[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523090":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":37,"centralContacts":45,"locations":53,"responsibleParty":71,"collaborators":32,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":32,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":32,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":32,"overallStatus":55,"whyStopped":32,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Dynamic CO2 within Drive-Dependent OSA","EXPERIMENTAL","During sleep, before \\~30 distinct respiratory events, we will administer \\~2% CO2 for \\~3-4 breaths.",[13],"Other: Dynamic CO2",{"label":15,"type":16,"description":11,"interventionNames":17},"Dynamic CO2 within Classic OSA","ACTIVE_COMPARATOR",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Sham CO2 within Drive-Dependent OSA","SHAM_COMPARATOR","During sleep, Sham CO2 (air) will be administered for \\~3-4 breaths before respiratory events.",[23],"Other: Sham CO2",{"label":25,"type":20,"description":21,"interventionNames":26},"Sham CO2 within Classic OSA",[23],[28,33],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Dynamic CO2","2% inspired CO2 for 2-4 breaths",[15,9],null,{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Sham CO2","Air",[25,19],[38,42],{"name":39,"affiliation":40,"role":41},"Scott Sands, PhD","Brigham and Women's Hospital and Harvard Medical School","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":40,"role":44},"Dillon Gilbertson","STUDY_DIRECTOR",[46,50],{"name":39,"role":47,"phone":48,"phoneExt":32,"email":49},"CONTACT","8579280341","sasands@bwh.harvard.edu",{"name":51,"role":47,"phone":32,"phoneExt":32,"email":52},"Atqiya Aishah, PhD","aaishah@bwh.harvard.edu",[54],{"facility":5,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-71.05977,42.35843,{"lat":65,"lon":64},[68],{"name":69,"role":47,"phone":32,"phoneExt":32,"email":70},"Scott SANDS, PhD","sasands@partners.org",{"type":41,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Scott Aaron Sands","Assistant Professor","100523090","reversible-effect-of-falling-ventilatory-drive-in-drive-dependent-osa-100523090",false,"NCT06091098","Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA","Inclusion Criteria:\n\n* Diagnosed OSA (AHI≥15 events\u002Fh reported in a PSG performed within 1 year) or Suspected OSA (snoring, sleepiness, witnessed apneas, other clinical symptoms)\n* Use of CPAP or other therapies is acceptable; individuals will be asked to withhold treatment for 3 days before each study visit. Individuals who are occupational drivers or operate heavy machinery will not be asked to withhold treatment.\n\nExclusion Criteria:\n\n* Any unstable medical conditions\n* Conditions that could meaningfully raise the cardiovascular risks of brief low-dose hypercapnic-hypoxic inspired gas mixture: heart failure (LVEF\\\u003C45% if known), recent cardiovascular event (\\\u003C12 mo), recent cerebrovascular event (\\\u003C12 mo)\\*\n* Medications known to depress ventilatory drive (e.g. opioids, barbiturates)\n* Conditions likely to increase arousability from sleep: insomnia\n* Other sleep disorders that may complicate establishment of sleep: periodic limb movements (periodic limb movement arousal index \\> 10\u002Fhr), narcolepsy, or parasomnias\n* For intramuscular electrodes and catheter: allergy to lidocaine\n* Highly-sensitive gag reflex. Patients with a self-reported 'highly-sensitive gag reflex', including an affirmative response to 'Do you sometimes gag when brushing your teeth?', will not take part in the physiology studies given the placement of an esophageal catheter\n* For intramuscular electrodes: use of aspirin or other oral anti-platelets \u002F anti-coagulants\n* For oronasal mask: severe claustrophobia\n* Pregnancy or nursing\n\n  * We do not intend to exclude patients with controlled cardiovascular disease (hypertension of any severity, arrhythmias, stents) common in the OSA patient population. The transient gas mixture interventions are mild, short-lived, and act to slow the spontaneous recovery of blood gas levels to prevent cyclic upper airway obstruction as opposed to exacerbating them. Control of breathing studies commonly increase inspired CO2\u002Freduce inspired oxygen (using higher concentrations via rebreathing tests for longer durations) in patients with a range of comorbidities including heart failure. The level of hypercapnic-hypoxia used is equivalent to taking slightly smaller breaths (by about a third, for the standard dose gas mixture 2%CO2\u002F18.5%O2) for several breaths, or skipping a breath (for the highest dose gas mixture 6%CO2\u002F14%O2), physiological changes that typically cause no noticeable oxygen desaturation, and are minimal compared with the effects of the larger ventilation reduction that accompanies OSA.","ALL","21 Years","80 Years",{"count":84,"type":85},36,"ESTIMATED","INTERVENTIONAL",[88],"NA","Obstructive sleep apnea (OSA) is a highly prevalent disorder that has major consequences for cardiovascular health, neurocognitive function, risk of traffic accidents, daytime sleepiness, and quality of life. For years, a \"classic\" model of OSA has been used to describe the disorder, which fails to capture it's complexity. Recently, a model for OSA called drive-dependent OSA was discovered be more prevalent in the OSA population. The drive-dependent subgroup benefits exclusively from increased ventilation, increased dilator muscle activity, and reduced event risk when drive spontaneously rises. This study seeks to provide direct evidence that reducing the loss of drive prevents the loss of ventilation, pharyngeal muscle activity, and thus the onset of OSA respiratory events, specifically in \"drive-dependent\" but not \"classic\" OSA. This will be achieved using CO2 delivered at precise times during breaths in sleep to prevent loss of overall ventilatory drive.",[91],"OSA","2025-03-17",{"date":94,"type":95},"2025-03-19","ACTUAL",{"date":97,"type":95},"2024-03-27",{"date":99,"type":85},"2027-12-31",{"name":5,"class":6},1]