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

Key facts

Who runs it
Cantonal Hospital, Baselland
Where
Switzerland2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
65 people enrolled
Started
15 May 2023
Ended
29 May 2024
Type of study
Observational, 2 groups
Treatments tested
  • Ultrasonography
Record updated
5 June 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Patients younger than 18 years
  • unwillingness to give informed consent
  • incapable of performing Müller's maneuver
  • pregnancy

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Obstructive sleep apnea patients

    39 obstructive sleep apnea patients with hypoglossal nerve stimulation

    Treatment: Ultrasonography

  • Healthy controls

    15 healthy control participants

    Treatment: Ultrasonography

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Publications
Record updated
5 June 2024