Clinical trial NCT06154577: Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy
Official title: Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Sleep-Disordered Breathing
Keywords: hypoglossal nerve stimulation
ultrasonography
Lead sponsor: Cantonal Hosptal, Baselland
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2023-12-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 39 obstructive sleep apnea patients with hypoglossal nerve stimulation and 15 subjects in the control group

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prediction of therapeutic success with hypoglossal nerve stimulation
timeFrame: Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination
Secondary outcomes:
measure: Prediction of AHI reduction, defined as the difference between pre- and postoperative AHI, with HNS based on tongue morphology and posterior airway space.
timeFrame: Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination
measure: Comparison of pharyngeal dimensions between visual assessment and tongue morphology and posterior airway space
timeFrame: through study completion, from 15.05.2023 to 14.05.2024
measure: 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.
timeFrame: through study completion, from 15.05.2023 to 14.05.2024
measure: Patient comfort rated by the patients for wake transnasal endoscopy and sub-mental ultrasonography
timeFrame: through study completion, from 15.05.2023 to 14.05.2024
measure: Information gain through from tongue morphology and posterior airway space imaging
timeFrame: through study completion, from 15.05.2023 to 14.05.2024
measure: Comparison of pharyngeal dimensions of healthy and patients with OSA and HNS
timeFrame: through study completion, from 15.05.2023 to 14.05.2024
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
state: Baselland
city: Bern
country: Switzerland
facility: University Hospital Bern, Inselspital
Study officials:
References: