Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 2:21 AM
Study NCT ID:
NCT01554904
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2012-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D012913', 'term': 'Snoring'}], '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': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Richard.Berry@medicine.ufl.edu', 'phone': '3522621575', 'title': 'Richard B Berry, M.D. Principal Investigator', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was not a sham controlled trial. The number of participants was somewhat limited.'}}, 'adverseEventsModule': {'timeFrame': 'Six weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Facial-Flex', 'description': 'Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Snore Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Facial-Flex', 'description': 'Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.'}], 'classes': [{'title': 'Snore index Sleep study #1', 'categories': [{'measurements': [{'value': '348.4', 'spread': '82.3', 'groupId': 'OG000'}]}]}, {'title': 'Snore index Sleep study #2 (after training)', 'categories': [{'measurements': [{'value': '186.2', 'spread': '52.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '162.24', 'ciLowerLimit': '27.32', 'ciUpperLimit': '297.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '62.4', 'groupDescription': 'The null hypothesis is that the snore index would not be different after 6 weeks of treatment compared to baseline. The comparison group is the subjects completing the 6 weeks of training and the second sleep study.', 'statisticalMethod': 'paired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after 6 weeks of facial muscle training', 'description': 'The snore index is the number of snores per hour of monitoring. The pre-treatment and post-treatment (6 weeks) values will be compared. A snore is a vibratory noise usually noted during inspiration and associated with vibration of the uvula and palate. The snore sensor in this study is the nasal pressure cannula connected to a sensitive pressure transducer. Snoring is detected as a fine (high frequency) oscillation superimposed on the nasal pressure waveform. The device \\[Sleep Scout (ClevMed, Cleveland Ohio)\\] has an automated scoring detection algorithm to identify breaths with snoring. Each breath with vibration is counted as a snore. As the algorithm is automated and the same snore threshold was used for both baseline and 6 week sleep studies, this prevents technologist bias in detecting snores (breaths with vibration).', 'unitOfMeasure': 'snores per hour of monitoring', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects completing 6 weeks of training and Home Sleep Test # 2'}, {'type': 'SECONDARY', 'title': 'Apnea-Hypopnea Index (AHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Facial-Flex', 'description': 'Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.'}], 'classes': [{'title': 'Sleep study #1 (baseline)', 'categories': [{'measurements': [{'value': '3.31', 'spread': '2.77', 'groupId': 'OG000'}]}]}, {'title': 'Sleep study #2 (6 weeks)', 'categories': [{'measurements': [{'value': '4.16', 'spread': '4.01', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.85', 'ciLowerLimit': '-2.28', 'ciUpperLimit': '0.584', 'pValueComment': 'paired t test', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.66', 'groupDescription': 'Participants completing 6 weeks of training and the second sleep study. The null hypothesis was that the AHI would not be different after 6 weeks of training compared to baseline.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after 6 weeks of facial muscle training', 'description': 'The number of apneas and hypopneas per hour of monitoring', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing 6 weeks of training and second sleep study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Facial-Flex', 'description': 'Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Home Sleep Study 1', 'achievements': [{'comment': 'After informed consent signed.', 'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Start 6 Weeks of Facial Training', 'achievements': [{'comment': '1 participant was found to have obstructive sleep apnea on the home sleep study #1', 'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Complete 6 Weeks of Facial Training', 'achievements': [{'comment': '3 subjects withdrew during training', 'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Home Sleep Study 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Had sleep apnea on Home Study 1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects recruited at the Shands Sleep Disorders Center through posted advertisement.', 'preAssignmentDetails': 'The inclusion and exclusion criteria and study protocol were discussed with potential subjects. Subjects who desired to participate and met criteria signed an informed consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Facial-Flex', 'description': 'Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '15.