Table 2.
Polysomnographic Measures
| Sleep measure | Forehead sleep system (N = 54 baseline, N = 53 on device) | Vestibular sleep system (N = 52 baseline, N = 50 on device) |
Estimate of difference
(95% CI) |
p |
| Persistent sleep latency (mean ± SD) | ||||
| Baseline (min) | 69.7 ± 38.6 | 63.3 ± 32.4 | 6.5 (−7.3, 20.2) | |
| On Device (min) | 34.8 ± 26.3 | 40.4 ± 27.5 | −5.6 (−16.1, 4.9) | |
| Change from baseline (min) | −34.8 ± 34.0 | −23.0 ± 32.2 | −7.9 (−18.4, 2.6) | 0.092 |
| Relative change from baseline (%) | −48.1 ± 30.7 | −26.8 ± 50.9 | −19.8 (−37.7, −1.9) | 0.013 |
| Sleep efficiency (mean ± SD) | ||||
| Baseline (%) | 68.3 ± 10.6 | 70.4 ± 10.0 | −2.2 (−6.1, 1.8) | |
| On device (%) | 80.3 ± 9.5 | 80.7 ± 9.6 | −0.4 (−4.1, 3.4) | |
| Change from baseline (%) | 12.3 ± 9.8 | 10.4 ± 12.2 | 0.5 (−3.4, 4.5) | 0.759 |
| Relative change from baseline (%) | 19.9 ± 17.3 | 17.4 ± 24.7 | −0.6 (−7.1, 5.9) | 0.830 |
| Sleep latency (mean ± SD) | ||||
| Baseline (min) | 49.2 ± 29.8 | 41.7 ± 27.5 | 7.6 (−3.5, 18.6) | |
| On device (min) | 21.9 + 19.8 | 31.9 + 27.9 | −9.9 (−19.4, −0.5) | |
| Change from baseline (min) | −26.8 + 27.7 | −10.7 + 26.6 | −12.4 (−20.8, −4.1) | 0.004 |
| Relative change from baseline (%) | −50.2 + 46.0 | −7.6 + 91.0 | −39.0 (−66.4, −11.6) | 0.006 |
| Stage 1 latency (mean ± SD) | ||||
| Baseline (min) | 49.2 + 29.8 | 41.7 + 27.5 | 7.6 (−3.5, 18.6) | |
| On device (min) | 22.0 ± 19.7 | 31.9 + 27.9 | −9.9 (−19.3, −0.4) | |
| Change from baseline (min) | −26.7 + 27.4 | −10.7 + 26.6 | −12.4 (−20.7, −4.1) | 0.004 |
| Relative change from baseline (%) | −50.2 + 45.9 | −7.6 + 91.0 | −38.9 (−66.4, −11.5) | 0.006 |
| Stage 2 latency (mean ± SD) | ||||
| Baseline (min) | 57.3 ± 30.3 | 51.0 ± 32.5 | 6.3 (−5.8, 18.4) | |
| On device (min) | 27.6 ± 22.0 | 37.1 ± 28.1 | −9.5 (−19.3, 0.4) | |
| Change from baseline (min) | −29.3 ± 26.1 | −15.1 ± 29.8 | −11.5 (−19.9, −3.1) | 0.008 |
| Relative change from baseline (%) | −49.0 ± 31.3 | −13.4 ± 71.3 | −33.4 (−54.0, −12.7) | 0.002 |
| Stage 3 latency (mean ± SD) | ||||
| Baseline (min) | 117.9 ± 77.9 | 103.4 ± 51.1 | 14.5 (−12.4, 41.4) | |
| On device (min) | 67.4 ± 61.6 | 77.5 ± 64.9 | −10.1 (−36.0, 15.8) | |
| Change from baseline (min) | −50.9 ± 61.9 | −26.5 ± 63.8 | −17.4 (−39.4, 4.7) | 0.122 |
| Relative change from baseline (%) | −39.8 ± 28.2 | −20.7 ± 57.2 | −17.8 (−35.9, 0.4) | 0.055 |
| Total sleep time (mean ± SD) | ||||
| Baseline (min) | 327.7 ± 50.8 | 338.0 ± 47.9 | −10.4 (−29.4, 8.7) | |
| On device (min) | 385.4 ± 45.8 | 387.1 ± 46.2 | −1.7 (−19.7, 16.3) | |
| Change from baseline (min) | 58.8 ± 47.1 | 49.7 ± 58.8 | −11.7, 29.9 | 0.386 |
| Relative change from baseline (%) | 19.9 ± 17.3 | 17.4 ± 24.7 | −5.8, 10.8 | 0.555 |
| WASO (mean ± SD) | ||||
| Baseline (min) | 90.1 ± 40.1 | 85.8 ± 36.6 | 4.2 (−10.6, 19.0) | |
| On device (min) | 65.4 ± 36.8 | 56.9 ± 43.3 | 8.5 (−7.2, 24.2) | |
| Change from baseline (min) | −26.0 ± 40.0 | −29.4 ± 50.5 | −14.3, 21.2 | 0.703 |
| Relative change from baseline (%) | −18.3 ± 56.8 | −26.0 ± 67.5 | −16.7, 32.0 | 0.533 |
| Awakenings (mean ± SD) | ||||
| Baseline (#) | 9.9 ± 4.6 | 9.2 ± 3.8 | 0.7 (−1.0, 2.3) | |
| On device (#) | 8.7 ± 3.5 | 8.1 ± 3.7 | 0.7 (−0.7, 2.1) | |
| Change from baseline (#) | −1.3 ± 4.0 | −1.2 ± 2.9 | −1.4, 1.3 | 0.960 |
| Relative change from baseline (%) | −1.8 ± 46.5 | −10.5 ± 35.9 | −7.6, 25.0 | 0.292 |