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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Facial Concepts, Inc.
ClinicalTrials.gov Identifier:
NCT01554904
First received: February 28, 2012
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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 Intervention
Primary Snoring
Sleep Apnea
Device: Facial-Flex

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Facial-Flex as a Treatment for Snoring

Resource links provided by NLM:


Further study details as provided by Facial Concepts, Inc.:

Primary Outcome Measures:
  • Snore Index [ Time Frame: baseline and after 6 weeks of facial muscle training ] [ Designated as safety issue: No ]
    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:
  • Apnea-Hypopnea Index (AHI) [ Time Frame: baseline and after 6 weeks of facial muscle training ] [ Designated as safety issue: No ]
    The number of apneas and hypopneas per hour of monitoring


Enrollment: 18
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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-Flex
  • Facial Exerciser
  • Facial Dynamic Resistance
  • Neck Exerciser

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554904

Locations
United States, Florida
Shands Sleep Disorders Center
Gainesville, Florida, United States, 32606
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Gary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158

Responsible Party: Facial Concepts, Inc.
ClinicalTrials.gov Identifier: NCT01554904     History of Changes
Other Study ID Numbers: Protocol 0102011
Study First Received: February 28, 2012
Results First Received: February 24, 2013
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

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:
Sleep Apnea Syndromes
Snoring
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014