Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients



Status:Completed
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:February 2012
End Date:February 2013
Contact:Richard B Berry, M.D.
Email:berryrb@medicine.ufl.edu

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Facial-Flex as a Treatment for Snoring


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.

Inclusion Criteria:

- Patients with a history of loud snoring but no observed breathing pauses by
bedpartner (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

- TMJ problems.
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Gainesville, Florida 32606
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