G47.31
Conditions
Interventions
Group 1: The aim of this clinical investigation is to determine whether the electrostimulation of the iSLN is able to partially or completely relieve/prevent OSA-related upper airway obstruction.
The
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 years • Male subjects with a previous clinical diagnosis of obstructive sleep apnoea and who, independently from their enrolment in this clinical investigation, were scheduled for a DISE session • BMI = 35 • High motivation with realistic expectations regarding the participation in this study • Anatomic, physiological, and mental conditions compatible with the participation in this study • Signed and dated informed consent before the start of any study-specific procedure
Exclusion criteria
Exclusion criteria: • Lack of compliance with any inclusion criteria • cognitive disabilities • Use of recreational drugs • Heavy smoker in past 2 years • Wearing an implantable active device (e.g. heart pacemaker) • Other clinical diseases that might result in sleep alterations: e.g. COPD, other pulmonary diseases, heart failure, other cardiac diseases, Cheyne-Stokes respiration, thyroid disease, psychiatric disorders, alcoholism or drug abuse, use of sleep inducing medications, epilepsy, BMI > 35, hypoventilation syndrome, insomnia, narcolepsy, night terrors, parasomnias, nocturia, rhythmic movement disorder (RMD), periodic limb movement disorder (PLMS), or other neurological disorders • Infection of the upper airway or nasal congestion • Previous history of dysphagia or other swallowing disorders, laryngospasm, cancer of the head or neck • Tracheostomy, UPPP, or other surgical intervention for apnoea with the exclusion of nose-related surgeries, tonsillectomies and/or adenoidectomies • Concomitant use of propranolol, sulpiride, carbamazepine, dextromethorphan, sleep aids, or other current medications known to interfere with sleep, swallow, or breathing • Nose, mouth or head injuries that may constitute a contraindication for nasopharyngeal intubation • Bleeding disorders, clotting problems, use of anticoagulants • Known allergies or intolerance to the material and sedation substances used for this study • Current participation in other drugs and/or medical device studies that can affect the results of the present trial • Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of whether the obstruction is partially or completely relieved during the direct stimulation of the iSLN according to the VOTE classification; video endoscope; stimulation report. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Assessment of the underlying mechanism of action of the iSLN stimulation; M. genioglossus EMG results • Functional assessment of the correct position of the iSLN stimulation electrode regarding activation of the thyroarytenoid (TA) muscle; Video endoscope; onset latency of stimulation • Analysis of the effects of iSLN electrostimulation on nasal airflow, chest movement during respiration, breathing and snore sounds and on physiological parameters; routine DISE results • Effects of unilateral iSLN stimulation with surface electrodes (if no effective parameters could be found using hook wire stimulation); endoscope; stimulation report; Videoendoskopie; Stimulationsbericht. | — |
Countries
Austria, Germany
Contacts
Public ContactPia Plattner
MED-EL Elektromedizinische Geräte GmbH
Outcome results
None listed