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

NCT06154577 | Completed

• 1 other identifier: 2023-00117
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea; Sleep-Disordered Breathing

Keywords

hypoglossal nerve stimulation; ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 examination

• Comparison of pharyngeal dimensions between visual assessment and tongue morphology and posterior airway space

  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.

  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

  through study completion, from 15.05.2023 to 14.05.2024

• Information gain through from tongue morphology and posterior airway space imaging

  through study completion, from 15.05.2023 to 14.05.2024

Study Arms (2)

Obstructive sleep apnea patients

39 obstructive sleep apnea patients with hypoglossal nerve stimulation

Diagnostic Test: Ultrasonography

Healthy controls

15 healthy control participants

Diagnostic Test: Ultrasonography

Interventions

Ultrasonography DIAGNOSTIC_TEST

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

Healthy controls; Obstructive sleep apnea patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cantonal Hosptal, Baselland: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (2)

Kantonsspital Baselland

Liestal, Basel-Landschaft, 4410, Switzerland

Location

University Hospital Bern, Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

• Tschopp S, Janjic V, Lee Y, Chen A, Chao PY, Caversaccio M, Borner U, Tschopp K. Backscattered Ultrasonographic Imaging of the Tongue and Outcome in Hypoglossal Nerve Stimulation. Otolaryngol Head Neck Surg. 2025 Jun;172(6):2134-2140. doi: 10.1002/ohn.1251. Epub 2025 Apr 7.

  PMID: 40192006 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 4, 2023
• Study Start: May 15, 2023
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)