Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-01 @ 5:19 PM
Study NCT ID:
NCT03219034
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eschneiderman@tamu.edu', 'phone': '2148288377', 'title': 'Dr. Emet Schneiderman', 'organization': 'Texas A&M University College of Dentistry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Each participant participated for 9 weeks, for which time adverse event data were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Appliance A', 'description': 'Oral Appliance A - Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX. Worn for 4 weeks.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oral Appliance B', 'description': 'Oral Appliance B: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX. Worn for 4 weeks.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 1, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Oral appliance intolerance', 'notes': 'Intolerance to oral appliance therapy due to dental sensitivity. This occurred in a subject in Sequence B-A in response to oral appliance B during the first leg of the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Respiratory Event Index (REI) at T2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Appliance Sequence - A -- B', 'description': 'Group STARTING with this appliance: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.\n\nTrade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX.\n\n1 week washout followed by Appliance B for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.\n\nTrade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX'}, {'id': 'OG001', 'title': 'Oral Appliance Sequence B -- A', 'description': 'Group STARTING with Appliance B for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.\n\nTrade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX Used Appliance A for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Used for period of first 4 weeks.\n\nTrade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX'}], 'classes': [{'title': 'At T2 (end of 1st 4 wk leg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '26.7'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '31.2'}]}]}, {'title': 'At T4 (end of 2nd 4 wk leg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '15.5'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '10.4', 'upperLimit': '16.6'}]}]}], 'analyses': [{'pValue': '0.152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.8', 'groupDescription': 'Cross-over design: Median differences between oral appliances at the end of the first 4-week leg of the study (T2). The hypothesis tested was that REI would be lowered more with Appliance A than B.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'Number of apneas and hypopneas (respiratory events) per hour of recording; REI was reported instead of AHI, as it is a more appropriate measure for home sleep testing.', 'unitOfMeasure': 'number of events per hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '20 subjects dropped out or were lost to follow-up by T2. An additional 6 dropped out before T4, bringing the total number of dropouts to 26.'}, {'type': 'SECONDARY', 'title': 'Stable Sleep Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Appliance Sequence - A -- B', 'description': 'Group STARTING with this appliance: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.\n\nTrade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX'}, {'id': 'OG001', 'title': 'Oral Appliance Sequence B-A', 'description': 'Group STARTING with this appliance: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.\n\nTrade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX'}], 'classes': [{'title': 'At T2 (end of 1st 4 wk leg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.35', 'spread': '17.70', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '18.3', 'groupId': 'OG001'}]}]}, {'title': 'At T4 (end of 2nd 4 wk leg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.82', 'spread': '21.12', 'groupId': 'OG000'}, {'value': '52.38', 'spread': '19.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis', 'unitOfMeasure': 'percentage of high frequency coupling', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 subject dropped out or were lost to follow-up at T2. An additional 6 dropped out before T4.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Appliance Sequence A-B', 'description': 'Group STARTING with Appliance A for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Used for period of first 4 weeks.\n\nTrade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX\n\nUsed Appliance B for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.\n\nTrade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX'}, {'id': 'FG001', 'title': 'Oral Appliance Sequence B-A', 'description': 'Group STARTING with Appliance B for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.\n\nTrade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX\n\nUsed Appliance A for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Used for period of first 4 weeks.\n\nTrade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Additional dental work needed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'UPPP Surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Dental sensitivity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death in family', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '162 individuals screened for eligibility; 62 enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Appliance Sequence - A -- B', 'description': 'Group STARTING with Appliance A for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX. One week washout with no oral appliance usage.\n\nUsed Appliance B for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX.'}, {'id': 'BG001', 'title': 'Oral Appliance Sequence B -- A', 'description': 'Group STARTING with Appliance B for first leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX. One week washout with no oral appliance usage.\n\nUsed Appliance A for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'groupId': 'BG000', 'lowerLimit': '46.3', 'upperLimit': '69.0'}, {'value': '61.0', 'groupId': 'BG001', 'lowerLimit': '52.0', 'upperLimit': '66.0'}, {'value': '61.0', 'groupId': 'BG002', 'lowerLimit': '51.0', 'upperLimit': '68.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'BG000', 'lowerLimit': '27.4', 'upperLimit': '34.0'}, {'value': '31.0', 'groupId': 'BG001', 'lowerLimit': '28.0', 'upperLimit': '33.6'}, {'value': '31.0', 'groupId': 'BG002', 'lowerLimit': '29.9', 'upperLimit': '33.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Respiratory Event Index (events/hr)', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'groupId': 'BG000', 'lowerLimit': '17.9', 'upperLimit': '41.8'}, {'value': '36.1', 'groupId': 'BG001', 'lowerLimit': '22.3', 'upperLimit': '57.9'}, {'value': '33.7', 'groupId': 'BG002', 'lowerLimit': '20.7', 'upperLimit': '54.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'Number of respiratory events per hour (number of apnea-hypopnea events divided by the number of recorded hours)', 'unitOfMeasure': 'number of events /hour', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Mean SaO2', 'classes': [{'categories': [{'measurements': [{'value': '93.0', 'groupId': 'BG000', 'lowerLimit': '92.0', 'upperLimit': '94.6'}, {'value': '93.1', 'groupId': 'BG001', 'lowerLimit': '91.0', 'upperLimit': '95.4'}, {'value': '93.0', 'groupId': 'BG002', 'lowerLimit': '91.0', 'upperLimit': '95.