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Number completing study'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-29', 'studyFirstSubmitDate': '2012-02-28', 'resultsFirstSubmitDate': '2013-02-24', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-29', 'studyFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Snore Index', 'timeFrame': 'baseline and after 6 weeks of facial muscle training', 'description': 'The snore index is the number of snores per hour of monitoring. The pre-treatment and post-treatment (6 weeks) values will be compared. A snore is a vibratory noise usually noted during inspiration and associated with vibration of the uvula and palate. The snore sensor in this study is the nasal pressure cannula connected to a sensitive pressure transducer. Snoring is detected as a fine (high frequency) oscillation superimposed on the nasal pressure waveform. The device \\[Sleep Scout (ClevMed, Cleveland Ohio)\\] has an automated scoring detection algorithm to identify breaths with snoring. Each breath with vibration is counted as a snore. As the algorithm is automated and the same snore threshold was used for both baseline and 6 week sleep studies, this prevents technologist bias in detecting snores (breaths with vibration).'}], 'secondaryOutcomes': [{'measure': 'Apnea-Hypopnea Index (AHI)', 'timeFrame': 'baseline and after 6 weeks of facial muscle training', 'description': 'The number of apneas and hypopneas per hour of monitoring'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep Study', 'Snoring', 'Sleep Apnea', 'Muscle Laxity', 'Oral Appliance', 'Facial Muscles', 'Neck Muscles', 'Upper Airway', 'Muscle Strength', 'Dynamic Resistance', 'Oral Exercise', 'Facial Toning', 'Facial Muscle Strength', 'Strap Muscles of the Neck', 'Apnea-Hypopnea'], 'conditions': ['Primary Snoring', 'Sleep Apnea']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Gary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158'}, {'pmid': '12572260', 'type': 'RESULT', 'citation': 'van Lieshout PH, Bose A, Namasivayam AK. Physiological effects of an 8-week mechanically aided resistance facial exercise program. Int J Orofacial Myology. 2002 Nov;28:49-73.'}, {'type': 'RESULT', 'citation': 'Barry M. Zide, M.D.; James P. Bradley, M.D.;Michael T. Longaker, M.D. Institute of Reconstructive Plastic Surgery at New York University Medical Ctr. Plastic Reconstructive Surgery 2000 March;1154-1158'}]}, 'descriptionModule': {'briefSummary': 'The study will test the hypothesis that training with the Facial-Flex exercise device for six weeks will improve snoring in patients with primary snoring or very mild sleep apnea.', 'detailedDescription': 'Subjects will be studied before and after 6 weeks of Facial-Flex training using portable monitoring. There will be 8 patient visits and 2 additional trips to the sleep center to return the portable sleep monitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a history of loud snoring but no observed breathing pauses by bed partner (or only very mild obstructive sleep apnea on a previous sleep study within the prior year) will be enrolled.\n* Very mild sleep apnea is defined here as an apnea-hypopnea index (AHI) \\< 10/hour).\n* This assumes that the AHI is computed using hypopnea defined as a 30% drop in the flow signal associated with a 4% or greater arterial oxygen desaturation.\n\nExclusion Criteria:\n\n* Prior upper airway surgery\n* Daytime sleepiness (Epworth sleepiness scale \\>12/24), (obesity BMI \\> 35 kg/M2)\n* Significant arterial oxygen desaturation defined as 5 minutes or more with an arterial oxygen desaturation less than 88%\n* Severe insomnia with less than 4 hours of sleep per night\n* Uncontrolled psychiatric disorder\n* Any disorder causing facial weakness\n* Pregnancy\n* Temporal mandibular joint problems.'}, 'identificationModule': {'nctId': 'NCT01554904', 'briefTitle': 'Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Facial Concepts, Inc.'}, 'officialTitle': 'Facial-Flex as a Treatment for Snoring', 'orgStudyIdInfo': {'id': 'Protocol 0102011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Facial-Flex', 'description': 'The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.', 'interventionNames': ['Device: Facial-Flex']}], 'interventions': [{'name': 'Facial-Flex', 'type': 'DEVICE', 'otherNames': ['Facial Exerciser', 'Facial Dynamic Resistance', 'Neck Exerciser'], 'description': 'Oral exercise device', 'armGroupLabels': ['Facial-Flex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32606', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands Sleep Disorders Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Richard B Berry, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine Pulmonary, Critical Care, and Sleep Medicine University of Florida College of Medicine Chief, Pulmonary Section, Malcom Randall VAMC Medical Director, Sleep Disorders Center Shands at AGH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Facial Concepts, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}