Treating Obstructive Sleep Apnea with Hypoglossal Nerve Stimulation

Eastwood, Peter R.; Barnes, Maree; Walsh, Jennifer H.; Maddison, Kathleen J.; Hee, Geoffrey; Schwartz, Alan R.; Smith, Philip L.; Malhotra, Atul; McEvoy, R. Doug; Wheatley, John R.; O’Donoghue, Fergal J; Rochford, Peter D.; Churchward, Thomas J; Campbell, Matthew C.; Palme, Carsten E.; Robinson, Simon; Goding, George S.; Eckert, Danny J.; Jordan, Amy S.; Catcheside, Peter; Tyler, Louise; Antic, Nick A.; Worsnop, Christopher; Kezirian, Eric J.; Hillman, David R.

doi:10.5665/sleep.1380

Cited by 235 publications

(234 citation statements)

References 30 publications

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“…Thirty patients with obstructive sleep apnea who were implanted with a novel HGNS system (Apnex Medical, Inc., St. Paul, MN) were recruited (23). Written informed consent was obtained.…”

Section: Methods Patient Populationmentioning

confidence: 99%

Acute Upper Airway Responses to Hypoglossal Nerve Stimulation during Sleep in Obstructive Sleep Apnea

Schwartz

Barnes

Hillman

et al. 2012

Am J Respir Crit Care Med

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Rationale: Hypoglossal nerve stimulation (HGNS) recruits lingual muscles, reduces pharyngeal collapsibility, and treats sleep apnea. Objectives: We hypothesized that graded increases in HGNS relieve pharyngeal obstruction progressively during sleep. Methods: Responses were examined in 30 patients with sleep apnea who were implanted with an HGNS system. Current (milliampere) was increased stepwise during non-REM sleep. Frequency and pulse width were fixed. At each current level, stimulation was applied on alternating breaths, and responses in maximal inspiratory airflow (V I max) and inspiratory airflow limitation (IFL) were assessed. Pharyngeal responses to HGNS were characterized by the current levels at which V I max first increased and peaked (flow capture and peak flow thresholds), and by the V I max increase from flow capture to peak (DV I max). Measurements and Main Results: HGNS produced linear increases in V I max from unstimulated levels at flow capture to peak flow thresholds (215 6 21 to 509 6 37 ml/s; mean 6 SE; P , 0.001) with increasing current from 1.05 6 0.09 to 1.46 6 0.11 mA. V I max increased in all patients and IFL was abolished in 57% of patients (non-IFL subgroup). In the non-IFL compared with IFL subgroup, the flow response slope was greater (1241 6 199 vs. 674 6 166 ml/s/mA; P , 0.05) and the stimulation amplitude at peak flow was lower (1.23 6 0.10 vs. 1.80 6 0.20 mA; P , 0.05) without differences in peak flow. Conclusions: HGNS produced marked dose-related increases in airflow without arousing patients from sleep. Increases in airflow were of sufficient magnitude to eliminate IFL in most patients and IFL and non-IFL subgroups achieved normal or near-normal levels of flow, suggesting potential HGNS efficacy across a broad range of sleep apnea severity.Keywords: obstructive sleep apnea; electrical hypoglossal nerve stimulation; pharynx; upper airway; titration Obstructive sleep apnea is characterized by recurrent episodes of upper airway obstruction during sleep (1). Airflow obstruction is thought to result from decreases in pharyngeal neuromuscular activity at sleep onset (2). These episodes lead to intermittent hypoxemia and recurrent arousals from sleep, accounting for the long-term neurocognitive (3, 4), metabolic (5), and cardiovascular (6) sequelae of this disorder. Nasal continuous positive airway pressure remains the mainstay of treatment for moderate to severe obstructive sleep apnea (7). Difficulties adhering to therapy can limit its effectiveness in the home setting (8, 9), and alternatives have been generally less effective in relieving upper airway obstruction during sleep (10-12).Hypoglossal nerve stimulation (HGNS) has been piloted as treatment for obstructive sleep apnea (13). Implantable HGNS systems have been developed to stimulate the hypoglossal nerve during inspiration, and recruit the lingual musculature, leading to decreases in pharyngeal collapsibility during sleep (14-17). Motor activity protrudes the tongue, and mitigates airflow obstruction during sleep (18,19)....

