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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial-Flex | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facial-Flex | Device | Oral exercise device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Snore Index | 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). | baseline and after 6 weeks of facial muscle training |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | The number of apneas and hypopneas per hour of monitoring | baseline and after 6 weeks of facial muscle training |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard B Berry, M.D. | 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands Sleep Disorders Center | Gainesville | Florida | 32606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Gary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158 | ||
| 12572260 | Result | 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. | |
| Result | 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 |
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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.
Subjects recruited at the Shands Sleep Disorders Center through posted advertisement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Facial-Flex | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number completing study
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| ID | Title | Description |
|---|---|---|
| BG000 | Facial-Flex | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Snore Index | 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). | Subjects completing 6 weeks of training and Home Sleep Test # 2 | Posted | Mean | Standard Deviation | snores per hour of monitoring | baseline and after 6 weeks of facial muscle training |
|
Six weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Facial-Flex | 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. |
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This was not a sham controlled trial. The number of participants was somewhat limited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard B Berry, M.D. Principal Investigator | University of Florida | 3522621575 | Richard.Berry@medicine.ufl.edu |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Facial-Flex |
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. |
|
|
|
| Secondary | Apnea-Hypopnea Index (AHI) | The number of apneas and hypopneas per hour of monitoring | Participants completing 6 weeks of training and second sleep study | Posted | Mean | Standard Deviation | events per hour | baseline and after 6 weeks of facial muscle training |
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| 0 |
| 17 |
| 0 |
| 18 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |