NCT03844295

Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve

Upper AIRway Implanted Nerve STIMulation Therapy: A Breakthrough in Obstructive Sleep Apnea Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Continuous positive airway pressure (CPAP) is the gold standard to normalize breathing during sleep in patients with obstructive sleep apnea syndrom (OSA). Many patients will not tolerate or will not accept CPAP. Implanted nerve stimulation is a novel therapy for OSA patients that restores the upper airway potency using unilateral XII nerve electric stimulation. The principal objective of this study is short-term efficacy of a new treatment for OSA on blood pressure variability during sleep.

Detailed description

Obstructive sleep apnea (OSA) syndrome had become over the last decade a serious health concern due to its high prevalence which raise 10% of the general population. It is characterized by recurrent episodes of airflow obstruction in the upper airway (UA) consequence of passive collapse of the UA, particularly at the tongue level. These collapses induce recurrent asphyxia that results in oxygen desaturations with persistant and crescendo respiratory efforts inducing arousals from sleep. Indeed, despite its large efficacy some of the patients will never accept continuous positive airway pressure treatment or will not tolerate. To this extent, alternative treatement has been developed: implanted hypoglossal stimulation. This treatment has been developed by Inspire Medical Device. The Inspire® system is intended to prevent base-of-tongue obstruction as well as specific soft palate obstructions by stimulating the hypoglossal nerve synchronous with respiration. A selection processus will be applied in order to identify the patients that will be good responders to the hypoglossal stimulation. The main criterion of selection is based on Drug Induced Sleep Endoscopy(DISE) that will be performed by a trained endoscopist dedicated to this study. This sleep endoscopy allows to visualize during induced sleep the shape of the UA and the type of collapsus. Indeed an antero-posterior collapsus is related to a good response to hypoglossal nerve stimulation while complete concentric obstruction at velopharyngeal is a predictor of poor response. In this pilot study, the investigators evaluate as a primary outcome the delta range of blood pressure during sleep but also other cardiovascular indexes targeting blood pressure and heart rate variability as secondary outcomes.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DEVICE	Activated Inspire® Upper Airway Stimulation System	At first, INSPIRE® device will be active a month
DEVICE	Inactivated Inspire® Upper Airway Stimulation System	After 15 days "wash-out" INSPIRE® device will be inactivated for a second period of one month.

Timeline

• Start date: 2019-03-21
• Primary completion: 2021-12-22
• Completion: 2023-10-10
• First posted: 2019-02-18
• Last updated: 2024-07-26

Locations

1 site across 1 country: France