Clinical Study
A Randomized Crossover Trial of a Pressure Relief Technology (SensAwake™) in Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea
Table 1
Objective sleep quality in CPAP devices with and without SensAwake.
| | SensAwake ON (mean ± SE) | SensAwake OFF (mean ± SE) | Mean difference (95% CI) | value |
| CPAP data | Number of days device used | 12.1 ± 0.4 | 12.2 ± 0.3 | −0.15 (−0.97, 0.68) | 0.723 | Average minutes used, days on therapy | 314.7 ± 14.6 | 324.9 ± 12.8 | −10.2 (−28.9, 7.9) | 0.264 | Average minutes used, all days | 272.7 ± 17.1 | 289.1 ± 15.2 | −16.4 (−40.6, 7.8) | 0.180 | AHI (events/hour) | 5.2 ± 0.6 | 3.6 ± 0.5 | 1.6 (0.6, 2.7) | 0.004 | Length of apnea (Sec) | 13.9 ± 0.5 | 13.2 ± 0.5 | 0.7 (−0.3, 1.6) | 0.158 | System leak (L/min) | 41.7 ± 2.5 | 48.9 ± 3.0 | −7.2 (−10.5, −3.9) | <0.001 | 90th-percentile system leak (L/min) | 59.4 ± 3.3 | 64.3 ± 3.6 | −4.9 (−9.2, −0.7) | 0.025 | Time with excessive leak (%) | 18.8 ± 3.0 | 26.4 ± 4.1 | −7.5 (−12.8, −2.3) | 0.006 |
| Actigraph data | Total sleep time (min) | 382.7 ± 13.5 | 378.9 ± 14.7 | 3.8 (−18.5, 26.1) | 0.721 | Sleep latency (min) | 3.1 ± 0.7 | 2.4 ± 0.7 | 0.6 (−0.8, 2.1) | 0.370 | Sleep efficiency (%) | 89.3 ± 1.2 | 89.0 ± 1.5 | 0.3 (−1.7, 2.3) | 0.777 | Wake after sleep onset (min) | 42.6 ± 5.5 | 43.4 ± 6.2 | −0.8 (−8.3, 6.8) | 0.835 | Number of awakenings (no.) | 11.2 ± 1.0 | 11.6 ± 0.9 | −0.3 (−1.8, 1.2) | 0.655 |
| PSG data | Total sleep time (min) | 459.4 ± 3.9 | 451.2 ± 6.6 | 8.2 (−3.9, 20.3) | 0.175 | Wake after sleep onset (min) | 79.6 ± 11.1 | 83.5 ± 9.7 | −3.9 (−21.3, 13.4) | 0.642 | Duration of REM (min) | 83.5 ± 7.2 | 84.4 ± 7.4 | −0.9 (−14.8, 13.0) | 0.895 | Duration of NREM (min) | 299.6 ± 9.8 | 294.0 ± 9.4 | 5.7 (−10.3, 21.6) | 0.469 | Sleep efficiency (%) | 83.2 ± 2.4 | 83.5 ± 2.0 | −0.3 (−4.6, 4.1) | 0.889 | AHI (events/hour) | 4.6 ± 1.3 | 4.6 ± 0.9 | −0.02 (−2.2, 2.2) | 0.985 |
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CPAP: continuous positive airway pressure; AHI: Apnea Hypopnea Index; CI: confidence interval; PSG: polysomnography; REM: rapid eye movement; NREM: nonrapid eye movement.
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