[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100293854":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":29,"locations":38,"responsibleParty":52,"collaborators":29,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":29,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":29,"enrollmentInfo":64,"targetDuration":29,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":77,"whyStopped":29,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"All participants (Baseline phase)","EXPERIMENTAL","All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1.",[13],"Device: Prototype nasal dilator strip",{"label":15,"type":10,"description":16,"interventionNames":17},"All Participants (Active Phase)","All the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8) and 28 days (Day 29) of treatment",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"All Participants (Nasal Resistance Phase)","The participants were randomized to receive a sequence of either 'strip'\u002F' no strip' or 'no strip'\u002F'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule",[13,22],"Other: No strip",[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Prototype nasal dilator strip","External Prototype Nasal Dilator strip. GSK prototype nasal dilator AB 2R11. All the participants used nasal dilator strip throughout the active phase of the study (Day 1 to Day 28). Followed by that all the participants used the nasal strip on Day 29 or 30 in Nasal resistance phase of the study as per their randomization sequence.",[15,19,9],null,{"type":31,"name":32,"description":29,"armGroupLabels":33,"otherNames":29},"OTHER","No strip",[19],[35],{"name":36,"affiliation":5,"role":37},"GSK Clinical Trials","STUDY_DIRECTOR",[39],{"facility":40,"status":29,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":29},"Westmead Hospital","Westmead","New South Wales","2145","Australia","AU",{"type":47,"coordinates":48},"Point",[49,50],150.98768,-33.80383,{"lat":50,"lon":49},{"type":53,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100293854","phase-2-to-characterize-the-performance-of-the-nasal-dilator-strip-in-lowering-nasal-resistance-during-sleep-promoting-nasal-route-breathing-and-reducing-the-signs-and-symptoms-of-sleep-disordered-breathing-in-a-group-of-chronic-nocturnal-nasal-congestion-sufferers-who-report-trouble-with-their-sleep-100293854",true,"NCT03105297","To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.","An Exploratory Study of a Nasal Dilator Strip","Inclusion Criteria:\n\n* Nostril types I and II (Inter-axial angle below 41 degrees = type I; inter-axial angle from 41 to 70 degrees = type II)\n* Nasal Congestion: Have chronic nocturnal nasal congestion ('always or almost always') for at least the last year.\n* Sleep: Reports trouble with sleep\n\nExclusion Criteria:\n\n* Allergy\u002FIntolerance: Known or suspected intolerance or hypersensitivity to latex. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), allergy or atopic reaction to adhesive bandages or latex.\n* Subject has a chronic skin condition or eczema on the face or nose.\n* Subject has visible open sores, sunburn, irritation on the face or nose immediately prior to treatment.\n* Subject has severe obstructive sleep apnea\u002Fhypopnea syndrome with an AHI score \\\u003C30 events\u002Fhour at the Baseline visit.\n* Subject has had a diagnosis of another major sleep disorder (i.e. primary insomnia, i.e. regularly sleeping less than 6 hours per night, sleep insufficiency, i.e. sleeping \\>2 hours more on non-work days as compared to work days, narcolepsy, or periodic limb movement disorder).\n* Subject has a non-typical sleep schedule (e.g. shift-work).\n* Subject plans travel involving time-zone changes during the study period.\n* Subject takes medication known to have a significant effect on sleep. Use of any substance with psychotropic effects or properties known to affect sleep\u002Fwake, including but not limited to: neuroleptics, morphine\u002Fopioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, barbiturates, anxiolytics, thalidomide, hypnotics and sedatives. Use of over the counter sleep promoting agents including diphenhydramine, doxylamine, tryptophan, valerian root, kava kava, melatonin, St John's Wort and Alluna. Use of over the counter alertness aids including caffeine and guarana.\n* Subject currently uses any topical nasal decongestants (nasal sprays, drops, etc). Subject must have discontinued use of topical decongestants at least 7 days prior Baseline.\n* Subject is experiencing an acute upper respiratory tract infection at during qualification phase and at Baseline visit.\n* Subject abuses alcohol (regularly drinks more than 3 drinks per day) or has a recent history (within last 2 years) of substance or alcohol abuse. Regular consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day.\n* Subject has a positive drug of abuse screening result.\n* Subject has severe, unstable disease states (e.g. myocardial infarction, congestive heart failure, diabetes, cirrhosis, cancer, epilepsy, or stroke), pain syndromes, (e.g. fibromyalgia) or any medical or surgical condition that places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study or who in the judgement of the principal investigator would not be suitable for entry into this study.\n* Severe nasal obstruction caused by structural abnormality that renders the subject unsuitable for the study in the opinion of the investigator, i.e. nasal polyps, severe deviated septum.\n* Subject is unwilling to be videotaped or recorded during the PSG studies.\n* Current Treatment for Sleep Disordered Breathing a) Subject currently uses devices prescribed for sleep disordered breathing including Continuous Positive Airway Pressure (CPAP), mandibular advancement devices, tongue displacement devices. b)Over-the-counter products such as chin straps, pillows, internal\u002Fexternal nasal dilators are acceptable provided usage is discontinued at least 28 days prior to Baseline.",false,"ALL","18 Years",{"count":65,"type":66},91,"ACTUAL","INTERVENTIONAL",[69],"PHASE2","To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep.",[72,73],"Sleep Disordered Breathing","Congestion, Nasal",[75,76],"Nasal dilator strip","Sleep disordered breathing","COMPLETED","2019-05-24",{"date":80,"type":66},"2019-07-26",{"date":82,"type":66},"2009-09-25",{"date":84,"type":66},"2010-08-10",{"name":5,"class":6},1]