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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Sleep-Disordered Breathing
• Intervention / Treatment: Diagnostic test: Ultrasonography

• Study Type: Observational
• Enrollment (Estimated): 54

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • University Hospital Bern, Inselspital
    • Contact: Urs Borner, PD Dr. med.; Phone Number: +41 31 632 29 41; Email: hno.poliklinik@insel.ch
  • Baselland
    • Liestal, Baselland, Switzerland, 4410
      • Recruiting
      • Kantonsspital Baselland
      • Contact: Kurt Tschopp, Prof. Dr. med.; Phone Number: +41 61 925 34 54; Email: hno.liestal@ksbl.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

39 obstructive sleep apnea patients with hypoglossal nerve stimulation and 15 subjects in the control group

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obstructive sleep apnea patients; 39 obstructive sleep apnea patients with hypoglossal nerve stimulation	Diagnostic test: Ultrasonography; Assessment of tongue morphology and posterior airway space using ultrasonography (AmCAD-UO, CE mark NB1639)
Healthy controls; 15 healthy control participants	Diagnostic test: Ultrasonography; Assessment of tongue morphology and posterior airway space using ultrasonography (AmCAD-UO, CE mark NB1639)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of therapeutic success with hypoglossal nerve stimulation	Success is defined as apnea-hypopnea index in the most recent sleep testing ≤ 20/h and 50% reduction from baseline	Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cantonal Hosptal, Baselland
• Collaborators: Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ultrasonography; hypoglossal nerve stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2023-00117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No