Facial-Flex as a Treatment for Snoring
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| City: |
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Gainesville |
| State: |
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Florida |
| Zip Code: |
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32606 |
| Conditions: |
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Primary Snoring - Sleep Apnea |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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Inclusion Criteria:
- 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.
- Very mild sleep apnea is defined here as an apnea-hypopnea index (AHI) < 10/hour).
- 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.
Exclusion Criteria:
- Prior upper airway surgery
- Daytime sleepiness (Epworth sleepiness scale >12/24), (obesity BMI > 35 kg/M2)
- Significant arterial oxygen desaturation defined as 5 minutes or more with an
arterial oxygen desaturation less than 88%
- Severe insomnia with less than 4 hours of sleep per night
- Uncontrolled psychiatric disorder
- Any disorder causing facial weakness
- Pregnancy
- Temporal mandibular joint problems.
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| NCT ID: |
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NCT01554904 |
| Primary Contact: |
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Principal Investigator
Richard B Berry, M.D.
Professor of Medicine Pulmonary, Critical Care, and Sleep Medicine University of Florida College of
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| Backup Contact: |
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N/A |
| Location Contact: |
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Gainesville, Florida 32606
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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