Table 2.
Changes in sleep metrics in the pooled heart failure population
| Baseline observed | 6–month active therapy | 12–month active therapy | |||
|---|---|---|---|---|---|
| Observed | Paired change from baseline | Observed | Paired change from baseline | ||
| Proportion of patients with ≥50% reduction in AHI (%) | 53 (41/77) (42%, 64%) | 57 (40/70) (45%, 68%) | |||
| CAI (events/h)* | 26.2 ± 17.7 (93) 22.1 [13.4–37.2] | 4.1 ± 6.0 (77) 1.4 [0.2–5.4] | –21.8 ± 18.1 (77) –20.0 [–35.0 to –8.3] P < 0.001 | 3.5 ± 6.5 (70) 0.9 [0.0–3.5] | –23.2 ± 16.9 (70) –19.9 [–34.6 to –11.8] P < 0.001 |
| AHI (events/h)* | 47.1 ± 18.5 (93) 45.8 [32.0–58.3] | 25.2 ± 18.9 (77) 20.9 [10.0–34.5] | –21.2 ± 18.2 (77) –20.7 [–37.8 to –7.5] P < 0.001 | 24.9 ± 18.6 (70) 19.5 [10.7–34.4] | –22.6 ± 18.1 (70) –22.0 [–35.6 to –5.9] P < 0.001 |
| Arousal index (events/h)* | 43.0 ± 18.7 (93) 40.6 [30.0–57.3] | 25.2 ± 14.2 (77) 21.0 [16.7–31.2] | –16.8 ± 19.1 (77) –14.3 [–27.7 to –3.6] P < 0.001 | 24.5 ± 13.8 (70) 19.4 [15.0–32.8] | –18.4 ± 20.9 (70) –16.2 [–35.1 to –4.7] P < 0.001 |
| Percent sleep in REM* | 10.4 ± 7.2 (93) 9.6 [5.1–15.8] | 13.8 ± 8.2 (77) 13.4 [8.5–17.7] | 2.9 ± 8.2 (77) 1.1 [–3.3 to 7.7] P = 0.003 | 14.6 ± 8.8 (70) 13.9 [7.2–20.9] | 3.6 ± 9.0 (70) 2.7 [–2.6 to 8.0] P = 0.001 |
| ODI4 (events/h)* | 43.2 ± 20.2 (93) 41.0 [29.5–54.6] | 24.2 ± 19.8 (77) 20.1 [8.2–33.4] | –18.3 ± 16.9 (77) –17.1 [–30.4 to –5.3] P < 0.001 | 24.2 ± 19.4 (70) 18.9 [8.8–32.4] | –19.9 ± 19.9 (70) –20.4 [–32.3 to –4.7] P < 0.001 |
| Percent of sleep with O2 saturation < 90%* | 15.7 ± 16.6 (92) 9.8 [3.4–23.9] | 10.7 ± 15.1 (77) 4.8 [1.1–16.0] | –3.9 ± 13.7 (76) –4.1 [–9.1 to 1.5] P = 0.014 | 9.4 ± 13.2 (70) 4.4 [0.9–14.4] | –6.6 ± 15.8 (69) –4.1 [–9.8 to 0.1]P < 0.001 |
Values are mean ± standard deviation (n), or median [interquartile range].
For number of patients at baseline, three control subjects exited prior to the 6‐month therapy activation visit (their baseline for on‐therapy assessments); thus, a total of 93 subjects with heart failure were available for the pooled analyses of active therapy.
AHI, apnoea–hypopnoea index; CAI, central apnoea index; ODI4, oxygen desaturation index of ≥4%; REM, rapid eye movement.
*
Nominal two‐sided P‐value from paired t‐test for change from baseline.