- Design
- Crossover clinical study
- Population
- 20 adults with OSA (AHI below 50) who had not adhered to CPAP
- Primary outcome
- Oxygen desaturation index, snoring and hypoxic burden on home sleep testing
- Effect
- Median ODI 13.6 untreated, 6.1 with appliance, 5.3 with CPAP (appliance vs CPAP p = 0.40)
Twenty adults with obstructive sleep apnoea confirmed by polysomnography (AHI below 50 events per hour), all of whom had not adhered to CPAP, were fitted with a mandibular advancement appliance made through a fully digital workflow. Each then had home sleep tests untreated, on CPAP and on the appliance, in a crossover design.
Median oxygen desaturation index fell from 13.6 events per hour untreated to 6.1 with the appliance and 5.3 with CPAP; the difference between treatments was not significant. Snoring, hypoxic burden and heart rate also did not differ, while mean oxygen saturation was slightly better on CPAP.
This is a small study, published in an orthodontic journal, and it used home tests rather than full polysomnography after treatment. It fits existing evidence that mandibular devices are a reasonable option for mild to moderate OSA, especially when CPAP is not used. It cannot show equivalence, and in severe OSA CPAP remains first line.
- Consider a mandibular advancement device for mild to moderate OSA when CPAP is not tolerated.
- Confirm efficacy with a sleep study on the device after titration.
- Refer to a dentist experienced in sleep appliances for fitting and follow-up.
- Keep CPAP as first line for severe OSA or marked daytime sleepiness.
- A device used every night may do more than CPAP used rarely.
Why it matters
CPAP intolerance often ends treatment altogether; a credible alternative keeps patients treated.
Don't overread it
Twenty patients and a non-significant difference cannot establish that the device is as good as CPAP.
The statistics, in plain English
A p value of 0.40 for the difference in desaturation index means no difference was detected, not that none exists. With only 20 people, the study could miss a clinically important gap.
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