Abstract
Purpose
Selective upper-airway stimulation (UAS) is a novel therapy for patients with obstructive sleep apnea (OSA). The aim of this study was to compare changes in sleep architecture during the diagnostic polysomnography and the post-implantation polysomnography in UAS in patients with OSA.
Methods
Twenty-six patients who received a UAS device (Inspire Medical Systems) were included. Treatment outcome was evaluated 2 and 3 months after surgery. Data collection included demographics, body mass index (BMI), apnea hypopnea index (AHI), oxygen saturation and desaturation index (ODI), Epworth sleepiness score (ESS), arousal parameter, and sleep patterns.
Results
The mean age was 60.2 years, 25 patients were male, 1 patient was female. Mean BMI was 29.0 kg/m2. The mean pre-implantation AHI of 33.9/h could be reduced to 9.1/h at 2 months post-implantation (p < 0.001). The amount of time spent in N1-sleep could be reduced from 23.2% at baseline to 16.0% at month 3 post-implantation. The amount of time spent in N2- and N3-sleep did not change during the observation period. A significant increase of the amount of REM sleep at month 2 (15.7%) compared to baseline (9.5%; p = 0.010) could be observed. A reduction of the number of arousals and the arousal index could be observed.
Conclusion
In conclusion, significant changes in sleep architecture of patients with OSA and sufficient treatment with UAS could be observed. A reduction of the amount of time spent in N1-sleep could be caused by treatment with UAS and the rebound of REM sleep, observed for the first time in a study on UAS, is also a potential marker of the efficacy of UAS on sleep architecture.
Trial registration
NCT02293746.
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No funding was received for this research.
Conflict of interest
Benedikt Hofauer, Markus Wirth, and Clemens Heiser received research support from Inspire Medical Systems. The article submitted is related to this relationship. Pierre Philip has a relationship with UCB, Sanofi, Takeda, Bastide, and Vital-Aire as a consultant. The article submitted is not related to this relationship. Andreas Knopf received research support from Optima Pharmazeutische GmbH. The article submitted is not related to this relationship. The trial was registered as NCT02293746 (Inspire Upper Airway Stimulation System German Post-Market Study) on clinicaltrial.gov as a sub-investigation of the German Post-Market Study.
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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.
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Informed consent was obtained from all individual participants included in the study.
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Hofauer, B., Philip, P., Wirth, M. et al. Effects of upper-airway stimulation on sleep architecture in patients with obstructive sleep apnea. Sleep Breath 21, 901–908 (2017). https://doi.org/10.1007/s11325-017-1519-0
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DOI: https://doi.org/10.1007/s11325-017-1519-0