Table 3: Description of RCTs comparing MAS to placebo oral appliances for the treatment of OSA.
Study | Inclusion criteria | N (# males) | Mean Age |
Mean BMI |
Duration of study (wash out period) |
---|---|---|---|---|---|
Petri et al. 2008 (8) Parallel arm study |
AHI >5 >20 years Sufficient teeth to hold splint All patients offered CPAP, but chose oral appliances |
93 (76) (12 dropouts) (29 in no intervention arm) |
50 (SD 10) |
31.3 (SD 1.3) |
4 weeks (NA) |
Blanco et al. 2005 (9) Parallel arm study |
≥2 OSA symptoms AHI ≥10 Exclude BMI >40 |
24 (20) (9 dropouts) |
53.5 (SD 13.5) |
26.8 (SD 2.8) |
3 months (NA) |
Barnes et al. 2004 (10) Crossover study |
Adequate dentition AHI 5−30 |
114 (91) | 47 (SD 9.6) |
31.1 (SD 5.3) |
3 months (2 weeks) |
Gotsopoulos et al. 2004 (11-13)* Crossover study |
RDI >10/h At least 2 OSA symptoms 20 years Ability to protrude mandible at least 3 mm |
73 (59) | 48 (SD 11) |
29.0 (SD 4.7) |
4 weeks (1 week) |
Johnston et al. 2002 (14) Crossover study |
AHI >10/h Absence of concurrent serious illness |
21 (16) (1 drop out) |
55.1 (SD 6.9) |
31.6 (SD 5.9) |
4−6 weeks (NR) |
Mehta et al. 2001 (15) Crossover study |
AHI >10/h At least 2 OSA symptoms |
28 (22) (4 dropouts) |
48 (SD 9) |
29.4 (SD 3.1) |
1 week (1 week) |
Note: BMI, body mass index; CI, confidence interval; NA, not applicable; NR, not reported; RDI, respiratory distress index; SD, standard deviation
The same group of authors published results for a RCT between 2002-2005.