A randomised controlled crossover trial comparing two mandibular repositioning appliances for treatment of moderate obstructive sleep apnoea.
Jorden Blok, Zoë Van Houtvinck, Susie Klerkx et al.
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In 30 seconds
This single-centre, randomised two-period crossover trial compared two custom-made mandibular repositioning appliances in 16 adults with moderate obstructive sleep apnoea. Each appliance was worn for three months, separated by a two-week washout. Median AHI decreased from 17.6 events/h at baseline to 3.1 with SomnoDent Flex and 2.3 with NOA (both p < 0.001 versus baseline). The non-prespecified comparison found a between-appliance difference of + 0.16 events/h (95% CI - 2.56 to + 2.87; p = 0.904), which does not establish equivalence.
Key findings
- Median AHI fell from 17.6 events/h at baseline to 3.1 with SomnoDent Flex and 2.3 with NOA; both reductions had p < 0.001 versus baseline.
- The between-appliance difference was + 0.16 events/h (95% CI - 2.56 to + 2.87; p = 0.904); the analysis did not establish equivalence.
- A period effect of + 3.82 events/h occurred in period 2, when measurement changed from home polygraphy to in-laboratory polysomnography (p = 0.009).
- Post hoc, AHI < 5 events/h was reached in 12/16 participants with SomnoDent Flex and 10/16 with NOA.
Why it matters
Both appliances were associated with substantial reductions in AHI in this small trial, suggesting that either may reduce measured disease severity in adults with moderate OSA. However, the comparison cannot show that the appliances perform equivalently. The period effect and change in measurement method also complicate interpretation, so the findings offer limited certainty about their comparative merits.
What to keep in mind
The trial included only 16 participants at one centre. Measurement method changed between periods, completely confounding period with methodology. Adherence, titration and adverse events were insufficiently assessed; adverse events were not systematically recorded.