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An oral appliance with or without elastic bands to control mouth opening during sleep—a randomized pilot study

  • Sleep Breathing Physiology and Disorders • Original Article
  • Published:
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Abstract

Background

Oral appliances (OAs) hold the lower jaw forward to reduce obstructive sleep apneas. Some OA designs allow mouth opening, which influences the forward positioning of the lower jaw. The aim of this pilot study was to compare the efficacy of an adjustable, custom-made OA (Narval®) in its original design, which allowed mouth opening, with the same OA with elastic bands that restricted mouth opening.

Methods

Consecutive patients with an apnea-hypopnea index (AHI) of ≥15 were randomized to start with an OA either with or without elastic bands in a single-blinded, crossover, pilot study. The patients underwent acclimatization and titration. After 3 weeks use of each device, they had renewed sleep apnea recordings and responded to questionnaires. Washout periods took place between the tests.

Results

Ten subjects with a median AHI of 19.7 (interquartile range (IQR) 17.3 to 31.8) were included. The AHI decreased to 3.1 (IQR 1.5–14.7) (p < 0.01) with the OA and to 5.1 (IQR 2.4–14.3) (p < 0.01) with the OA with elastic bands, with no difference between them (p = 0.7). The two subjects with severe obstructive sleep apnea (OSA) almost halved their supine AHI with, as compared to without, elastic bands. The majority of the patients preferred to use the elastic bands.

Conclusions

This pilot study indicates that elastic bands markedly reduced the supine AHI in two subjects with severe sleep apnea as compared to without elastic bands. The majority of the patients preferred the use of elastic bands, although no significant difference in the AHI was observed with versus without the elastic bands in the whole sample.

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Abbreviations

AHI:

Apnea-hypopnea index

BMI:

Body mass index (kg/m2)

CI:

Confidence interval

CPAP:

Continuous positive airway pressure

ESS:

Epworth Sleepiness Scale

FOSQ:

Functional Outcomes of Sleep Questionnaire

IQR:

Interquartile range

KSS:

Karolinska Sleepiness Scale

OA:

Oral appliance

ODI:

Oxygen desaturation index

OSA:

Obstructive sleep apnea

VAS:

Visual analog scale

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Author information

Authors and Affiliations

  1. Department of Orthodontics, Umeå University, SE-901 87, Umeå, Sweden

    Niclas Norrhem & Marie Marklund

Authors
  1. Niclas Norrhem
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  2. Marie Marklund
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Corresponding author

Correspondence to Marie Marklund.

Ethics declarations

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Funding

The County Council of Västerbotten provided financial support in the form of grant funding. The sponsor had no role in the design or conduct of this research.

Conflict of interest

The authors declare that they have no competing interests.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

Comments:

Many custom-fabricated adjustable mandibular advancement devices (MADs) can be used without or with elastics between the upper and lower tray components to promote mouth closure during sleep. Dental sleep clinicians differ greatly in opinion as to the value of this design feature because remarkably, no research has addressed the efficacy of oral appliance therapy without versus with the elastics in place. The authors provide the first report on this very important clinical issue. Specifically, sleep apnea testing was performed without and with the elastics in place on the Narval mandibular advancement device for ten subjects using a randomized crossover design. Prior to data collection, each subject had been acclimatized to the appliance, without and with the elastics. The authors demonstrate that at least for some patients, appliance design features to keep the mouth closed, such as the elastics, improve the efficacy of oral appliance therapy.

Gregory Essick

NC, USA

The study was conducted at the Department of Odontology, Umeå University, Sweden, in collaboration with the Department of Public Health and Clinical Medicine, Umeå University.

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Norrhem, N., Marklund, M. An oral appliance with or without elastic bands to control mouth opening during sleep—a randomized pilot study. Sleep Breath 20, 929–938 (2016). https://doi.org/10.1007/s11325-016-1312-5

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  • DOI: https://doi.org/10.1007/s11325-016-1312-5

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