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Randomized Controlled Trial
. 2015 May;19(2):637-44.
doi: 10.1007/s11325-014-1068-8. Epub 2014 Oct 22.

A promising concept of combination therapy for positional obstructive sleep apnea

Marijke Dieltjens  1 , Anneclaire V Vroegop, Annelies E Verbruggen, Kristien Wouters, Marc Willemen, Wilfried A De Backer, Johan A Verbraecken, Paul H Van de Heyning, Marc J Braem, Nico de Vries, Olivier M Vanderveken
Affiliations
Randomized Controlled Trial

A promising concept of combination therapy for positional obstructive sleep apnea

Marijke Dieltjens et al. Sleep Breath. 2015 May.

Abstract

Purpose: The objective of this randomized controlled trial was to assess the additional effect of a chest-worn sleep position trainer (SPT) in patients with residual supine-dependent obstructive sleep apnea (sdOSA) under mandibular advancement device (MAD) therapy.

Methods: Baseline and follow-up polysomnography with MAD were performed. Twenty patients with sdOSA under MAD therapy underwent two consecutive randomized polysomnographies: one with SPT and one with combination of SPT + MAD. Data are presented as median (quartile 1, quartile 3).

Results: The SPT reduced the time spent in supine sleeping position compared to baseline and MAD therapy. Both MAD and SPT were individually effective in reducing the overall apnea/hypopnea index (AHI) significantly when compared to baseline from 20.8 (15.1; 33.6)/h at baseline to 11.0 (6.7; 13.8)/h and to 11.1 (3.5; 17.7)/h with MAD or SPT, respectively. The combination of SPT + MAD further reduced the overall AHI to 5.7 (3.6; 7.4), which was significantly lower than with MAD alone (p < 0.001) and SPT alone (p < 0.008), respectively.

Conclusions: The results of this study indicate that combination of SPT + MAD leads to a higher therapeutic efficacy in patients with sdOSA under MAD therapy when compared to one of the treatment modalities alone.

Trial registration: ClinicalTrials.gov NCT01535521.

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Figures

Fig. 1
Fig. 1
Flow chart of the study design
Fig. 2
Fig. 2
The sleep position trainer used in this study
Fig. 3
Fig. 3
Percentages of total sleep time spent (TST) in the supine position for the different study nights
Fig. 4
Fig. 4
Overall apnea/hypopnea index (AHI) for the different conditions tested. The different gray scales represent the varying levels of sleep apnea severity, ranging from normal nocturnal breathing (AHI <5/h sleep), mild OSA (AHI 5–15/h), moderate OSA (AHI 15–30/h), to severe OSA (AHI >30/h). Left panel: Box plots for the four different study nights. The 75th and 25th percentiles are represented by the upper and lower margins, the mean values by the closed dots, and the median values by the horizontal line. Whiskers represent the maximum value (top) and the minimum value (bottom) of the dataset. Outliers are represented by an open dot. Right panel: The individual patient data for the different study nights are plotted in line graphs
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