Development of a Clinical Pathway and Technical Aspects of Upper Airway Stimulation Therapy for Obstructive Sleep Apnea

Abstract

Obstructive sleep apnea (OSA) is a common disease with high morbidity and related mortality. Narrowing and collapse of the pharyngeal airway during sleep characterize the disease, resulting in a decrease (hypopnea) or a complete cessation (apnea) of oronasal airflow. Upper airway stimulation (UAS), using electrical neurostimulation of the hypoglossal nerve (n. XII) synchronized with ventilation, is a novel, evolving treatment option. UAS was found to be an effective treatment in CPAP-intolerant patients. The treatment success is partly due to the strict selection of the patients, based on previous findings. Furthermore, post-operative follow-up is needed in order to maintain or improve treatment outcome. Therefore, a clinical pathway, which provides structure and standardization, is crucial. In this paper, the aim is to discuss the technical aspects of UAS therapy and to describe a clinical pathway to organize the care process of UAS for OSA in a structured and standardized way.

Kinesthetic stimulation for obstructive sleep apnea syndrome: An “on-off” proof of concept trial

“…We believe that the range of improvement shown in this proof of concept study will be increased both by refining the stimulation technique itself and also by a prospective identification of responder’s profile as it has been done for hypoglossal stimulation 9,19 . Indeed, in this study, we retrospectively labelled patients as ‘responders’ when they presented a statistically significant decrease in terms of event duration for either apnea or hypopnea events.…”

Kinesthetic stimulation for obstructive sleep apnea syndrome: an “on-off” proof of concept trial

“…The overall response to kinesthetic stimulation was significant but clinical relevance of the size effect can be discussed. We believe that the range of improvement shown in this proof of concept study will be increased both by refining the stimulation technique itself and also by a prospective identification of responder's profile as it has been done for hypoglossal stimulation 9,19 . Indeed, in this study, we retrospectively labelled patients as 'responders' when they presented a statistically significant decrease in terms of event duration for either apnea or hypopnea events.…”

Drug‐Induced Sleep Endoscopy Upper Airway Collapse Patterns and Maxillomandibular Advancement

“…A complete concentric collapse at the level of the palate (CCCp), as observed during DISE, has been a reported predictor for decreased success rate of some specific non‐CPAP treatment options such as UA stimulation, UA surgery, and MAD . Specifically, surgical treatment with UA stimulation, using electrical neurostimulation of the hypoglossal nerve synchronized with ventilation, fails to reduce OSA severity in patients with CCCp . Consequently, according to the Food and Drug Administration approval statement, CCCp became a formal exclusion criterion for UA stimulation therapy …”

“…[15][16][17][18] Specifically, surgical treatment with UA stimulation, using electrical neurostimulation of the hypoglossal nerve synchronized with ventilation, fails to reduce OSA severity in patients with CCCp. 15,16,19 Consequently, according to the Food and Drug Administration approval statement, CCCp became a formal exclusion criterion for UA stimulation therapy. 15,16 The aim of the present prospective study was to evaluate the effect of UA collapse patterns as observed during DISE on MMA surgery outcome, with particular attention to the effect of a preexisting CCCp DISE phenotype.…”