Fleetham 1998.
| Methods | Randomised, prospective, unblinded parallel group study comparing oral appliance with nasal CPAP. Study duration 3 months | |
| Participants | 101 patients were recruited. Inclusion criteria AHI>10. 51 participants were randomised to receive CPAP and 50 were randomised to receive OA therapy. 96 men were recruited. Baseline demographics: AHI: CPAP: 37.6 +/‐22.8; OA: 38.7 +/‐22.2. Min SaO2: CPAP: 75.8 +/‐12.7; OA: 73.6 +/‐11.8. Age: CPAP: 49.0 +/‐9.4; OA: 46.2 +/‐11.3. ESS: CPAP: 12.8+/‐4.1; OA: 11.1 +/‐4.9. BMI: CPAP: 32.0 +/‐5.5; OA: 31.4 +/‐5.7. SAQLI: CPAP: 4.2 +/‐1.1; OA: 4.2 +/‐1.0. |
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| Interventions | Participants were randomised to either oral appliance or nCPAP for a period of three months. | |
| Outcomes | AHI, Epworth sleepiness score, minimum SaO2, Quality of life index. | |
| Notes | Jadad score 1 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | Described as randomised, other information not available |
| Allocation concealment? | Unclear risk | Information not available |
| Blinding? All outcomes | High risk | OA and CPAP compared |