Table 3.
OSA Severity and Sleep On and Off the Study Drugs
| Variable | Placebo | Ato-oxy | Median Change | P Value |
|---|---|---|---|---|
| AHI, events/h | 31.2 [11.9 to 55.7] | 7.6 [2.4 to 20.3] | –28 [–40.0 to –10.5] | < .001 |
| %change | –65 [–88 to –52] | |||
| AHI NREM,a events/h | 32.5 [8.5 to 55.7] | 7.6 [2.4 to 20.3] | –22.0 [–40.0 to –7.6] | < .001 |
| %change | –65 [–88 to –40] | |||
| AHI REM,a,b events/h | 37.8 [25.4 to 56.3] | 2.2 [0 to 6.6] | –31.3 [–54.1 to –18.5] | .007 |
| %change | –92 [–95 to –83] | |||
| AI, events/h | 5.3 [1.3 to 15] | 0.3 [0 to 2.1] | –1.3 [–13.3 to –0.8] | < .001 |
| Fhypopneas, %AHI | 67.1 [44.3 to 86.8] | 93.3 [69.0 to 100] | 19.7 [–2.1 to 42.8] | .074 |
| ODI 3%, events/h | 17.1 [6.3 to 37.4] | 3.7 [0.6 to 20.2] | –6.2 [–16.7 to –2.6] | < .001 |
| Nadir Sao2, % | 82 [78.5 to 90.5] | 94 [88.5 to 95.5] | 9 [4 to 16] | < .001 |
| Arousal index, events/h | 46.4 [22.2 to 61.6] | 43.4 [33.5 to 52.8] | –6.1 [–15.7 to 8.3] | .35 |
| Total sleep time, min | 232 [162 to 326] | 303 [237 to 321] | 45 [–18 to 89.5] | .11 |
| Sleep efficiency, %TIB | 58 [41 to 83] | 75 [63.5 to 86] | 9 [–2 to 23.5] | .043 |
| EMGGG, %baseline | 2.2 [1.1 to 4.7] | 6.3 [3.0 to 18.3] | 2.7 [1.0 to 9.2] | < .001 |
Data are presented as median [interquartile range]. Baseline was calculated as the median Peak EMGGG during non-REM sleep with non-flow-limited breaths and relatively small esophageal pressure swings (–11.0 [–17.6 to –6.8] cm H2O). AHI = apnea-hypopnea index; AI = apnea index; Ato-oxy = combination of atomoxetine and oxybutynin; EMGGG = electromyographic activity from the genioglossus muscle; Fhypopneas = fraction of hypopneas over total events; NREM = non-rapid eye movement sleep; ODI 3% = oxygen desaturation index, 3% desaturation; ODI = oxygen desaturation index; REM = rapid eye movement; Sao2 = arterial oxygen saturation; TIB = time in bed.
AHI is calculated in supine position.
REM AHI was calculated only in eight patients in whom at least 10 min of REM sleep were available in both nights.