Abstract
Objectives:
Determine safety and effectiveness of targeted hypoglossal neurostimulation sleep therapy system for obstructive sleep apnea (OSA). Titration with multi-contact electrode and multi-channel pulse generator (IPG) allows stimulation of multiple areas of the proximal hypoglossal nerve permitting identification of optimal tongue position in each patient.
Methods:
A total of 105 adults were screened in this prospective, multicenter, single-arm study. Inclusion criteria were continuous positive airway pressure (CPAP) failure/intolerance, apnea hypopnea index (AHI) > 20, and body mass index (BMI) > 37. 56 patients meeting inclusion/exclusion criteria were surgically implanted with the unilateral hypoglossal nerve stimulator electrode and IPG (aura6000TM System, Imthera Medical, San Diego). Patients were evaluated at 1, 3, 6, and 12 months. Outcomes included AHI, oxygen desaturation index (ODI), Epworth Sleepiness Scale (ESS), Sleep Apnea Quality of Life Index, and EQ-5D quality of life questionnaire.
Results:
Postsurgical transient tongue paresis was observed in 5 out of 56 patients (8.9%); all resolved spontaneously. Four patients withdrew, leaving 52 subjects to complete the study by September 2014. All were male, with mean age of 54.8 ± 10.6 years, and mean BMI of 30.4 ± 3.6. Preliminary data at month 3 showed significant decrease in AHI by 43.7% from 50.5 ± 18.4 to 26.7 ± 19.8 (P < .001) and significant improvement in ESS from 12.4 ± 4.0 to 9.1 ± 4.5 (P < .001).
Conclusions:
Surgical implantation of targeted hypoglossal neurostimulation sleep therapy system appears to be a safe and practical treatment option for OSA. Preliminary data shows significant improvement in objective and subjective outcomes. Final safety and effectiveness will be determined.
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