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Mean percentage of oxygen saturation values were obtained from each subject using pulse oximetry. Collectively these were not normally distributed so were summarized with the median and interquartile range.', 'unitOfMeasure': 'Percent', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Minimum SaO2', 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'BG000', 'lowerLimit': '76.0', 'upperLimit': '85.0'}, {'value': '82.0', 'groupId': 'BG001', 'lowerLimit': '77.0', 'upperLimit': '87.0'}, {'value': '80.0', 'groupId': 'BG002', 'lowerLimit': '77.0', 'upperLimit': '85.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Minimum oxygen percentage saturation values were obtained for each subject using pulse oximetry. Collectively these were not normally distributed so were summarized with the median and interquartile range.', 'unitOfMeasure': 'Percent', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': '31 subjects assigned to each oral appliance (OA) sequence group in cross-over design. 6 left study prior to receipt of OA, so demographics reflect those 56 subjects who received the intervention. See figure 1 in publication for details.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-14', 'size': 384440, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-20T11:44', 'hasProtocol': True}, {'date': '2018-07-26', 'size': 3612261, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-05-20T11:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2017-07-11', 'resultsFirstSubmitDate': '2020-11-20', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-06', 'studyFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Event Index (REI) at T2', 'timeFrame': '4 weeks', 'description': 'Number of apneas and hypopneas (respiratory events) per hour of recording; REI was reported instead of AHI, as it is a more appropriate measure for home sleep testing.'}], 'secondaryOutcomes': [{'measure': 'Stable Sleep Percent', 'timeFrame': '4 weeks', 'description': 'Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['oral appliance', 'sleep quality', 'sleep apnea'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '32942939', 'type': 'RESULT', 'citation': 'Schneiderman E, Schramm P, Hui J, Wilson PD, Moura P, German Z, McCann A, Newton M. Randomized Trial of 2 Self-Titrated Oral Appliances for Airway Management. J Dent Res. 2021 Feb;100(2):155-162. doi: 10.1177/0022034520956977. Epub 2020 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the effectiveness of the two leading oral appliances (OAs) designs for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness of OAs has come under question since different designs are combined in evaluating treatment efficacy, for example when comparing them to continuous positive airway pressure Due to the wide range of reported efficacy (53 to 90%), it is of great value to identify the most effective design to guide sleep practitioners and patients.', 'detailedDescription': "The two prominent oral appliances used in treating obstructive sleep apnea differ in their designs, mid-line traction versus bilateral thrust. From a clinical perspective, it is important to know which design is superior and should be the 'treatment of choice' for improving airway function and sleep quality. These two designs differ in their protrusive mechanisms that are categorized in general under four main types: bilateral compression, bilateral thrust, midline compression and mid-line traction. Although the two designs considered in this proposal have undergone the most rigorous testing individually, well controlled 'head-to-head' trials as proposed here have not been conducted to determine their efficacy within a single test population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* OSA PSG or PG diagnosed adults within 1 year\n* age \\>18\n* Currently treated with continuous positive airway pressure (CPAP)\n* AHI ≥ \\>30 events/hour of sleep\n* Two or more OSA symptoms (snoring, witnessed apnea or daytime hypersomnolence complaint)\n* BMI ≥ 30\n* At least 8 teeth per arch to support either OA device\n* Central and mixed apnea index \\<5 events/hour\n* Mallampati score from I to III\n* Palatine tonsils - grade 0, 1, or 2\n* Consent to study's timeline\n* Willingness to wear home sleep test apparatus for at least 4 nights\n* Willingness to wear an oral appliance every night for 8 weeks\n* Willingness to pick up and return home sleep test kits as needed\n\nExclusion Criteria:\n\n* Cardiac \\& pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD);\n* Central sleep apnea;\n* Comorbidities with other sleep disorders\n* No active TMD or jaw muscle pain\n* Morphological airway abnormalities\n* Pre-existing difficulty swallowing; throat or neck related health issues\n* Endocrine dysfunction\n* Severe psychiatric disorders;\n* Previous OA therapy; ENT surgery\n* Restrictions in jaw opening\n* Pregnancy / breast feeding or intent to become pregnant during the study\n* Inability to apply the sleep recorders"}, 'identificationModule': {'nctId': 'NCT03219034', 'briefTitle': 'Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality', 'organization': {'class': 'OTHER', 'fullName': 'Texas A&M University'}, 'officialTitle': 'Mid-line Traction Versus Bilateral Thrust Oral Appliances: A Trial to Determine Superiority for Improving Upper Airway Function and Sleep Quality', 'orgStudyIdInfo': {'id': '2017-0390'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral appliance - A', 'description': 'Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.\n\nTrade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX', 'interventionNames': ['Device: oral appliance - A ; washout; oral appliance B', 'Device: oral appliance - B; washout; oral appliance A']}, {'type': 'EXPERIMENTAL', 'label': 'Oral appliance - B', 'description': 'Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.\n\nTrade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX', 'interventionNames': ['Device: oral appliance - A ; washout; oral appliance B', 'Device: oral appliance - B; washout; oral appliance A']}], 'interventions': [{'name': 'oral appliance - A ; washout; oral appliance B', 'type': 'DEVICE', 'otherNames': ['"TAP1" Oral Appliance; washout; "SomnoDent Flex"'], 'description': 'Anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. 1 week washout followed by anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.', 'armGroupLabels': ['Oral appliance - A', 'Oral appliance - B']}, {'name': 'oral appliance - B; washout; oral appliance A', 'type': 'DEVICE', 'otherNames': ['"SomnoDent Flex"; washout; "TAP1"'], 'description': 'Anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. 1-week washout followed by anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.', 'armGroupLabels': ['Oral appliance - A', 'Oral appliance - B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas A&M University College of Dentistry', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Emet Schneiderman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas A&M University College of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas A&M University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr.', 'investigatorFullName': 'Emet D. Schneiderman, PhD', 'investigatorAffiliation': 'Texas A&M University'}}}}