G47.31
Conditions
Interventions
Group 1: This clinical investigation consists of a Screening Visit and a Test Session, both conducted on the same day. The total participation time per patient is approximately 3 hours.
Study Visits:
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 OSA 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 clinical investigation • Anatomic, physiological, and mental conditions compatible with the participation in this clinical investigation • Signed and dated informed consent before the start of the iSLN stimulation.
Exclusion criteria
Exclusion criteria: • Lack of compliance with any inclusion criteria • Cognitive disabilities • Alcoholism or drug abuse • Use of sleep-inducing medications • 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, epilepsy, BMI >35, hypoventilation syndrome, insomnia, narcolepsy, night terrors, parasomnias, nocturia, rhythmic movement disorder (RMD), periodic limb movement disorder (PLMD), 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 apnea with the exclusion of nose-related surgeries, tonsillectomies and/or adenoidectomies • Current use of medications known to interfere with sleep, swallow, or breathing, e.g., propranolol, sulpiride, carbamazepine, dextromethorphan, or sleep aids • 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 clinical investigation • Current participation in other drugs and/or medical device studies that can affect the results of the present clinical investigation • 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 clinical investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "Change in the collapse pattern according to the VOTE Index" i.e. : There is a significant improvement in upper airway obstruction in response to iSLN stimulation as measured by the VOTE-index when comparing pre-stimulation to intra-stimulation conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this clinical investigation will be assessed merely descriptively, without preset hypotheses. They do not determine the success or failure of this clinical investigation, which is solely linked to the verification of the primary hypothesis. The descriptive assessment of the secondary objectives in the first interim analysis may contribute to the implementation of adaptive features such as the inclusion of an additional primary objective or the removal of unsuitable outcome measures to the next phase 1 of this clinical investigation. | — |
Countries
Germany
Contacts
Public ContactJoachim T. Maurer
Medizinische Fakultät Mannheim der Universität Heidelberg
Outcome results
None listed