Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients
This study has been completed.
Sponsor:
Facial Concepts, Inc.
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
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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:
|
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
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:
No publications provided
| 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:
|
Apnea Sleep Apnea Syndromes Snoring Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Respiratory Sounds |
ClinicalTrials.gov processed this record on May 23, 2013