Table 2.
Median results for sleep parameters from overnight polysomnogram results by visit in the per protocol population
| Treatment (N=58) | Control (N=73) | Between group P-value | |||||
|---|---|---|---|---|---|---|---|
| Variable | Baseline | 6 Months | Change | Baseline | 6 Months | Change | |
| AHI (events/hour) |
49 35, 60 |
21 11, 35 |
−23 −38, −10 |
40 31, 54 |
42 32, 60 |
1 −7, 15 |
<.001 |
| CAI (events/hour) |
30 16, 43 |
1 0, 7 |
−20 −40, −13 |
21 14, 35 |
22 10, 35 |
−3 −11, 8 |
<.001 |
| ODI4% (events/hour) |
41 30, 56 |
19 8, 37 |
−19 −33, −3 |
33 25, 50 |
39 26, 57 |
3 −6, 14 |
<.001 |
| Minutes of Sleep with O2 | 33 | 14 | −16 | 25 | 28 | 1 | <.001 |
| Saturation<90% (minutes) | 16, 87 | 2, 44 | −44, 0 | 4, 58 | 8, 63 | −14, 16 | |
| Percent of Sleep with O2 | 9 | 5 | −4 | 9 | 8 | 0 | 0.003 |
| Saturation<90% (%) | 5, 27 | 1, 20 | −10, 1 | 2, 17 | 2, 19 | −5, 5 | |
| Average O2 Saturation | 92.6 | 93.3 | 0.7 | 93.0 | 92.7 | 0.1 | 0.006 |
| during sleep (%) | 91.3, 94.2 | 91.9, 94.7 | −0.4, 1.7 | 91.9, 94.4 | 91.8, 93.9 | −0.8, 0.8 | |
| Lowest O2 Saturation | 81.0 | 81.5 | 2.0 | 82.0 | 81.0 | −1.0 | 0.011 |
| during sleep (%) | 76.0, 84.0 | 77.0, 87.0 | −3.0, 5.0 | 77.0, 85.0 | 77.0, 84.0 | −4.0, 3.0 | |
Reported as median and interquartile range
P-value from Mann-Whitney test for difference in change from baseline between groups (2-sided)
AHI apnea-hypopnea index; CAI central apnea index; ODI4% oxygen desaturation ≥4% index; O2 oxygen