Elsevier

Sleep Medicine

Volume 10, Issue 3, March 2009, Pages 329-336
Sleep Medicine

Original Article
Efficacy of two mandibular advancement appliances in the management of snoring and mild-moderate sleep apnea: A cross-over randomized study

https://doi.org/10.1016/j.sleep.2008.03.011Get rights and content

Abstract

Background

Mandibular advancement appliances (MAA) are a recognized alternative treatment to continuous positive airway pressure (CPAP) for mild-moderate obstructive sleep apnea syndrome (OSAS). The aim of this study is to assess the efficacy of and subject satisfaction with two MAA in the management of OSAS.

Methods

Five women and 11 men (47.9 ± 1.6 years), previously untreated with CPAP, were recruited from a sleep disorders clinic following a polysomnographic diagnosis of mild-moderate OSAS with Respiratory Disturbance Index (RDI) of 9.4 ± 1.1. A randomized single blind cross-over study was completed with both Klearway and Silencer (three months for each study arm). Subjects completed standardized questionnaires on sleep quality, sleepiness and functional outcomes (Functional Outcome Sleep Questionnaire: FOSQ). MAA satisfaction (e.g., comfort) and efficacy (e.g., reduction of respiratory noises, headache) were assessed by subjects and sleep partner.

Results

The two MAA (Silencer 4.7 ± 0.9 and Klearway 6.5 ± 1.3) significantly reduced the RDI compared to the baseline night (10.0 ± 1.2, respectively p < 0.001 and p < 0.01). The RDI was slightly lower with the Silencer (p  0.05) but subjects’ preference for comfort was in favor of the Klearway (Klearway 7.0 ± 0.4 vs Silencer 5.8 ± 0.4, p = 0.04). The Epworth score, FOSQ, respiratory noise and morning headache were also improved following use of both appliances (p  0.05 to 0.001).

Conclusion

Although both MAA decreased RDI and subjective daytime sleepiness in a similar manner, the choice between various types of MAA needs to be taken into account when considering the benefit of RDI reduction over the benefit of subject compliance. The long term benefit of increased RDI reduction vs. a better subject compliance needs to be assessed in prospective studies.

Introduction

Mandibular advancement appliances (MAA) are indicated in the treatment of snoring and mild-moderate obstructive sleep apnea syndrome (OSAS) [1], [2]. Although many studies have demonstrated the efficacy of MAA in the management of OSAS [3], [4], [5], [6], [7], Continuous Positive Airway Pressure (CPAP) is recognized as the “gold standard.” Yet, MAA remain a valid alternative preferred by several subjects [7], [8], [9].

Surprisingly few studies have compared the efficiency of two MAA using the apnea/hypopnea index (AHI) or the respiratory disturbance index (RDI) or even patient or sleep partner satisfaction as outcomes [10], [11], [12], [13], [14], [15], [16]. Also, most of these studies include a large range of severity, from very mild to highly severe OSAS subjects.

The present study aimed to assess the efficacy and patient/sleep partner satisfaction with two MAA in subjects with mild-moderate RDI (apnea + hypopnea + respiratory effort-related arousal per hour of sleep, RERA). The null hypothesis is that the Klearway is equivalent to the Silencer for the management of OSAS patients. The alternative hypothesis is that one appliance is superior.

Section snippets

Study design, population and inclusion/exclusion criteria

In a prospective, single blind cross-over and randomized study comparing two MAA, sleep and respiratory data were collected over a total of four nights (Fig. 1). The four sleep laboratory polygraphic recording (SLPR) nights were for OSAS diagnosis (N1), baseline (N2) and MAA assessment (N3 and N4). Subjects were enrolled for a six-month period (three months for each MAA arm between June 2004 and October 2006) and a follow-up interview one to two years after N2.

The subjects were recruited from

Results

The final sample of subjects who completed the full sequence comprised five women and 11 men aged 47.9 ± 1.6 years (range 37–60), with a body mass index (BMI) of 28.7 ± 0.8 kg/m2 (range 24–35), and a neck circumference of 39.8 ± 0.8 cm (range 35–49) with a mean RDI at N1 of 9.4 ± 1.1 (range 5–21). It can be noted that there was no significant difference for the BMI and neck circumference from N2 to N3 to N4. Moreover, seven subjects had no medical problems. Of the nine others, six suffered from

Discussion

The present study confirms that both the Klearway and Silencer are effective but similar in their capacity to reduce RDI in a population of subjects with mild-moderate OSAS, previously untreated with CPAP. Moreover, subjects’ sleep quality and quality of life were significantly improved.

The slight but significant advantage of the Silencer needs to be interpreted with caution since the N2 mean RDI baseline index per hour of sleep is low (10 RDI) with a 12% standard error (Table 1). Both

Conclusion

The present results confirm that both types of MAA are indicated in the management of mild-moderate OSAS. Since both MAA decreased RDI and subjective daytime sleepiness in a similar manner, the choice of an oral appliance needs to be weighted giving due consideration to the benefit of RDI reduction (in favor of the Silencer) over benefit of subject compliance (in favor of the Klearway). The long term benefit of a better RDI reduction vs. a better patient compliance needs to be assessed in

Acknowledgments

The authors thank Christiane Manzini, Carmen Remo, Hajar El Alaoui and the whole staff at the Laboratoire de sommeil du Centre de Santé et des Services Sociaux de Chicoutimi (particularly Annie Blackburn, Nadia Michaud, Marie-Christine Duchesne and Claude Fortin) for their technical support and CIHR, FODQ-FRSQ and Ministère des Transport du Québec & Sogedent for their financial support.

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    Conflict of interest: Dr. G.J. Lavigne was a consultant for Respironics, USA and Wyeth Consumer Healthcare, Canada. The study did not receive financial support from any manufacturer of dental appliances.

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