Development of a standardized evaluation of endobuccal adverse events induced by repeated tongue protrusion with both a dedicated questionnaire and an endobuccal examination.

INTRODUCTION: A new approach to treat obstructive sleep apnea (OSA) is upper airway stimulation therapy (UAS). Electrical pulses applied to the hypoglossal nerve induce tongue protrusion, increase airway patency and decrease the frequency of apneic and hypopneic events. Thus, the main objective of this study was to design a standardized evaluation of endobuccal adverse events induced by repeated tongue protrusion with both a dedicated questionnaire and an endobuccal examination. METHOD: This study has designed the Tongue Adverse Event and Satisfaction Questionnaire (TAESQ) and an endobuccal examinations divided into an endobuccal lesion examination (ELE) and an endobuccal risk factor examination (ERFE). Evaluations were conducted at month 6 post-implantation. RESULTS: The study population after implantation of UAS device consisted of ten Caucasian males with a mean age of 51.9 ± 11.8 years, and a mean BMI of 28.6 ± 3.3. The AHI of the ten participants ranged from 46.7 ± 12.2/h at baseline to 14.5 ± 8.9/h with the Inspire therapy at the 6-month follow-up. The TAESQ revealed pain (30%), followed by less tongue sensitivity (20%) and tongue weakness (10%). The ELE did not reveal any lesions. The ERFE revealed that some participants had tissue and dental risk factors but not associated to more adverse events. CONCLUSION: The TAESQ, ELE and ERFE have been designed and studied on a small number of participants. These evaluations could systematically be included in the care pathway of patients treated by UAS to better investigate tongue discomfort and tongue lesion for patients treated with this technology.

Hypoglossal nerve stimulation on sleep and level of alertness in OSA: A preliminary study.

OBJECTIVES: To quantify the effect of hypoglossal nerve stimulation (HNS), a novel therapy for patients with obstructive sleep apnea, on objective level of alertness (measured with Maintenance of Wakefulness Test [MWT] values) and nocturnal sleep architecture. METHODS: Ten male patients (mean age 52.0 ± 9.4 years; mean body mass index 28.8 ± 3.3 kg/m2) noncompliant to continuous positive airway pressure received HNS (Inspire therapy) and were prospectively evaluated at baseline and 6 months after HNS therapy. Polysomnographic parameters (sleep breathing and sleep architecture) and objective level of alertness (MWT) were measured. RESULTS: The mean preimplantation apnea-hypopnea index of 46.7/h ± 12.2/h was reduced to 14.5/h ± 8.9/h at 6 months postimplantation (p < 0.001). The mean MWT latency improved from 25.0 ± 12.8 minutes at baseline to 36.8 ± 7.0 minutes after 6 months of treatment (p = 0.004). A reduction of N1% (11.8 ± 10.6 vs 4.2 ± 1.9, p = 0.04) was observed. The reduction in the duration of wake after sleep onset (WASO) was 71.4 ± 32.4 minutes vs 53.4 ± 13.5 minutes (p = 0.06) but was not significant. MWT latencies at 6 months were negatively correlated with the intensity of stimulation (r = -0.63, p = 0.05). Intensity of stimulation was positively correlated with WASO (r = 0.76, p = 0.01). CONCLUSION: HNS improved the objective level of alertness and changed nocturnal sleep architecture. The level of neural stimulation determines the amount of nocturnal WASO and the level of objective level of alertness.

[Implantable nerve stimulation for obstructive sleep apnea hypopnea syndrome]. / Traitement du syndrome d'apnées et hypopnées obstructives du sommeil par stimulation nerveuse implantable.

Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common disorder that has been identified as a contributor to cardiovascular disease making it a major public health problem. Continuous positive airway pressure is the standard treatment but compliance is suboptimal. Mandibular advancement devices and surgery have limited indications, inconstant efficiency and potential irreversible side effects. Stimulation of the hypoglossal nerve, that innervates the genioglossus, a protrusor muscle of the tongue, is now a new treatment option for moderate and severe cases of OSAHS. Two types of stimulation are currently available: stimulation synchronous with inspiration and continuous stimulation. The indication of each type of stimulation and long-term effects still need to be assessed but the implantable nerve stimulation is a promising treatment for patients without a therapy solution so far.