Primary Snoring, Sleep Apnea
Conditions
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
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.
Interventions
DEVICEFacial-Flex
Oral exercise device
Sponsors
Facial Concepts, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Snore Index | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | baseline and after 6 weeks of facial muscle training | The number of apneas and hypopneas per hour of monitoring |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Had sleep apnea on Home Study 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Facial-Flex |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age Continuous | 50.1 years STANDARD_DEVIATION 15.4 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
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).
Time frame: baseline and after 6 weeks of facial muscle training
Population: Subjects completing 6 weeks of training and Home Sleep Test # 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facial-Flex | Snore Index | Snore index Sleep study #1 | 348.4 snores per hour of monitoring | Standard Deviation 82.3 |
| Facial-Flex | Snore Index | Snore index Sleep study #2 (after training) | 186.2 snores per hour of monitoring | Standard Deviation 52.2 |
Comparison: 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.p-value: 0.0295% CI: [27.32, 297.16]paired t test
Secondary
Apnea-Hypopnea Index (AHI)
The number of apneas and hypopneas per hour of monitoring
Time frame: baseline and after 6 weeks of facial muscle training
Population: Participants completing 6 weeks of training and second sleep study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facial-Flex | Apnea-Hypopnea Index (AHI) | Sleep study #1 (baseline) | 3.31 events per hour | Standard Deviation 2.77 |
| Facial-Flex | Apnea-Hypopnea Index (AHI) | Sleep study #2 (6 weeks) | 4.16 events per hour | Standard Deviation 4.01 |
Comparison: 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.p-value: 0.2295% CI: [-2.28, 0.584]t-test, 2 sided