Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-28 @ 2:47 PM
Study NCT ID:
NCT01069068
Status:
COMPLETED
Last Update Posted:
2011-12-09
First Post:
2010-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-07', 'studyFirstSubmitDate': '2010-02-16', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure the impact of different horizontal mandibular advancements, achieved through a stepped mouthpiece design, on the size of the upper airways in subjects with and without Obstructive Sleep Apnea (OSA).', 'timeFrame': 'one 60 minute session'}], 'secondaryOutcomes': [{'measure': 'Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth', 'timeFrame': 'one 60 minute session'}, {'measure': 'Measurement of the upper airways through acoustic pharyngometry during slow and deep breathing while the subject uses a stepped mouthpiece. The acoustic pharyngometry measurement will be performed at mid inhalation', 'timeFrame': 'one 60 minute session'}, {'measure': 'Assessment of the most comfortable position when using the stepped mouthpiece during both "tidal" and "slow and deep breathing". The scoring of the "comfortable position" will be performed through a Likert-style questionnaire', 'timeFrame': 'one 60 minute session'}, {'measure': 'The most "comfortable position" established as outlined above will be evaluated for comfort while holding that position for 3 minutes. After the 3 minutes, the subject\'s level of comfort will be re-evaluated through a Likert-style questionnaire', 'timeFrame': 'one 60 minute session'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['To evaluate the effect of advancing Jaw on airway dimension'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design, affect the size of the upper airways in subjects with and without Obstructive Sleep Apnea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be performed as an open investigation including 60 subjects. The 60 subjects will be stratified such that 30 subjects should have been diagnosed with OSA, and 30 subjects should not have been diagnosed with OSA.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must provide written informed consent to participate in the study.\n* Adult male or female subjects over 18 years of age who have or have not been diagnosed with OSA.\n* Subjects claiming no history of OSA should take the Epworth questionnaire and obtain a result less than 10.\n* Subjects must satisfy the study investigator about their fitness to participate in the study.\n* Subjects must be available to complete the study.\n\nExclusion Criteria:\n\n* Subjects not compliant with the instructions for use of the stepped mouthpiece and the study procedures.\n* Subjects who have participated in a clinical trial in the previous month.'}, 'identificationModule': {'nctId': 'NCT01069068', 'briefTitle': 'Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry', 'organization': {'class': 'OTHER', 'fullName': "Doctor's Directive Strategies Inc."}, 'officialTitle': 'Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry', 'orgStudyIdInfo': {'id': 'RDD-2009-001'}}, 'contactsLocationsModule': {'locations': [{'zip': 'L5L3P9', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr John Viviano and Associates', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'John S Viviano, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr John Viviano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Doctor's Directive Strategies Inc.", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr John Viviano', 'investigatorAffiliation': "Doctor's Directive Strategies Inc."}}}}