Status:
COMPLETED
Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy
Lead Sponsor:
Cantonal Hosptal, Baselland
Collaborating Sponsors:
Insel Gruppe AG, University Hospital Bern
Conditions:
Obstructive Sleep Apnea
Sleep-Disordered Breathing
Eligibility:
All Genders
18+ years
Brief Summary
Hypoglossal nerve stimulation (HNS) plays an increasingly important role in managing patients with obstructive sleep apnea (OSA) who do not tolerate CPAP therapy and are not eligible for other alterna...
Eligibility Criteria
Inclusion
- Patients older than 18 year
- patients with a hypoglossal nerve implantation
- control group: 15 subjects without OSA (AHI\<10/h)
- written informed consent
- sufficient knowledge of German or French to understand informed consent
Exclusion
- Patients younger than 18 years
- unwillingness to give informed consent
- incapable of performing Müller's maneuver
- history of head and neck surgery other than HNS, tonsillectomy, and maxillomandibular advancement
- diagnosis of congestive heart failure or chronic pulmonary disease
- diagnosis of co-morbid sleep disorders, including central sleep apnea
- pregnancy
Key Trial Info
Start Date :
May 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 29 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06154577
Start Date
May 15 2023
End Date
May 29 2024
Last Update
June 5 2024
Active Locations (2)
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1
Kantonsspital Baselland
Liestal, Basel-Landschaft, Switzerland, 4410
2
University Hospital Bern, Inselspital
Bern, Switzerland, 3010