The Research Behind SleepPro | TOMADO Trial
The research behind SleepPro
Most anti-snoring devices ask you to take their word for it. SleepPro's mandibular advancement devices have been examined in independent clinical research.
SleepPro devices were among those assessed in TOMADO — the Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea-hypopnoea — a randomised controlled trial funded by the UK's National Institute for Health Research (NIHR) and published in the respiratory journal Thorax in 2014.
The trial compared three mandibular advancement devices against no treatment in 90 adults with mild-to-moderate obstructive sleep apnoea-hypopnoea. Two of the three were SleepPro devices made by Meditas Ltd: the self-moulded SleepPro 1 and the semi-bespoke SleepPro 2 — the device behind today's Custom range.
Its published conclusions were that mandibular advancement devices are clinically effective and cost-effective in mild-to-moderate obstructive sleep apnoea, and that a semi-bespoke device — the SleepPro 2 — is an appropriate first choice for most patients in the short term. The trial also found that a well-fitted, individually made device was better tolerated than a basic self-mould, which in turn helped people keep using it.
Snoring, sleep apnoea, and when to see a clinician
Snoring on its own is common and usually harmless. But it can sometimes be a sign of obstructive sleep apnoea (OSA), a condition where breathing is repeatedly interrupted during sleep. OSA needs to be diagnosed by a clinician, usually with a sleep study.
If you snore heavily, wake unrefreshed, feel very sleepy during the day, or have been told you stop breathing in your sleep, speak to your GP before relying on any oral device. Where a mandibular advancement device is suitable for mild-to-moderate OSA, that's a decision best made with your GP, dentist or sleep clinic — and SleepPro's Custom range is designed for exactly that use, under professional guidance.
Reference
Quinnell TG, Bennett M, Jordan J, et al. A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO). Thorax 2014;69(10):938–945. Trial registration ISRCTN02309506. Funded by the NIHR Health Technology Assessment programme.
https://thorax.bmj.com/content/69/10/938
https://www.journalslibrary.nihr.ac.uk/hta/HTA18670
A custom MAD manufactured by Meditas is also the device used in the ongoing PAPMAT study at Royal Papworth Hospital, which is investigating whether combining CPAP with an MAD can help certain higher-pressure patients tolerate therapy better. PAPMAT is funded as a non-commercial NHS / NIHR clinical trial.
https://www.isrctn.com/ISRCTN33966032
These and other studies support the use of custom mandibular advancement devices as an evidence-based option for snoring and for some people with mild–moderate obstructive sleep apnoea.