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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Primary Snoring Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Facial-Flex

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.

Group Type OTHER

Facial-Flex

Intervention Type DEVICE

Oral exercise device

Interventions

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Facial-Flex

Oral exercise device

Intervention Type DEVICE

Other Intervention Names

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Facial Exerciser Facial Dynamic Resistance Neck Exerciser

Eligibility 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard B Berry, M.D.

Role: PRINCIPAL_INVESTIGATOR

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