Table 1. Primary and secondary endpoints of the trial*.
| Parameter | Group | n | Visit 0 | Visit 2 | Ø difference | 95% CI | p-value | ||
|---|---|---|---|---|---|---|---|---|---|
| AHI | Control | 16 | 35.7 ± 19.4 | 28.6 ± 19.3 | −7.2 | −25.7 | −11.0 | } | 0.036 |
| Treatment | 18 | 33.7 ± 14.5 | 15.4 ± 14.1 | −18.4 | −15.2 | 0.9 | |||
| Total | 34 | 34.7 ± 16.8 | 21.6 ± 17.8 | −12.8 | −18.0 | −7.5 | |||
| ESS | Control | 15 | 10.2 ± 4.9 | 9.6 ± 5.2 | −0.6 | −2.5 | 1.3 | } | 0.010 |
| Treatment | 20 | 10.6 ± 4.4 | 6.2 ± 2.9 | −4.4 | −6.4 | −2.3 | |||
| Total | 35 | 10.4 ± 4.5 | 7.7 ± 4.3 | −2.5 | −3.9 | −1.1 | |||
| Snoring score: patient’s assessment | Control | 14 | 5.4 ± 2.7 | 5.2 ± 2.5 | −0.2 | −2.0 | 1.6 | } | 0.001 |
| Treatment | 15 | 6.1 ± 2.3 | 1.5 ± 1.8 | −4.5 | −6.1 | −3 | |||
| Total | 29 | 5.8 ± 2.5 | 3.3 ± 2.8 | −2.4 | −3.5 | −1.2 | |||
| Snoring score: bed partner’s assessment | Control | 9 | 7.4 ± 1.1 | 6.7 ± 2.4 | −0.8 | −2.9 | 1.3 | } | 0.001 |
| Treatment | 16 | 8.3 ± 1.2 | 3.0 ± 2.7 | −5.4 | −7.0 | −3.7 | |||
| Total | 25 | 8.0 ± 1.2 | 4.3 ± 3.1 | −3.1 | −4.4 | −1.8 | |||
| AI | Control | 15 | 27.9 ± 22.7 | 23.0 ± 19.8 | −5.0 | −13.5 | 3.5 | } | 0.10 |
| Treatment | 16 | 22.3 ± 16.0 | 13.6 ± 22.6 | −8.7 | −23.0 | 5.6 | |||
| Total | 31 | 25.0 ± 19.4 | 18.1 ± 21.5 | −6.9 | −15.0 | 1.2 | |||
| HI | Control | 15 | 7.0 ± 7.3 | 5.2 ± 8.6 | −1.8 | −5.7 | 2.1 | } | 0.79 |
| Treatment | 16 | 11.0 ± 9.5 | 6.7 ± 8.1 | −4.3 | −10.7 | 2.1 | |||
| Total | 31 | 9.0 ± 8.6 | 6.0 ± 8.2 | −3.1 | −6.7 | 0.6 | |||
| RDI | Control | 16 | 36.7 ± 19.0 | 28.7 ± 19.4 | −8.1 | −16.5 | 0.3 | } | 0.27 |
| Treatment | 17 | 34.3 ± 14.8 | 21.8 ± 21.8 | −12.5 | −25.6 | 0.5 | |||
| Total | 33 | 35.5 ± 16.7 | 25.1 ± 20.7 | −10.3 | −17.9 | –2.8 | |||
| RERA | Control | 16 | 24.5 ± 23.5 | 24.5 ± 22.5 | 0.0 | −8.7 | 8.7 | } | 0.117 |
| Treatment | 16 | 22.3 ± 25.2 | 14.3 ± 20.2 | −8.0 | −13.9 | –2.1 | |||
| Total | 32 | 23.4 ± 24.0 | 19.4 ± 21.6 | −4.0 | −9.1 | 1.0 | |||
| Ø SpO2 | Control | 16 | 90.8 ± 5.1 | 91.7 ± 4.6 | 0.9 | −0.6 | 2.5 | } | 0.136 |
| Treatment | 17 | 89.1 ± 7.1 | 92.9 ± 5.5 | 3.8 | 0.2 | 7.4 | |||
| Total | 33 | 89.9 ± 6.2 | 92.3 ± 5.0 | 2.4 | 0.5 | 4.3 | |||
| min. SpO2 | Control | 16 | 79.3 ± 9.4 | 83.4 ± 8.7 | 4.0 | −0.3 | 8.3 | } | 0.946 |
| Treatment | 17 | 79.4 ± 9.8 | 83.7 ± 7.1 | 4.2 | −1.5 | 10 | |||
| Total | 33 | 79.4 ± 9.4 | 83.5 ± 7.8 | 4.1 | 0.6 | 7.6 | |||
| SpO2T90 | Control | 16 | 11.6 ± 19.3 | 10.2 ± 18.2 | −0.8 | −2.9 | 1.3 | } | 0.079 |
| Treatment | 17 | 7.8 ± 9.2 | 1.6 ± 2.6 | −5.4 | −7.0 | –3.7 | |||
| Total | 33 | 9.7 ± 14.9 | 5.8 ± 13.3 | −3.1 | −4.4 | –1.8 | |||
*Case number, mean, standard deviation, and mean difference are stated with 95% confidence intervals. The mean difference is based on estimated marginal means. The “p-value” column gives the significance of the variance analysis of the interaction “time × group.” Calculation of p-values for AI, HR, RDI, and SPO2T90 is based on log-transformed variables.95% CI: 95% confidence interval; AHI: Apnea–Hypopnea Index; AI: Apnea Index; ESS: Epworth Sleepiness Scale; HI: Hypopnea Index; Surgery; RDI: Respiratory Disturbance Index; RERA: Respiratory effort-related arousal; SPO 2 #: Oxygen saturation; SPO 2 T 90 : Percentage of total sleep time with oxygen saturation below 90%