Elsevier

Sleep Medicine

Volume 12, Issue 9, October 2011, Pages 844-849
Sleep Medicine

Original Article
Mandibular advancement appliances remain effective in lowering respiratory disturbance index for 2.5–4.5 years

https://doi.org/10.1016/j.sleep.2011.05.004Get rights and content

Abstract

Objective

The mandibular advancement appliance (MAA) is now recognized as a first-line therapy option for mild to moderate obstructive sleep apnea syndrome (OSAS). The aim of this follow-up study was to re-assess the long-term efficacy of MAAs provided to patients in a previous comparative study.

Methods

Sixteen subjects had participated in a previous comparative study in which the efficacy and compliance of two MAAs (Klearway – K and Silencer – S) were compared in a randomized cross-over design. At the end of the previous comparative study, subjects selected the MAA they preferred. Nine chose the K and seven the S. Fifteen subjects were available for a follow-up interview and 14 (4 women and 10 men; mean ± SEM: 51.9 ± 1.7 y.o.) agreed to participate in an overnight sleep recording at a hospital sleep laboratory from January to February 2009. The mean time lag between the end of the previous comparative study and the follow-up was 40.9 ± 2.1 months (range of 2.5–4.5 years). Comparisons were made across the three polysomnographic evaluations (PSGE): baseline, the night with the appliance of their choice at the end of the previous comparative study, and the follow-up night. Subjects completed the Epworth sleepiness scale (ESS), the fatigue severity scale (FSS), and a quality of life questionnaire (FOSQ).

Results

At the follow-up, the respiratory disturbance index (RDI) remained significantly lower than baseline (p < 0.001). Questionnaire responses revealed that ESS, FSS, and FOSQ remained improved at follow-up (p < 0.02). Body mass index (BMI) increased slightly from baseline to follow-up (p < 0.05). Diastolic and systolic blood pressure and cardiac rhythm decreased significantly from baseline to follow-up.

Conclusions

The MAAs remained effective in improving RDI, sleepiness, blood pressure, cardiac rhythm, fatigue, sleep quality, and quality of life over a period of 2.5–4.5 years. The rise in BMI is a concern that merits further examination.

Introduction

Although continuous positive airway pressure (CPAP) is the gold standard treatment for obstructive sleep apnea syndrome (OSAS), many studies have demonstrated the efficacy of the mandibular advancement appliance (MAA) in the management of mild to moderate OSAS [1], [2], [3], [4]. The MAA is now recognized as a first-line therapy option in the presence of snoring and mild to moderate OSAS with moderate symptoms [5].

The majority of long-term follow-up studies involving an MAA focus on tooth displacement and/or skeletal changes [6], [7], [8], [9], [10], [11], [12], [13], [14], [15], [16], [17]. Few studies on subjects with mild to moderate OSAS have reported long-term follow-up (from 1 to 5 years) on MAA efficiency in terms of reduced respiratory disturbance index (RDI), blood pressure, and cardiac rhythm, or improved subjective symptoms such as sleepiness, quality of life, sleep quality, and subject’s and bed partner’s satisfaction [18], [19], [20], [21], [22], [23], [24].

The aim of this follow-up study was to assess whether the previously reported [25] efficacy (RDI, physiological variables such as blood pressure and cardiac rhythm) and patient’s subjective appreciation (sleep quality, quality of life and symptoms) of the two MAA had remained stable, improved, or deteriorated over time.

Section snippets

Subjects

Of the 16 subjects who participated in a previous controlled study comparing two MAA in a randomized cross-over design [25], 15 were still using the MAA they preferred at the end of the previous comparative study and were available for a clinical follow-up. Subjects signed an informed consent form approved by our hospital’s Institutional Ethics Review Board. One refused and 14 agreed to participate in a single night of polygraphic recording. The 14 subjects (4 women, 10 men) had a mean age of

RDI, oxymetry and blood pressure

RDI remained low at the follow-up night recording compared to baseline (p < 0.001) with no significant difference from the night at the end of the previous comparative study (p = 0.2) (Fig. 1, Table 1).

We also observed that 10 of the 14 subjects suffered from positional sleep apnea at the baseline night. This ratio was reduced to 8/14 at the end of the previous comparative study and 6/14 at the follow-up. We then decided to assess positional RDI. RDI in supine position was reduced from the baseline

Discussion

This follow-up study confirms that both the Klearway and the Silencer remained effective in reducing RDI at the end of the previous comparative study. In the long term, and on average, subjects with mild OSAS showed stable RDI and improvements in both total and supine indexes.

Among the positive outcomes were the reduction in percentage of REM sleep and increased stage 3–4 sleep. The negative outcomes were reduced TST with consequent reduced sleep efficiency. The reduced total sleep time and

Conclusion

The results of this study show that both types of MAA are indicated in the long-term management of mild to moderate OSAS. Improvements in RDI, subjective symptoms, quality of life and sleep, systolic and diastolic blood pressure, and cardiac rhythm were observed in relation to a BMI increase, and further assessment is needed.

Conflict of interest

The ICMJE Uniform Disclosure Form for Potential Conflicts of Interest associated with this article can be viewed by clicking on the following link: doi:10.1016/j.sleep.2011.05.004.

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Acknowledgments

The authors would like to thank Christiane Manzini, Carmen Remo and the entire staff at the Laboratoire de sommeil du Centre de Santé et des Services Sociaux de Chicoutimi (particularly Anny Blackburn, Nadya Michaud, Hélène Bouchard, Marie-Claude Godin, Marie-Christine Duchesne and Julie Gaudreault) for technical support. We would also like to thank CIHR (Grant to Dr. Gilles Lavigne), the Fond de l’Ordre des dentists du Québec-FRSQ, the Ministère des Transports du Québec and Sogedent for

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