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

Primary Purpose

Primary Snoring, Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facial-Flex
Sponsored by
Facial Concepts, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Snoring focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shands Sleep Disorders Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Facial-Flex

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Apnea-Hypopnea Index (AHI)
The number of apneas and hypopneas per hour of monitoring

Full Information

First Posted
February 28, 2012
Last Updated
April 29, 2013
Sponsor
Facial Concepts, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01554904
Brief Title
Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients
Official Title
Facial-Flex as a Treatment for Snoring
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Facial Concepts, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Snoring, Sleep Apnea
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facial-Flex
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Facial-Flex
Other Intervention Name(s)
Facial Exerciser, Facial Dynamic Resistance, Neck Exerciser
Intervention Description
Oral exercise device
Primary Outcome Measure Information:
Title
Snore Index
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
Secondary Outcome Measure Information:
Title
Apnea-Hypopnea Index (AHI)
Description
The number of apneas and hypopneas per hour of monitoring
Time Frame
baseline and after 6 weeks of facial muscle training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Berry, M.D.
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands Sleep Disorders Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Gary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158
Results Reference
result
PubMed Identifier
12572260
Citation
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.
Results Reference
result
Citation
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
Results Reference
result

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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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