[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658918":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":38,"interventions":53,"overallOfficials":58,"centralContacts":62,"locations":68,"responsibleParty":119,"collaborators":121,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":27,"eligibilityCriteria":132,"healthyVolunteers":129,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":27,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":152,"whyStopped":27,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"University of Virginia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Improvement in Odor Perception","The investigators will use a highly-validated psychophysical smell test (the Sniffin' Sticks Extended Test) to assess changes in olfactory perception and their duration. This test is the primary outcome measure. The resulting TDI score reflects performance on three related test components that measure odor detection Threshold, odor Discrimination, and odor Identification. The scale is 0-48, with higher scores indicating greater function. Investigators will also administer another highly-validated psychophysical smell test, the University of Pennsylvania Smell Identification Test (UPSIT). The score on this 40 point test will not be used to determine the primary outcome but will allow direct comparisons to some other studies that used this measure (higher scores indicated greater function).","From enrollment to the end-of-study visit at 52 weeks",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Improvement in social and emotional loneliness","Patients with smell loss often experience negative changes in mental health, including increased loneliness. The investigators will use the well-validated De Jong Gierveld short scale questionnaire, composed of six questions, to assess changes in the levels of emotional and social loneliness for each participant. Higher scores on the six-point scale indicates greater loneliness.",{"measure":18,"description":19,"timeFrame":12},"Improvement in quality of life","Patients with smell loss often experience negative changes in their quality of life. To assess changes in health-related quality of life, the investigators will administer the SF-12v2 Health Survey questionnaire (or alternatively the Child Health Questionnaire for participants younger than 18 years old). The SF12v2 provides summary, norm-based scores for mental and physical components, with scores of 50 corresponding to the US population average. Higher scores indicate better health-related quality of life.",{"measure":21,"description":22,"timeFrame":12},"Changes in olfactory-associated quality of life","Patients with smell loss often experience negative changes in their quality of life. To assess changes in quality of life aspects that have been previously shown to be correlated with olfactory function, the investigators will administer the olfactory-salient Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS). Higher scores on this 51 point scale indicate a greater negative impact of olfactory dysfunction on quality of life.",{"measure":24,"description":25,"timeFrame":26},"Changes in cognitive function","Several studies have suggested that smell training can improve cognitive function. The investigators will administer the Montreal Cognitive Assessment (MoCA) to measure changes in multiple domains of cognitive function in study participants. The MoCA will only be administered to participants ages 14 years old and up. Higher scores on this 30 point scale indicate better cognitive performance.","From enrollment to the end-of-study visit at 52 weeks.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":34},"TRIPLE",[35,36,37],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[39,45,49],{"label":40,"type":41,"description":42,"interventionNames":43},"Arm 1: Sniffing named odors","ACTIVE_COMPARATOR","Participants randomly assigned to Arm 1 will receive sniff training kits containing four inhaler cartridges, with each cartridge containing a different odor (such as lemon, leather, rose, banana, etc). Odor names will be on the cartridges. Participants are instructed to sniff each inhaler cartridge in the morning and evening for 12 weeks. After this initial 12 weeks, participants will receive a new kit which may contain four different odors. These new inhaler cartridges will be sniffed for an additional 12 weeks. At several points in the study, participants will take smell tests or answer questionnaires to assess their ability to smell, their quality of life, and their psychological and neurological health.",[44],"Other: Sniff Training Kits",{"label":46,"type":41,"description":47,"interventionNames":48},"Arm 2: Sniffing unnamed odors","Arm 2 will be identical to Arm 1 with the exception that the inhaler cartridges provided to participants randomly assigned to Arm 2 will not have labels identifying the aroma contained in each cartridge.",[44],{"label":50,"type":6,"description":51,"interventionNames":52},"Arm 3: Control Arm","Arm 3 will be identical to Arm 2 with the exception that the inhaler cartridges will not contain the same amount of odor as in the inhaler cartridges used in Arm 2.",[44],[54],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":27},"Sniff