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

Facial Concepts

Status: Completed

Conditions: Primary Snoring; Sleep Apnea

Treatments: Device: Facial-Flex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01554904

Protocol 0102011

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Facial-Flex

Other group

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.

Treatment:

Device: Facial-Flex