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

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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Snoring
Sleep Apnea
Intervention Device: Facial-Flex
Enrollment 18

Recruitment Details Subjects recruited at the Shands Sleep Disorders Center through posted advertisement.
Pre-assignment Details The inclusion and exclusion criteria and study protocol were discussed with potential subjects. Subjects who desired to participate and met criteria signed an informed consent.
Arm/Group Title Facial-Flex
Hide Arm/Group Description Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. 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.
Period Title: Overall Study
Started 18
Home Sleep Study 1 18 [1]
Start 6 Weeks of Facial Training 17 [2]
Complete 6 Weeks of Facial Training 14 [3]
Home Sleep Study 2 14
Completed 14
Not Completed 4
Reason Not Completed
Withdrawal by Subject             3
Had sleep apnea on Home Study 1             1
[1]
After informed consent signed.
[2]
1 participant was found to have obstructive sleep apnea on the home sleep study #1
[3]
3 subjects withdrew during training
Arm/Group Title Facial-Flex
Hide Arm/Group Description Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. 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.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
Number completing study
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  92.9%
>=65 years
1
   7.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
50.1  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
10
  71.4%
Male
4
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Snore Index
Hide Description 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).
Time Frame baseline and after 6 weeks of facial muscle training
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects completing 6 weeks of training and Home Sleep Test # 2
Arm/Group Title Facial-Flex
Hide Arm/Group Description:
Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. 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.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: snores per hour of monitoring
Snore index Sleep study #1 348.4  (82.3)
Snore index Sleep study #2 (after training) 186.2  (52.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Facial-Flex
Comments The null hypothesis is that the snore index would not be different after 6 weeks of treatment compared to baseline. The comparison group is the subjects completing the 6 weeks of training and the second sleep study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 162.24
Confidence Interval (2-Sided) 95%
27.32 to 297.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 62.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Apnea-Hypopnea Index (AHI)
Hide Description The number of apneas and hypopneas per hour of monitoring
Time Frame baseline and after 6 weeks of facial muscle training
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants completing 6 weeks of training and second sleep study
Arm/Group Title Facial-Flex
Hide Arm/Group Description:
Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. 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.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: events per hour
Sleep study #1 (baseline) 3.31  (2.77)
Sleep study #2 (6 weeks) 4.16  (4.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Facial-Flex
Comments Participants completing 6 weeks of training and the second sleep study. The null hypothesis was that the AHI would not be different after 6 weeks of training compared to baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments paired t test
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.85
Confidence Interval (2-Sided) 95%
-2.28 to 0.584
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.66
Estimation Comments [Not Specified]
Time Frame Six weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Facial-Flex
Hide Arm/Group Description Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. 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.
All-Cause Mortality
Facial-Flex
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Facial-Flex
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Facial-Flex
Affected / at Risk (%)
Total   0/18 (0.00%) 
This was not a sham controlled trial. The number of participants was somewhat limited.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Richard B Berry, M.D. Principal Investigator
Organization: University of Florida
Phone: 3522621575
Publications of Results:
Gary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158
Barry M. Zide, M.D.; James P. Bradley, M.D.;Michael T. Longaker, M.D. Institute of Reconstructive Plastic Surgery at New York University Medical Ctr. Plastic Reconstructive Surgery 2000 March;1154-1158
Responsible Party: Facial Concepts, Inc.
ClinicalTrials.gov Identifier: NCT01554904     History of Changes
Other Study ID Numbers: Protocol 0102011
First Submitted: February 28, 2012
First Posted: March 15, 2012
Results First Submitted: February 24, 2013
Results First Posted: May 1, 2013
Last Update Posted: May 1, 2013