A combination appliance for obstructive sleep apnea: the effectiveness of mandibular advancement and tongue retention. The study was approved by the Conjoint Ethics Committee of the University of Calgary and written informed consent was obtained from all participants.Oral AppliancesAn MRA (EMA)31 was custom-made for each patient. These devices have been previously found to reduce the RDI by ≥ 50% in 34% of subjects and to control snoring in 73% of subjects13 (Figure 1). The timing of the tests was dependent on the individual's ability to acclimate to a particular test condition.Portable MonitoringThe RDI and oxygen parameters were assessed at baseline and each of the 4 study conditions using a portable monitor (Sagatech, Calgary, Canada) that digitally records oxygen saturation, heart rate with a pulse oximeter, snoring sounds with a microphone, and body position with a gyroscope. An off-line algorithm analyzes the nocturnal oxygen saturation signal to determine the RDI. Subjects were instructed to use the sleep monitors only while the appliances were in use and to turn off the monitors when they removed the appliance.Study DesignThis study employed a prospective repeated measures design, in which each subject acted as his own control.
Patients who agreed to participate underwent clinical evaluation including impressions for dental study models.
Subjects were seen in the dental clinic as they progressed through the 4 study stages: 6-mm protrusion, 8-mm protrusion, 6-mm protrusion with tongue device, and 8-mm protrusion with tongue device. A subject's final outcome was the study stage furthest along the sequence they were able to tolerate comfortably during nightly use.Outcome MeasuresThe primary outcome measure was the reduction in RDI as subjects progressed through the study stages. The ESS is a questionnaire commonly used to assess daytime sleepiness.34Statistical AnalysisMixed regression modeling was used to examine mean RDI under the various study conditions. Mixed regression modeling for repeated measures was chosen as appropriate as the sleep tests at each stage were carried out at different times for the individual subjects and not all individuals have observations at all stages. Forty-one subjects with moderate-to-severe OSA were studied at baseline and after each of 4 treatment stages.
Treatment stage predicted 66% of the variability in RDI.The decrease in RDI was statistically significant and represented a meaningful change in RDI from baseline to final stage.
Using the same response criteria, Deane16 reported complete or partial response in 71%, Mehta in 71%,36 and Gindre in 73%.37 The response in our study may have been limited by the design of the combination device.

Numerous studies have reported increased response with increased protrusion.23,24,37 Previous studies have allowed patients to advance (titrate) their appliances to maximum tolerable protrusion or symptom relief. Our subjects were only allowed a limited number of protrusion settingsMehta reports a mean acclimatization period of more than 19 weeks.36 While our subjects were not tested until they could tolerate the device for at least four hours of sleep at any particular stage, our entire study was conducted in less than 20 weeks. If subjects had a longer time to acclimate to the devices, they may have had a greater response.Patient preference was not predetermined as an outcome measure, but it is suggested by the number tested at each stage of the study.
Deane reported that subjects preferred the MRA to the TD and that more subjects removed the TD during sleep compared to the MRA (86% vs 9%).16 The design used in this study made the TD impossible to remove separately. If explored in future studies, the relationships between tongue volume in the TD and response could inform appliance design.Based on the findings of Sutherland, the response of the combination device can be considered in terms of the different expected effect on airway caliber produced by the individual components. The difference between response at 6-mm protrusion (20%) and 8-mm (44%) is consistent with improved response with titration found in previous studies.23,24,37 This difference could reflect the increase in response due to anterior displacement of the tongue base muscles.
If so, it could be of clinical significance to increasing response in those with limited mandibular protrusion.Our results may have been influenced by selection bias, as the study design was not randomized.
Portable monitors may produce an underestimation of the RDI, as electroencephalography is not used and the monitor is not able to record respiratory effort related arousals (RERAs). Practice parameters for the treatment of snoring and Obstructive Sleep Apnea with oral appliances: an update for 2005. Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea.
A randomized, controlled, crossover study of a noncustomized tongue retaining device for sleep disordered breathing. The tongue-retaining device: efficacy and side effects in obstructive sleep apnea syndrome.
Management of obstructive sleep apnea with a mandibular and tongue advancement splint (MTAS) in a completely edentulous patient. Comparison of mandibular advancement splint and tongue stabilizing device in obstructive sleep apnea: a randomized controlled trial.

Comparative effects of two oral appliances on upper airway structure in obstructive sleep apnea. Mandibular advancement devices in 630 men and women with obstructive sleep apnea and snoring: tolerability and predictors of treatment success. Factors related to the efficacy of an adjustable oral appliance for the treatment of obstructive sleep apnea. Physical findings in the upper airways related to obstructive sleep apnea in men and women.
Mandibular advancement and obstructive sleep apnoea: a method for determining effective mandibular protrusion. Remotely controlled mandibular positioner predicts efficacy of oral appliances in sleep apnea. Mandibular advancement titration for obstructive sleep apnea: optimization of the procedure by combining clinical and oximetric parameters.
Use of flow-volume curves to predict oral appliance treatment outcome in obstructive sleep apnea. Influence of nasal resistance on oral appliance treatment outcome in obstructive sleep apnea. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. Digital monitoring of sleep-disordered breathing using snoring sound and arterial oxygen saturation.

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