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

Completed · Not applicable

Conditions studied: Primary Snoring, Sleep Apnea

In brief

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.

Key facts

Study ID

NCT01554904

Run by

Facial Concepts, Inc.

People needed

18

Starts

2012-02-01

Expected to finish

2012-12-01

Last updated by the study team

2013-05-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shands Sleep Disorders Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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