Hoekema 2006.
Methods | Randomised parallel group trial of CPAP and OA. Study duration: 8 weeks. Method of randomisation: not clear. Blinding: not performed. | |
Participants | 103 participants. Local outpatient unit Inclusion criteria: >20 years; polysomnographically confirmed sleep apnoea; Exclusion criteria: Prior treatment for OSA; clearly reversible morphological airway abnormalities; endocrine dysfunction; severe cardia disease; periodic limb movement; extensive periodontal disease/tooth decay; active temporomandibular joint disease (including severe bruxism); restrictions in mouth opening or advancement of mandible; partial/complete edentulism (< 8 teeth in upper or lower jaw). |
|
Interventions | Oral appliance versus CPAP | |
Outcomes | Treatment success; ESS; AHI; FOSQ; SF‐36; HADS | |
Notes | Jadad score 3 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | 'The clinical epidemiologist (BS) for the study made computer‐generated randomization sequences, balancing for disease severity. The randomization sequences were used for selecting random permuted blocks with lengths of 2, 4, and 6 |
Allocation concealment? | Low risk | 'The randomization sequences were concealed and administered by Department of Oral and Maxillofacial Surgery staff. After each person’s serial number and diagnosis of disease severity were provided, the treatment was disclosed. Each serial number could be provided only once.' |
Blinding? All outcomes | High risk | OA and CPAP compared |