Table 5: ESS reported in RCTs comparing MAS to placebo oral appliances for the treatment of OSA.
| Study | Treatment | Baseline ESS |
Follow-up ESS |
Mean difference between baseline and follow-up |
Mean difference between MAS and Placebo |
Clinical significance |
|---|---|---|---|---|---|---|
| Petri et al. 2008 (8) Parallel arm study (N=93) |
MAS Placebo |
11.7 SD 4.3 10.8 SD 4.6 |
8.4 SD 4.3 9.6 SD 4.2 |
3.3 P<.001 1.2 P=0.5 |
−1.2 P=.044 |
Yes No |
| Blanco et al. 2005 (9) Parallel arm study (N=15) |
MAS Placebo |
14.7 SD 5.1 16.3 SD 2.5 |
5.1 SD 1.9 13.6 SD 6.7 |
9.6 P <.05 2.7 NS (no value reported) |
−8.5 NR |
Yes No |
| Barnes et al. 2004 (10) Crossover study (N=80) |
MAS Placebo |
10.7 SD 3.6 10.7 SD 3.6 |
9.2 SD 3.6 10.2 SD 3.6 |
1.5 P<.001 0.5 NS (no value reported) |
−1.0 P<.001 P <.001 |
Yes No |
| Gotsopoulos et al. 2004 (11-13)* Crossover study (N=73) |
MAS Placebo |
10.9 SD 4.8 10.9 SD 4.8 |
7.1 SD 4.5 9.1 SD 5.1 |
3.8 NR 1.8 NR |
−2.0 P<.01 |
Yes Yes |
| Johnston et al. 2002 (14) Crossover study (N=20) |
MAS Placebo |
13.9 SD 6.4 13.9 SD 6.4 |
11.6 SD 6.7 12.6 SD6.7 |
2.3 NR 1.3 NR |
−1.0 P=.41 |
No No |
| Mehta et al. 2001 (15) Crossover study (N=24) |
MAS Placebo |
10.1 SD 5.4 10.1 SD 5.4 |
3.9 SD 2.9 NR |
6.2 P<.01 N/A |
N/A | Yes N/A |
Note: ESS, Epworth Sleepiness Scale; MAS, mandibular advancement splint; NR, not reported; SD, standard deviation
*
The same group of authors published results for a RCT between 2002-2005.