ultrasonography
Diagnostic TestAssessment of tongue morphology and posterior airway space using ultrasonography (AmCAD-UO, CE mark NB1639)
NCT Number: NCT06154577
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 alternative treatment options, such as mandibular advancement devices or positional therapy. The posterior upper airway space dimensions are crucial in managing patients with HNS in the patient selection process and therapy control. The lateral collapse of the upper airway is of crucial importance. Lateral collapse at the palatal level and of the oropharyngeal walls is a well-established negative predictive factor for therapeutic success. Patients with complete concentric collapse at the palatal level (pCCC) in drug-induced sedation endoscopy (DISE) must be excluded from the implantation of HNS, which is cumbersome and invasive. Endoscopy has the inherent limitation that only one level can be observed at a given time, and assessment is possibly hampered by phlegm.
During activation and titration of HNS, tongue protrusion is observed in the awake patient. However, this method does not allow for assessing the opening of the retroglossal (RG) and retropalatal (RP) airway space, which is the ultimate therapeutic goal. Insufficient opening of the airway is the reason for non-responders with HNS. Insufficient upper airway opening can be either at the retropalatal or retroglossal level. The study aims to identify insufficient airway openings better using sub-mental ultrasonography. Sub-mental standardized and orientated ultrasonography offers a quantitative, reproducible way of assessing transverse upper airway dimensions and anatomic features of the upper airway in a rapid and non-invasive manner. In addition, anatomic characteristics of the airway's adjacent tissue, such as the size and shape of the tongue, may also have an impact on the effectiveness of HNS. Tongue morphology and posterior airway space assessment could be used in preoperative evaluation and during therapeutic titration of HNS. The clinical routine could be included tongue morphology and posterior airway space assessment without additional patient risks. However, the clinical value of assessing posterior airway space and tongue morphology in patients with HNS is yet unknown.
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Notify Me18 year and older
All sexes
Observational
Kantonsspital Baselland, Liestal, Basel-Landschaft, Switzerland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Assessment of tongue morphology and posterior airway space using ultrasonography (AmCAD-UO, CE mark NB1639)
Time frame: Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination
Success is defined as apnea-hypopnea index in the most recent sleep testing ≤ 20/h and 50% reduction from baseline
Time frame: Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination
AHI reduction is defined as apnea-hypopnea index in the most recent sleep compared to the baseline value before HNS implantation
Time frame: through study completion, from 15.05.2023 to 14.05.2024
Visual assessment is performed both by DISE and wake transnasal endoscopy. Tongue morphology and posterior airway space is analyzed using ultrasonography
Time frame: through study completion, from 15.05.2023 to 14.05.2024
Changes to therapeutic HNS settings during study visit
Time frame: through study completion, from 15.05.2023 to 14.05.2024
Rated on a visual analog scale (VAS) from 0 to 10 (0 meaning no discomfort; 10 meaning very uncomfortable
Time frame: through study completion, from 15.05.2023 to 14.05.2024
Rating by the physician if the additional information gained from tongue morphology and posterior airway space imaging at functional stimulation threshold is a valuable adjunct to the oral observation of tongue protrusion rated on a VAS
Time frame: through study completion, from 15.05.2023 to 14.05.2024
Pharyngeal dimensions measured using ultrasonography
Cantonal Hosptal, Baselland
Other
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