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“…Thirty patients with obstructive sleep apnea who were implanted with a novel HGNS system (Apnex Medical, Inc., St. Paul, MN) were recruited (23). Written informed consent was obtained.…”

Section: Methods Patient Populationmentioning

confidence: 99%

Acute Upper Airway Responses to Hypoglossal Nerve Stimulation during Sleep in Obstructive Sleep Apnea

Schwartz

Barnes

Hillman

et al. 2012

Am J Respir Crit Care Med

Self Cite

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“…After 3 month-long therapy, the Authors reported a decrease in mean AHI by 56% (from 43 to 19), with decreases in total and respiratory-related arousals (47% and 66%, respectively). Sleepiness, sleep quality and quality of life questionnaire scores also improved [62]. However, 71% of patients reported at least one adverse event including tongue abrasion.…”

Section: Osahs Treatmentmentioning

confidence: 94%

“…reported that apnea events and associated daytime symptoms reappeared after 1-week treatment withdrawal [133]. Similarly, Eastwood et al [62] recently carried out a multicenter study involving 21 moderate-to-severe OSAHS patients to test the efficiency of the HGNS® neurostimulator system (Roseville, MN, USA). After 3 month-long therapy, the Authors reported a decrease in mean AHI by 56% (from 43 to 19), with decreases in total and respiratory-related arousals (47% and 66%, respectively).…”

Section: Osahs Treatmentmentioning

confidence: 99%

“…Moreover, selective stimulation of both the lateral XII nerve branches and the medial nerve branch seems to increase maximum rate of airflow and mechanical stability [42,58,59]. Recent studies assessing efficacy of current commercial devices for electrical neurostimulation report significant improvement in AHI and quality of life measures [60][61][62].…”

Section: Osahs Treatmentmentioning

confidence: 99%

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Positive airway pressure and electrical stimulation methods for obstructive sleep apnea treatment: a patent review (2005 – 2014)

Álvarez

Gutiérrez‐Tobal

Campo

et al. 2015

Expert Opinion on Therapeutic Patents

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Introduction. Obstructive sleep apnea-hypopnea syndrome (OSAHS) is a major health problem with significant negative effects on the health and quality of life. Continuous positive airway pressure (CPAP) is currently the primary treatment option and it is considered the most effective therapy for OSAHS. Nevertheless, comfort issues due to improper fit to patient's changing needs and breathing gas leakage limit the patient's adherence to treatment.

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“…Some studies showed improvement of sleep parameters [98,104]; others failed to find any effects [105,106]. In a recent study, the authors have shown significant improvement of AHI from 43 to 19/ h with hypoglossal nerve stimulation, however it failed to resolve sleep apnea [107].…”

Section: Hypoglossus Nerve Stimulation and Muscle Trainingmentioning

confidence: 94%

Non-positive airway pressure therapy for obstructive sleep apnea

Jafari

Roux

2012

Curr Respir Care Rep

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Obstructive sleep apnea (OSA) is a common disorder associated with cardiovascular morbidity. Various methods are offered to improve symptoms of OSA and its outcome. Although positive airway pressure is the most effective treatment for OSA, its clinical effectiveness is limited by patients' compliance. Other suggested treatments for OSA focus on expanding upper airway and reducing its collapsibility. For example, mandibular advancement device (MAD) achieves this goal by mechanically protruding the mandible. Other available treatments including weight reduction, positional therapy, drugs, nasal dilators, and nasal expiratory pressure device are clearly inferior to CPAP.

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Treating Obstructive Sleep Apnea with Hypoglossal Nerve Stimulation

Abstract: NCT01186926. URL: http://clinicaltrials.gov/ct2/show/NCT01186926.

Cited by 235 publications

References 30 publications

Acute Upper Airway Responses to Hypoglossal Nerve Stimulation during Sleep in Obstructive Sleep Apnea

Acute Upper Airway Responses to Hypoglossal Nerve Stimulation during Sleep in Obstructive Sleep Apnea

Positive airway pressure and electrical stimulation methods for obstructive sleep apnea treatment: a patent review (2005 – 2014)

Non-positive airway pressure therapy for obstructive sleep apnea

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