Table 2: Quality of studies in review of oral appliances.
Study | Study design | Randomization method | Blinding | Intent-to-treat | Adequate sample size |
---|---|---|---|---|---|
MAS versus Placebo Devices | |||||
Petri et al. 2008 (8) | 3-armed, parallel group design | Computer generated | Yes§ | No | Yes |
Blanco et al. 2005 (9) | Parallel group design | Unclear | No | No | Unclear |
Barnes et al. 2004 (10)* | Randomized crossover study (3 arm) | Random draw | No | No | Yes |
Gotsopoulos et al. 2004 † (11-13) | Randomized crossover study | Unclear | Yes | Yes | Unclear |
Johnston et al. 2002 (14) | Randomized crossover study | Unclear | No | No | Yes |
Mehta et al. 2001 (15) | Randomized crossover study | Unclear | No§ | No | Unclear |
MAS versus CPAP | |||||
Hoekema et al. 2008 † (16-19) | Parallel group design, Non-inferiority | Block randomization | No | Yes | Yes |
Lam et al. 2007 (20) | Parallel group design | Unclear | No | Yes | Yes |
Barnes et al. 2004 (10)* | Randomized crossover study (3 arm) | Random draw | No | No | Yes |
Engleman et al. 2002 (21) | Randomized crossover study | Balanced blocks of 4 stratified by OSA severity | No | No | Yes |
Randerath et al. 2002 (22) | Randomized crossover study | Unclear | No | N/A | Unclear |
Tan et al. 2002 (23) | Randomized crossover study | Unclear | No | Yes | Unclear |
Ferguson et al. 1997 (24) | Randomized crossover study | Unclear | No | No | Unclear |
Ferguson et al. 1996 (25) | Randomized crossover study | Unclear | No | No | Unclear |
MAS versus Surgery | |||||
Walker-Engstrom et al. 2002 † (26-30) | Parallel group design | Closed envelope system | No | Inconsistent | Yes |
Tongue Repositioning Devices | |||||
Deane et al. 2009 (in press) (31) | Randomized crossover study | Unclear | No | No | Yes‡ |
Dort et al. 2008 (32) | Randomized crossover study | Block randomization | Unclear | No | Unclear |
Barnes et al was a 3-arm trial that compared MAS, CPAP and placebo tablet.
These trials were reported in multiple publications.
The study was powered to detect difference between baseline and endpoints, not between group differences.
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