Table 4: AHI reported in RCTs comparing MAS to placebo devices for the treatment of OSA.
| Study | Treatment | Baseline AHI (h) | Follow-up AHI (h) |
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 |
39.1 SD 23.8 32.6 SD 22.0 |
25.0 SD 27.5 31.7 SD 25.0 |
14.1 P <.001 0.9 P=.69 |
−6.7 P<.001 |
No No |
| Blanco et al. 2005 (9) Parallel arm study (N=15) |
MAS Placebo |
33.8 SD 14.7 24.0 SD 12.2 |
9.6 SD 12.1 11.7 SD 7.9 |
24.2 P <.01 12.3 P=.05 |
−2.1 NR |
Yes No |
| Barnes et al. 2004 (10) Crossover study (N=80) |
MAS Placebo tablet |
21.3 SD 13.9 21.3 SD 13.9 |
14.0 SD 11.7 20.3 SD 11.7 |
7.3 P <.001 1.0 P= NS (no value reported) |
−6.2 P<.001 |
No No |
| Gotsopoulos et al. 2004 (11-13)* Crossover study (N=73) |
MAS Placebo |
26.9 SD 15.4 26.9 SD 15.4 |
12.2 SD 12.3 25.4 SD 14.5 |
14.7 NR 1.5 P=NS (no value reported) |
−12.3 NR |
Yes No |
| Johnston et al. 2002 (14) Crossover study (N=20) |
MAS Placebo |
31.9 SD 21.2 31.9 SD 21.2 |
22.9 SD 22.8 37.7 SD 24.9 |
9.0 NR −5.8 NR |
−14.8 P=.011 |
No No |
| Mehta et al. 2001 (15) Crossover study (N=24) |
MAS Placebo |
27.0 SD17.0 27.0 SD 17.0 |
14.0 SD 9.8 30.0 SD 9.8 |
13.0 NR −3.0 P=NS (no value reported) |
−16.0 P<.0001 |
No No |
Note: AHI, apnea hypopnea index; MAS, mandibular advancement splint; NR, not reported; SD, standard deviation
*
The same group of authors published results for a RCT between 2002-2005.