Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT01411969
Status:
COMPLETED
Last Update Posted:
2011-08-08
First Post:
2011-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of External Nasal Dilator on the Rhinogram
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015508', 'term': 'Nasal Obstruction'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-05', 'studyFirstSubmitDate': '2011-07-26', 'studyFirstSubmitQcDate': '2011-08-05', 'lastUpdatePostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['external nasal dilator strip', 'nasal valve', 'acoustic rhinometry'], 'conditions': ['Nasal Obstruction']}, 'referencesModule': {'references': [{'pmid': '20109318', 'type': 'RESULT', 'citation': 'Seren E. The effect of an adhesive external nasal dilator strip on the inspiratory nasal airflow. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):e29-31. doi: 10.2500/ajra.2010.24.3426.'}, {'pmid': '22185733', 'type': 'DERIVED', 'citation': 'Nigro CE, Mion O, Mello JF Jr, Voegels RL, Roithmann R. Acoustic rhinometry: impact of external nasal dilator on the two first notches of the rhinogram. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e247-50. doi: 10.2500/ajra.2011.25.3708.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to present new data for a better understanding of the anatomic correlation of these two notches.\n\nThis study included 32 nasal cavities (16 individuals) with external nasal dilator strip (Breath Right®) and after decongestion (0.05% oxymetazoline chloride applied as an aerosol spray);', 'detailedDescription': 'Acoustic rhinometry is more accurate in the anterior portion of the nasal cavities, from the nostril to the nasal valve (NV), the most important site of nasal obstruction. Literature presents different opinions regarding the anatomical correlation of the two notches at the beginning of the rhinogram curve in normal adult Caucasian individuals.\n\nThis prospective study included 32 nasal cavities under the following conditions: 1st - basal condition; 2nd - with external nasal dilator strip (ENDS) (Breath Right®); 3rd - after decongestion (0.05% oxymetazoline chloride applied as an aerosol spray); 4th - after decongestion with ENDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '32 nasal cavities of 16 normal adult Caucasian individuals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult, Caucasian\n\nExclusion Criteria:\n\n* Allergies, sinusitis, nasal polyps, external nasal deformities congenital or acquired, obstructive nasal deviation and regular use of any drug.'}, 'identificationModule': {'nctId': 'NCT01411969', 'acronym': 'ARENDS', 'briefTitle': 'Impact of External Nasal Dilator on the Rhinogram', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Acoustic Rhinometry: Impact of External Nasal Dilator on the Two First Notches of the Rhinogram', 'orgStudyIdInfo': {'id': '306/03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'External nasal dilator, decongestion', 'interventionNames': ['Drug: External Nasal Dilator Strip; 0.05% oxymetazoline chloride']}], 'interventions': [{'name': 'External Nasal Dilator Strip; 0.05% oxymetazoline chloride', 'type': 'DRUG', 'otherNames': ['Breath Right®'], 'description': 'External Nasal Dilator Strip placed above the upper lateral cartilage; 20 minutes after decongestion with 0.05% oxymetazoline chloride applied as an aerosol spray (two times); after decongestion with ENDS.', 'armGroupLabels': ['External nasal dilator, decongestion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3471', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Sao Paulo General Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Joao F Mello-Jr, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Carlos Eduardo Nazareth Nigro, Ph.D', 'oldOrganization': 'University of Sao Paulo General Hospital'}}}}