Training Kits","This study will test the ability of a structured smell training protocol (called \"sniff training\") to improved smell function. Participants will be asked to sniff inhaler cartridges containing different USDA GRAS (generally recognized as safe) odors (such as lemon, leather, strawberry, banana, etc). The amount of odor may differ, and odors may or may not be identified on the inhalers. The inhaler cartridge are provided at no charge to study participants in kits that contain four inhalers each.",[40,46,50],[59],{"name":60,"affiliation":5,"role":61},"Steven Munger","PRINCIPAL_INVESTIGATOR",[63],{"name":64,"role":65,"phone":66,"phoneExt":27,"email":67},"Nino McHedlishvili","CONTACT","434-243-3643","nm6s@virginia.edu",[69,88,104],{"facility":70,"status":27,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Johns Hopkins University","Baltimore","Maryland","21218","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-76.61219,39.29038,{"lat":80,"lon":79},[83,87],{"name":84,"role":65,"phone":85,"phoneExt":27,"email":86},"Nicholas Rowan","443-997-6467","nrowan1@jhmi.edu",{"name":84,"role":61,"phone":27,"phoneExt":27,"email":27},{"facility":89,"status":27,"city":90,"state":91,"zip":92,"country":74,"countryCode":75,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":77,"coordinates":94},[95,96],-79.93275,32.77632,{"lat":96,"lon":95},[99,103],{"name":100,"role":65,"phone":101,"phoneExt":27,"email":102},"Rodney Schlosser","843-792-2300","schlossr@musc.edu",{"name":100,"role":61,"phone":27,"phoneExt":27,"email":27},{"facility":5,"status":27,"city":105,"state":106,"zip":107,"country":74,"countryCode":75,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Charlottesville","Virginia","22903",{"type":77,"coordinates":109},[110,111],-78.47668,38.02931,{"lat":111,"lon":110},[114,118],{"name":115,"role":65,"phone":116,"phoneExt":27,"email":117},"Mackenzie Koch","434-531-5354","mk2nu@uvahealth.org",{"name":60,"role":61,"phone":27,"phoneExt":27,"email":27},{"type":61,"investigatorFullName":60,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Professor, Otolaryngology-Head & Neck Surgery",[122,125,126],{"name":123,"class":124},"National Institutes of Health (NIH)","NIH",{"name":70,"class":6},{"name":89,"class":6},"100658918","snifftrain-effectiveness-of-sniff-training-in-the-treatment-of-post-viral-anosmia-100658918",false,"NCT07857083","SniffTrain: Effectiveness of Sniff Training in the Treatment of Post-Viral Anosmia","Inclusion Criteria:\n\n* Aged 10 - 60 years old\n* For adults, competent and willing to give informed consent\n* For minors, competent and willing to give assent, with informed consent from the parent-guardian\n* Willing to undergo study procedures\n* Able to follow written and verbal instructions in English\n* Be able to report test\u002Fquestionnaire answers via a computer, tablet, or smartphone interface\n* Have a diagnosis of anosmia or hyposmia resulting from a viral infection of the upper respiratory system, with the time since the initial loss of olfactory function \\> 3 months and \\\u003C 2 years prior\n\nExclusion Criteria:\n\n* Aged less than 10 years old, and greater than 60 years old\n* Prisoners\n* Cognitively impaired individuals\n\n  * Individuals who are deemed to not have the capacity to consent by the study team through observation and direct interaction\n  * Individuals 50-60 years old who score \\\u003C31 on the TICS survey (to rule out potential dementia)\n* Non-English speaking subjects\n* Pregnant or breastfeeding\n* Diseases of the central nervous system (including Alzheimer's disease, multiple sclerosis, Parkinson's disease, Huntington's disease, brain tumors), nasal obstruction (tumors\u002Fpolyps)\n* History of nasal or sinus surgery\n* History of a severe head injury\u002Fconcussion\n* History of chronic sinus infections, allergic rhinitis, and active sinonasal disease\n* History of radiation therapy to the head or neck (ever)\n* Recent chemotherapy (within the last year)\n* History of lung\u002Fpulmonary disease\n* Diagnosis of an olfactory disorder with an etiology other than a viral infection of the upper respiratory system\n* Use of the following medications (used within 3 months of enrollment):\n\n  * Oral corticosteroids\n  * Topical corticosteroids\n  * Biologic agents used in the treatment of nasal\u002Fsinus inflammation (dupilumab, omalizumab, mepolizumab, tezepelumab)\n  * Theophylline nasal spray\n  * Nasal vitamin A\n  * Nasal sodium citrate\n* A time since loss of olfactory function \\\u003C 3 months and \\> 2 years.","ALL","10 Years","60 Years",{"count":137,"type":138},204,"ESTIMATED","INTERVENTIONAL",[141],"NA","The purpose of this study is to learn whether a structured smell training program (called \"sniff training\") can help improve sense of smell and quality of life in people who have experienced a reduced or lost sense of smell following a viral illness (also called post-viral anosmia).",[144,145,146],"Post-viral Anosmia","Anosmia","Hyposmia",[148,149,150,151],"smell","olfaction","odor","sniffing","NOT_YET_RECRUITING","2026-09-30",{"date":155,"type":156},"2026-10-05","ACTUAL",{"date":158,"type":138},"2027-01-05",{"date":160,"type":138},"2031-07-31",{"name":5,"class":6},3]