Pilot study of a novel mandibular advancement device for the control of snoring.
OBJECTIVE
Mandibular advancement devices (MADs) have been introduced as a conservative, non-invasive treatment for socially disturbing snoring and mild obstructive sleep apnea (OSA). A prospective, non-randomized pilot study was conducted to investigate the efficacy, feasibility, side-effects and compliance of Somnoguard, an immediately intraorally adaptable MAD made from thermoplastic material.


METHODS
Twenty consecutive heavy snorers with a respiratory disturbance index of <20 events/h were prospectively selected. Prior to the adaptation of the appliance, ambulatory polygraphy was carried out without a MAD. After a 1-month habituation period, a polygraphic evaluation was carried out with the device. Treatment success was defined as a reduction in the apnea-hypopnea index (AHI) of at least 50%.


RESULTS
The results indicated a success rate of 65%. The AHI decreased from 8.4 +/- 2.9 events/h at baseline to 3.9 +/- 1.8 events/h with the device (p = 0.001). At 1-month follow-up, significant reductions in the snoring index (p < 0.001) and the Epworth Sleepiness Scale (ESS) score (p = 0.036) were noted. At 6-month follow-up, similar results were achieved, with significant drops in the snoring index (p = 0.025) and ESS score (p = 0.033).


CONCLUSIONS
We conclude that immediate intraoral adaptation of a low-cost fabricated "one-size-only" MAD is a feasible and well-tolerated treatment for snoring and mild OSA. Further research is needed to evaluate this thermoplastic appliance as a strategy to "screen" the efficacy of MAD treatment in the individual patient with a less expensive appliance before constructing a more expensive custom-made MAD.
Vanderveken
Olivier M
OM
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital, University of Antwerp, Antwerp, Belgium. olivier.vanderveken@uza.be
Boudewyns
An N
AN
Braem
Marc J
MJ
Okkerse
Walter
W
Verbraecken
Johan A
JA
Willemen
Marc
M
Wuyts
Floris L
FL
De Backer
Wilfried A
WA
Van de Heyning
Paul H
PH
D000328:Adult; D000368:Aged; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D019186:Mandibular Advancement / Q000295:instrumentation*; D008875:Middle Aged; D010349:Patient Compliance; D017060:Patient Satisfaction; D010865:Pilot Projects; D010969:Plastics; D017286:Polysomnography; D011446:Prospective Studies; D012913:Snoring / Q000628:therapy*; D016896:Treatment Outcome
D010969:Plastics