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Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy

Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06154577
Enrollment
65
Registered
2023-12-04
Start date
2023-05-15
Completion date
2024-05-29
Last updated
2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Sleep-Disordered Breathing

Keywords

hypoglossal nerve stimulation, ultrasonography

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 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.

Interventions

DIAGNOSTIC_TESTUltrasonography

Assessment of tongue morphology and posterior airway space using ultrasonography (AmCAD-UO, CE mark NB1639)

Sponsors

Insel Gruppe AG, University Hospital Bern
CollaboratorOTHER
Cantonal Hosptal, Baselland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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 criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Prediction of therapeutic success with hypoglossal nerve stimulationMost recent sleep testing before examination after HNS implantation, a maximum of 6 months before examinationSuccess is defined as apnea-hypopnea index in the most recent sleep testing ≤ 20/h and 50% reduction from baseline

Secondary

MeasureTime frameDescription
Prediction of AHI reduction, defined as the difference between pre- and postoperative AHI, with HNS based on tongue morphology and posterior airway space.Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examinationAHI reduction is defined as apnea-hypopnea index in the most recent sleep compared to the baseline value before HNS implantation
Comparison of pharyngeal dimensions between visual assessment and tongue morphology and posterior airway spacethrough study completion, from 15.05.2023 to 14.05.2024Visual assessment is performed both by DISE and wake transnasal endoscopy. Tongue morphology and posterior airway space is analyzed using ultrasonography
Therapeutical guidance using tongue morphology and posterior airway space to identify the obstructing upper airway segment compared to wake fiberoptic endoscopy during HGS in non-responders.through study completion, from 15.05.2023 to 14.05.2024Changes to therapeutic HNS settings during study visit
Information gain through from tongue morphology and posterior airway space imagingthrough study completion, from 15.05.2023 to 14.05.2024Rating 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
Comparison of pharyngeal dimensions of healthy and patients with OSA and HNSthrough study completion, from 15.05.2023 to 14.05.2024Pharyngeal dimensions measured using ultrasonography
Patient comfort rated by the patients for wake transnasal endoscopy and sub-mental ultrasonographythrough study completion, from 15.05.2023 to 14.05.2024Rated on a visual analog scale (VAS) from 0 to 10 (0 meaning no discomfort; 10 meaning very uncomfortable

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026