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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited at the Shands Sleep Disorders Center through posted advertisement.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Facial-Flex 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.

Participant Flow:   Overall Study
    Facial-Flex
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 
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



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number completing study

Reporting Groups
  Description
Facial-Flex 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.

Baseline Measures
   Facial-Flex 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   13 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.1  (15.4) 
Gender 
[Units: Participants]
 
Female   10 
Male   4 
Region of Enrollment 
[Units: Participants]
 
United States   14 


  Outcome Measures

1.  Primary:   Snore Index   [ Time Frame: baseline and after 6 weeks of facial muscle training ]

2.  Secondary:   Apnea-Hypopnea Index (AHI)   [ Time Frame: baseline and after 6 weeks of facial muscle training ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was not a sham controlled trial. The number of participants was somewhat limited.


  More Information

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
e-mail: Richard.Berry@medicine.ufl.edu


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