Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study.

Continuous positive airway pressure (CPAP) is an effective but cumbersome treatment for obstructive sleep apnoea (OSA). Noncompliant patients need alternative therapies. We studied a tongue neurostimulation approach: targeted hypoglossal neurostimulation (THN) therapy with the aura6000™ System. A multi-contact electrode positioned around the main trunk of the twelfth nerve connected to an implanted pulse generator stimulates segments of the nerve, activating dilator muscles. The primary objective was to improve the polysomnographically determined apnoea/hypopnoea index (AHI) at 3 months, and maintain the improvement after 12 months of treatment. 13 out of 14 operated patients were successfully implanted. At 12 months, the AHI decreased from 45±18 to 21±17, a 53% reduction (p<0.001). The 4% oxygen desaturation index fell from 29±20 to 15±16 and the arousal index from 37±13 to 25±14, both p<0.001. The Epworth sleepiness scale decreased from 11±7 to 8±4 (p=0.09). THN was neither painful nor awakened patients, who all complied with therapy. There were two transient tongue paresis. The present study represents the longest study of any hypoglossal neurostimulation reported to date. We conclude that THN is safe and effective to treat OSA in patients not compliant with CPAP.

Effect of changes in periodic limb movements under cpap on adherence and long term compliance in obstructive sleep apnea.

Purpose of the study Periodic leg movements (PLMs) are found in 30% of patients suffering from OSA. Under CPAP, we observed that PLMs can increase, decrease, or remain unchanged. The predictors of these changes are not well established. Objective To determine the predictors of PLMs change under CPAP and its impact on long-term adherence. Materials and method The patients were referred to the sleep laboratory for snoring or sleepiness. A single PSG night has been performed before and after CPAP treatment. Data on medication used, comorbidities and ferritin level were collected. Results A total of 160 patients were recruited with a severe OSA. About 32.5% (52/160) patients had emerging PLM i.e. that appeared after the disappearance of respiratory events. By comparing patients with emerging-PLMs to others, we found that only the blood ferritin level was significantly different between groups. Moreover, after one-year follow-up, a significant difference in adherence and long-term compliance was observed between patients without PLM at both screening and CPAP polysomnographies or emerging PLM at the second study (56%) vs. patients with baseline PLM, whether PLM remained stable or decreased under CPAP treatment (75%) (p-value 0.028). Serum ferritin and presence of diabetes mellitus predicted the evolution of PLM observed. Patients with low ferritin levels demonstrated an increase of PLM after initiation of nasal CPAP treatment. Conclusion The emergence of PLM negatively impacts long-term adherence to nasal CPAP treatment in OSA. Blood ferritin level is a predictor of the evolution of PLM under CPAP therapy.

Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: Six-month results.

OBJECTIVES/HYPOTHESIS: This feasibility study was designed to show the preliminary safety and efficacy of targeted hypoglossal neurostimulation (THN), and to identify baseline predictors of successful therapy. STUDY DESIGN: Open-label, prospective, multicenter, single-arm cohort study, conducted at seven centers in the U.S.A. and Europe. METHODS: Forty-six participants with moderate to severe obstructive sleep apnea (OSA), failing or intolerant of continuous positive airway pressure, were implanted. Primary (Apnea-Hypopnea Index [AHI], Oxygen Desaturation Index [ODI]) and secondary (Arousal Index, Epworth Sleepiness Scale Index, Sleep Apnea Quality of Life Index) outcomes were measured at baseline and compared at 6 months. Data were analyzed to identify participant characteristics that would predict success with therapy. RESULTS: Sixty-seven adverse events (AEs) were observed among 36 participants; most of the AEs were related to the implant procedure and resolved without sequelae; one device replacement was necessary. Forty-three participants showed significant (P < .01) decreases in both AHI and ODI at 6 months; 35% (15 of 43) met criteria for AHI responders and 40% (17 of 43) for ODI responders. Significant improvement was observed in all the secondary endpoints. Predictors-of-success selection criteria were identified as baseline AHI < 65/hr, baseline apnea index ≤ 30, baseline body mass index < 35, and <15 events/hr of SpO2 decrease > 10%. Seven participants met these criteria; 86% (6 of 7) were AHI responders and 86% (6 of 7) were ODI responders, indicating that THN therapy can be efficacious in a carefully selected population of OSA patients. CONCLUSIONS: This feasibility study suggests that THN therapy is likely to be safe and effective in selected patients. LEVEL OF EVIDENCE: 2b Laryngoscope, 126:2618-2623, 2016.

Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea.

Obstructive sleep apnea (OSA) is a very frequent affliction that affects about 1-5% of the adult population in its severe form. Continuous positive airway pressure (CPAP) is the most commonly used treatment and is highly effective, but its use is limited by low long-term adherence rates and overall poor acceptance among the patients. Therefore, there is a need for developing alternative approaches to OSA treatment, including a more 'natural' concept of maintaining an open airway through neuromodulation. Here we review the concept, scientific rationale, and technical details of hypoglossal nerve stimulation. We also review results of published clinical studies with several hypoglossal stimulation devices that are being investigated today. Hypoglossal nerve stimulation appears to be a very promising treatment for patients with moderate-to-severe OSA. If its efficacy is confirmed, it will probably be complementary with CPAP therapy and initially aimed at patients unable or unwilling to use CPAP. Once it becomes a standard therapy, its advantages might prove sufficient to challenge CPAP as the first-line therapy.