Therapeutic electrical stimulation of the hypoglossal nerve in obstructive sleep apnea.

BACKGROUND: Hypoglossal nerve stimulation has been demonstrated to relieve upper airway obstruction acutely, but its effect on obstructive sleep apnea is not known. OBJECTIVE: To determine the response in obstructive sleep apnea to electrical stimulation of the hypoglossal nerve. METHODS: Eight patients with obstructive sleep apnea were implanted with a device that stimulated the hypoglossal nerve unilaterally during inspiration. Sleep and breathing patterns were examined at baseline before implantation and after implantation at 1, 3, and 6 months and last follow-up. RESULTS: Unilateral hypoglossal nerve stimulation decreased the severity of obstructive sleep apnea throughout the entire study period. Specifically, stimulation significantly reduced the mean apnea-hypopnea indices in non-rapid eye movement (mean +/- SD episodes per hour, 52.0 +/- 20.4 for baseline nights and 22.6 +/- 12.1 for stimulation nights; P<.001) and rapid eye movement (48.2 +/- 30.5 and 16.6 +/- 17.1, respectively; P<.001) sleep and reduced the severity of oxyhemoglobin desaturations. With improvement in sleep apnea, a trend toward deeper stages of non-rapid eye movement sleep was observed. Moreover, all patients tolerated long-term stimulation at night and did not experience any adverse effects from stimulation. Even after completing the study protocol, the 3 patients who remained free from stimulator malfunction continued to use this device as primary treatment. CONCLUSION: The findings demonstrate the feasibility and therapeutic potential for hypoglossal nerve stimulation in obstructive sleep apnea.

Long-term monitoring of respiration with a mediastinal pressure sensor in dogs.

The ability of an implanted mediastinal pressure sensor to produce a stable respiratory signal that could be used to trigger stimulation of upper airway muscles was examined. In 6 dogs, a pressure sensor was secured to the manubrium (4 by wires and 2 by transmanubrial placement). In 6 other dogs, the pressure sensor was placed in the upper anterior mediastinum. The animals were monitored for a minimum of 8 weeks (2 transmanubrial sensors for 12 months). Sensors that were able to maintain a midline position, high in the mediastinum, had the best signals. A caudal sensor position or abutment against an intrathoracic structure caused signal inversion (unusable signals). Transmanubrial placement resulted in a stable signal for 1 year. We conclude that long-term monitoring of respiration with a mediastinal pressure sensor can be successfully performed in dogs, providing an adequate signal for nerve-muscle stimulation. Separation from cardiovascular structures improves signal quality.

Chronic intermittent stimulation of the thyroarytenoid muscle maintains dynamic control of glottal adduction.

Patients with laryngeal motor control disorders need improved dynamic glottal closure for speech and swallowing. To evaluate the functional outcome of intermittent chronic thyroarytenoid muscle stimulation in an animal model, 6 canines were implanted with bilateral Medtronic Xtrel systems containing Peterson-type electrodes in the inferior and superior portions of the thyroarytenoid muscle. Stimulation was on one side only at 60 Hz, for 5 s on and 5 s off, over 8 h, 5 days per week, up to 8 months. Monthly videorecordings were done under anesthesia to measure the voltage threshold for detectable movement on each side, and vocal fold displacement and velocity during maximal stimulation of each side. Movement thresholds were lower in the inferior portion of the thyroarytenoid muscle (P

Relief of upper airway obstruction with hypoglossal nerve stimulation in the canine.

Hypoglossal nerve stimulation was investigated as a method to relieve an induced upper airway obstruction. Six dogs were implanted with a cuff electrode applied to each hypoglossal nerve and a pulse generator. After 4 weeks, the hypoglossal nerve was stimulated (50% duty cycle) for up to 8 weeks. At 12 weeks a double tracheotomy was placed, with a negative pressure intermittently applied to the upper limb, simulating inspiratory airway pressure. Unilateral hypoglossal nerve stimulation improved peak upper airway flow from an average of 0.1 L/s to 1.6 L/s (P = 0.0001). Seventy-seven percent of the maximum possible flow (explanted tracheotomy tube) was obtained with unilateral stimulation. Histopathological evaluation revealed no nerve damage secondary to chronic stimulation. This study provides support for clinical trials of hypoglossal stimulation for obstructive sleep apnea.

Electrical stimulation of the lingual musculature in obstructive sleep apnea.

The influence of lingual muscle activity on airflow dynamics in the upper airway was examined in nine patients with obstructive sleep apnea. Muscles that retract the tongue (hyoglossus and styloglossus) and protrude the tongue (genioglossus) were selectively stimulated electrically during sleep with fine wire electrodes placed intramuscularly transorally. We confirmed that stimulation with 50 Hz and 40-microseconds pulse duration did not elicit changes in electroencephalographic patterns or heart rate or alter airflow after the stimulation burst had ceased. The highest stimulus intensity that did not arouse patients from sleep was then utilized to examine the effect of lingual muscle recruitment on airflow dynamics during steady-state periods of inspiratory airflow limitation. When applying a stimulus burst during single inspirations, maximal inspiratory airflow decreased by 239 +/- 177 ml/s (P < 0.05) during retractor stimulation, whereas maximal inspiratory airflow increased by 217 +/- 93 ml/s during protrusor stimulation (P < 0.001) compared with breaths immediately before and after the stimulated breath. When consecutive inspirations were stimulated repeatedly, protrusor stimulation decreased the frequency of obstructive breathing episodes in four patients breathing at 3.9 +/- 3.4 (SD) cmH2O nasal pressure. The findings suggest that stimulation of the lingual muscles can increase or decrease airflow depending on the specific muscles stimulated without arousing patients from sleep.