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 used12.1 ± 0.412.2 ± 0.3−0.15 (−0.97, 0.68)0.723
Average minutes used, days on therapy314.7 ± 14.6324.9 ± 12.8−10.2 (−28.9, 7.9)0.264
Average minutes used, all days272.7 ± 17.1289.1 ± 15.2−16.4 (−40.6, 7.8)0.180
AHI (events/hour)5.2 ± 0.63.6 ± 0.51.6 (0.6, 2.7)0.004
Length of apnea (Sec)13.9 ± 0.513.2 ± 0.50.7 (−0.3, 1.6)0.158
System leak (L/min)41.7 ± 2.548.9 ± 3.0−7.2 (−10.5, −3.9)<0.001
90th-percentile system leak (L/min)59.4 ± 3.364.3 ± 3.6−4.9 (−9.2, −0.7)0.025
Time with excessive leak (%)18.8 ± 3.026.4 ± 4.1−7.5 (−12.8, −2.3)0.006

Actigraph data
Total sleep time (min)382.7 ± 13.5378.9 ± 14.73.8 (−18.5, 26.1)0.721
Sleep latency (min)3.1 ± 0.72.4 ± 0.70.6 (−0.8, 2.1)0.370
Sleep efficiency (%)89.3 ± 1.289.0 ± 1.50.3 (−1.7, 2.3)0.777
Wake after sleep onset (min)42.6 ± 5.543.4 ± 6.2−0.8 (−8.3, 6.8)0.835
Number of awakenings (no.)11.2 ± 1.011.6 ± 0.9−0.3 (−1.8, 1.2)0.655

PSG data
Total sleep time (min)459.4 ± 3.9451.2 ± 6.68.2 (−3.9, 20.3)0.175
Wake after sleep onset (min)79.6 ± 11.183.5 ± 9.7−3.9 (−21.3, 13.4)0.642
Duration of REM (min)83.5 ± 7.284.4 ± 7.4−0.9 (−14.8, 13.0)0.895
Duration of NREM (min)299.6 ± 9.8294.0 ± 9.45.7 (−10.3, 21.6)0.469
Sleep efficiency (%)83.2 ± 2.483.5 ± 2.0−0.3 (−4.6, 4.1)0.889
AHI (events/hour)4.6 ± 1.34.6 ± 0.9−0.02 (−2.2, 2.2)0.985

CPAP: continuous positive airway pressure; AHI: Apnea Hypopnea Index; CI: confidence interval; PSG: polysomnography; REM: rapid eye movement; NREM: nonrapid eye movement.