)\u002Fstimulant(s) within last 3 months\n5. History of chronic alcohol or drug abuse within the prior 12 months\n6. Malignant neoplastic disease requiring therapy within the prior 12 months\n7. Heart failure, severe hypertension or other cardiovascular disease compromising the patient's well-being or ability to participate in this study\n8. Renal or hepatic impairment\n9. Compromised respiratory function (e.g., history of COPD, pulmonary hypertension, and\u002For poorly controlled asthma)\n10. Diagnosis of sleep-related breathing disorders (AHI ≥ 15 events\u002Fh using 4 % AHI) or high suspicion for sleep disordered breathing\n11. Any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.)\n12. No regular sleep at night: shift work or other continuous, non-disease-related life conditions\n13. Participation in another study of an investigational drug within the 28 days prior to Screening visit or currently\n14. Pregnant and\u002For breast-feeding\n15. Ear jewelry and\u002For piercings that subject not willing to\u002Funable to remove\n16. Use of device\u002Fimplant that may interfere with the study devices\u002Fprocedures (e.g., vagal nerve stimulator)\n17. Smoke and\u002For use of smokeless tobacco products\n18. Subjects who, in the opinion of the investigator(s), may not be suitable for the study","ALL","18 Years","65 Years",{"count":144,"type":145},30,"ESTIMATED","INTERVENTIONAL",[148],"PHASE4","Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. In addition, this study will use novel tools to determine when an individual is awake or asleep.",[151],"Idiopathic Hypersomnia","2026-05-08",{"date":154,"type":155},"2026-05-12","ACTUAL",{"date":157,"type":155},"2024-02-14",{"date":159,"type":145},"2027-06",{"name":5,"class":6},4]