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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea; Primary Snoring
• Intervention / Treatment: Device: Facial-Flex

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32606
      • Shands Sleep Disorders Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Snore Index	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).	baseline and after 6 weeks of facial muscle training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index (AHI)	The number of apneas and hypopneas per hour of monitoring	baseline and after 6 weeks of facial muscle training

Collaborators and Investigators

• Sponsor: Facial Concepts, Inc.
• Investigators: 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

Publications and helpful links

General Publications

• Gary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158
• van Lieshout PH, Bose A, Namasivayam AK. Physiological effects of an 8-week mechanically aided resistance facial exercise program. Int J Orofacial Myology. 2002 Nov;28:49-73.
• Zide BM, Bradley JP, Longaker MT. Lip service for the stiff upper lip. Plast Reconstr Surg. 2000 Mar;105(3):1154-8; discussion 1159-61. doi: 10.1097/00006534-200003000-00051.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 28, 2012
• First Submitted That Met QC Criteria: March 13, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Sleep Apnea; Oral Appliance; Muscle Strength; Sleep Study; Snoring; Muscle Laxity; Facial Muscles; Neck Muscles; Upper Airway; Dynamic Resistance; Oral Exercise; Facial Toning; Facial Muscle Strength; Strap Muscles of the Neck; Apnea-Hypopnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Respiratory Sounds; Sleep Apnea Syndromes; Snoring
• Other Study ID Numbers: Protocol 0102011