Primary SnoringNCT01554904
Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients
A study testing Facial-Flex in people with Primary Snoring and Sleep Apnea, run by Facial Concepts, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Snoring, Sleep Apnea
- What is being tested?
- Facial-Flex
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Sleep Disorders Center
Gainesville, Florida, 32606
About this study
Official title: Facial-Flex as a Treatment for Snoring
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.
Read the 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.
- Conditions
- Primary Snoring, Sleep Apnea
- Being tested
- Facial-Flex
- 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
- Medical subject headings
- Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial-FlexDevice
Also called Facial Exerciser, Facial Dynamic Resistance, Neck Exerciser
Oral exercise device
| Study group | Role | What they receive |
|---|---|---|
| Facial-Flex | Other | 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. Receives: Device: Facial-Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline and after 6 weeks of facial muscle training
Secondary outcomes (1)
Apnea-Hypopnea Index (AHI)
The number of apneas and hypopneas per hour of monitoring
Measured: baseline and after 6 weeks of facial muscle training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Facial Concepts, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard B Berry, M.D., Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554904
- Sponsor's protocol ID
- Protocol 0102011
- Status last verified
- Apr 2013
- First submitted
- 28 Feb 2012
- Last updated
- 1 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158
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.
PubMed 12572260Barry 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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial-Flex as a Treatment for Snoring
- ClinicalTrials.gov ID
- NCT01554904
- Acronym / sponsor ID
- Protocol 0102011
- Conditions
- Primary Snoring, Sleep Apnea
- Keywords
- Sleep Study, Snoring, Sleep Apnea, Muscle Laxity, Oral Appliance, Facial Muscles, Neck Muscles, Upper Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Facial Concepts, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 1 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial-Flex | Other | Device: Facial-FlexThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial-FlexAlso: Facial Exerciser, Facial Dynamic Resistance, Neck ExerciserOral exercise device | Device | Facial-Flex |
Primary outcome
Snore Index
Time frame: baseline and after 6 weeks of facial muscle training
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).
1 secondary outcome
Apnea-Hypopnea Index (AHI)
Time frame: baseline and after 6 weeks of facial muscle training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationGary L. Grove, PhD - Skin Study Center, Broomall, PA The Journal of Geriatric Dermatology 1994;2(5):152-158
- Results publication: PubMed 12572260van 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 publicationBarry 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B Berry, M.D. principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial-Flex in people with Primary Snoring and Sleep Apnea, run by Facial Concepts, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snore Index (time frame: baseline and after 6 weeks of facial muscle training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01554904, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2013.