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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01554904
Recruitment Status : Completed
First Posted : March 15, 2012
Results First Posted : May 1, 2013
Last Update Posted : May 1, 2013
Sponsor:
Information provided by (Responsible Party):
Facial Concepts, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Snoring Sleep Apnea Device: Facial-Flex Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Facial-Flex as a Treatment for Snoring
Study Start Date : February 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring

Arms and Interventions
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Arm Intervention/treatment
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.
 Device: Facial-Flex
Oral exercise device
Other Names:
  • Facial Exerciser
  • Facial Dynamic Resistance
  • Neck Exerciser


Outcome Measures
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Primary Outcome Measures :
  1. Snore Index [ Time Frame: baseline and after 6 weeks of facial muscle training ]
    The snore index is the number of snores per hour of monitoring. The pre-treatment and post-treatment (6 weeks) values will be compared. A snore is a vibratory noise usually noted during inspiration and associated with vibration of the uvula and palate. The snore sensor in this study is the nasal pressure cannula connected to a sensitive pressure transducer. Snoring is detected as a fine (high frequency) oscillation superimposed on the nasal pressure waveform. The device [Sleep Scout (ClevMed, Cleveland Ohio)] has an automated scoring detection algorithm to identify breaths with snoring. Each breath with vibration is counted as a snore. As the algorithm is automated and the same snore threshold was used for both baseline and 6 week sleep studies, this prevents technologist bias in detecting snores (breaths with vibration).


Secondary Outcome Measures :
  1. Apnea-Hypopnea Index (AHI) [ Time Frame: baseline and after 6 weeks of facial muscle training ]
    The number of apneas and hypopneas per hour of monitoring


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554904


Locations
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United States, Florida
Shands Sleep Disorders Center
Gainesville, Florida, United States, 32606
Sponsors and Collaborators
Facial Concepts, Inc.
Investigators
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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 Medicine Chief, Pulmonary Section, Malcom Randall VAMC Medical Director, Sleep Disorders Center Shands at AGH
More Information
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Publications of Results:
Gary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158

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Responsible Party: Facial Concepts, Inc.
ClinicalTrials.gov Identifier: NCT01554904    
Other Study ID Numbers: Protocol 0102011
First Posted: March 15, 2012    Key Record Dates
Results First Posted: May 1, 2013
Last Update Posted: May 1, 2013
Last Verified: April 2013
Keywords provided by Facial Concepts, Inc.:
Sleep Study
Snoring
Sleep Apnea
Muscle Laxity
Oral Appliance
Facial Muscles
Neck Muscles
Upper Airway
 Muscle Strength
Dynamic Resistance
Oral Exercise
Facial Toning
Facial Muscle Strength
Strap Muscles of the Neck
Apnea-Hypopnea
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Snoring
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds