FDA Study - Full Breath Solution
These are the data from a clinical study of 18 patients who were treated for Sleep Apnea with the Mandibular Full Breath Solution Sleep Appliance. These figures were presented to the FDA for certification in June 2009.
| Number | Name | Gender | Age | BMI | Pre-TX AHI | Post-TX AHI | Pre-TX O2 Nadir | Post-TX O2 Nadir | Vertical Opening | Mandibular Advance
|
| 1 | Sieg | Male | 58 | 22.5 | 28 | 1.5 | 85 | 93 | 1-2MM's | 1-2MM's
|
| 2 | Doss | Male | 59 | 26.8 | 107.1 | 32.1 | 87 | 90 | 1-2MM's | 1-2MM's
|
| 3 | Week | Male | 69 | 25.8 | 17 | 5.2 | 82 | 82 | 1-2MM'S | 1-2MM'S
|
| 4 | Linc | Male | 54 | 30.5 | 8 | 3.8 | 90 | 86 | 1-2MM'S | 1-2MM'S
|
| 5 | Myle | Female | 72 | 24.2 | 13 | 3.5 | 91 | 90 | 1-2MM'S | 1-2MM'S
|
| 6 | Brow | Female | 38 | 29 | 9.5 | 4 | 85 | 85 | 1-2MM'S | 1-2MM'S
|
| 7 | Brow | Male | 58 | 27 | 17 | 1.8 | 91 | 93 | 1-2MM'S | 1-2MM'S
|
| 8 | Ligo | Female | 44 | 35.6 | 7 | 0.7 | 89 | 94 | 1-2MM'S | 1-2MM'S
|
| 9 | Lars | Female | 65 | 26.8 | 56.2 | 13.2 | 81 | 90 | 1-2MM'S | 1-2MM'S
|
| 10 | Piek | Male | 70 | 27 | 21 | 7 | 84 | 94 | 1-2MM'S | 1-2MM'S
|
| 11 | Embr | Female | 64 | 24.8 | 6.7 | 2.2 | 83 | 91 | 1-2MM'S | 1-2MM'S
|
| 12 | John | Male | 31 | 33.4 | 33 | 2 | 87 | 92 | 1-2MM'S | 1-2MM'S
|
| 13 | Kris | Male | 58 | 30.1 | 67 | 8.5 | 88 | 94 | 1-2MM'S | 1-2MM'S
|
| 14 | Bagb | Male | 59 | 28 | 48 | 7 | 80 | 91 | 1-2MM'S | 1-2MM'S
|
| 15 | Hart | Male | 67 | 25 | 17.1 | 0.3 | 83 | 91 | 1-2MM'S | 1-2MM'S
|
| 16 | Chav | Male | 54 | 22.7 | 24.6 | 6.1 | 76.7 | 95 | 1-2MM'S | 1-2MM'S
|
| 17 | Kave | Male | 76 | 34 | 87 | 18 | 78 | 86 | 1-2MM'S | 1-2MM'S
|
| 18 | Roth | Male | 71 | 22 | 47.5 | 13.4 | 79 | 86 | 1-2MM'S | 1-2MM'S
|
| Total: | | 1067 | 495.2 | 614.7 | 130.3 | 1519.7 | 1623 | |
|
| Average: | | 59.3 | 27.5 | 34 | 7.2 | 84.4 | 90.2 | |
|
On average, there was a 78.9% drop in AHI and a 6.87% increase in O2 Nadir.